A weight management programme for fathers of children aged 4 11 years: cultural adaptation and the Healthy Dads, Healthy Kids UK feasibility RCT

Article history

The research reported in this issue of the journal was funded by the PHR programme as project number 14/185/13. The contractual start date was in May 2016. The final report began editorial review in December 2018 and was accepted for publication in May 2019. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The PHR editors and production house have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the final report document. However, they do not accept liability for damages or losses arising from material published in this report.

Declared competing interests of authors

Peymane Adab reports grants from the National Institute for Health Research (NIHR), Birmingham City Council and Zhejiang Yongning Pharmaceutical Co. Ltd (Taizhou, China) during the conduct of the study, and is a member of the NIHR Public Health Research (PHR) funding committee. Clare Collins reports being involved in the development of the original Healthy Dads, Healthy Kids (HDHK) intervention and previous evaluations. Furthermore, she is supported by an Australian National Health and Medical Research Council Senior Research Fellowship and a Faculty of Health and Medicine Gladys M Brawn Senior Research Fellowship at the University of Newcastle. Amanda Daley reports being a member of the NIHR Health Technology Assessment (HTA) Clinical Trials Committee, from July 2014 to July 2015. Emma Frew reports grants from NIHR and Birmingham City Council, outside the submitted work. Kate Jolly reports grants from NIHR and funding for the intervention from local authorities in the West Midlands and the South West during the conduct of the study; she is part funded by the NIHR Collaborations for Leadership in Applied Health Research and Care (CLAHRC) West Midlands and is a subpanel chairperson of the NIHR Programme Grants for Applied Research panel. Laura Jones reports grants from the NIHR PHR programme during the conduct of the study and personal fees from North 51Bionical (Willington, UK), outside the submitted work. Miranda Pallan reports grants from NIHR during the conduct of the study for HTA 12/137/05: cultural adaptation of an existing children’s weight management programme: the Child weigHt mANaGement for Ethnically diverse communities (CHANGE) intervention and feasibility randomised controlled trial. Philip Morgan reports that he developed the Healthy Dads, Healthy Kids programme.

Copyright statement

© Queen’s Printer and Controller of HMSO 2020. This work was produced by Jolly et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

2020 Queen’s Printer and Controller of HMSO

The epidemiology of overweight and obesity in men

Overweight and obesity are major public health challenges. Obesity is associated with an increased risk of diseases including type 2 diabetes mellitus, cardiovascular disease, cancers (e.g. of the colon) and osteoarthritis. 1 It is also associated with higher rates of depression. 2 For each increase in body mass index (BMI) of 5 kg/m², mortality increases by 30% and median survival reduces by 2–4 years for people with a BMI of 30–35 kg/m² compared with those with a BMI of 22.5–25 kg/m². 3 Owing to its associations with many long-term medical conditions, the cost of obesity is high. Public Health England estimated that obesity cost the NHS in England £6.1B in the year 2014–15 and the wider costs to society were estimated at £27B. 4

Men are at a higher risk of overweight and obesity than women. 5 Inequalities are evident, with a higher proportion of men in the lowest income quintile having a very raised waist circumference (> 102 cm) (38%, vs. 32% in the highest income quintile), which puts them at high risk of the long-term conditions associated with obesity. 6 In addition, compared with white Europeans, people of South Asian ethnicity living in England tend to have a higher percentage of body fat at the same BMI and more features of the metabolic syndrome at the same waist circumference. 7 The proportion of men who want to lose weight varies by age group, with the highest proportions among those aged 35–44 years (46%) compared with 39% of those aged 25–34 years and 44% of those aged 54–64 years. 6 Entrance into fatherhood is associated with an increase in BMI trajectory for both fathers who reside and fathers who do not reside with their children. 8 In the 2016 Health Survey for England,6 39% of men reported using some form of weight management aid: the most popular were gyms or another form of exercise (31%), 7% used websites or mobile phone applications, 6% used activity trackers or fitness monitors and only 2% attended dieting clubs. 6

In terms of dietary behaviours, men and women have suboptimal diets for long-term health. 9 Only 24% of men in England report eating at least the recommended five portions of fruit and vegetables each day5 and only 13% of men aged 19–64 years consume below the recommended amount of free sugars. 9

In conjunction with the high rates of overweight and obesity and poor dietary practices, men have become less physically active. Although 66% of men self-report meeting the UK government guidelines10 of achieving at least 150 minutes of moderate physical activity or 75 minutes of vigorous activity per week,11 objective measurement shows this to be an overestimate. 12 The most recent comparison of population-based objective measurement of physical activity by the Health Survey for England was in 2008,13 which found that only 5% of men aged 35–64 years achieved the recommended activity level. Overall, 26% of men in England are classified as inactive, namely undertaking < 30 minutes of physical activity each week. 11 People from Asian, black and Chinese ethnic groups were more likely to be inactive than those from white or mixed ethnic groups. 14 After having children, men’s physical activity levels generally reduce. 15–17

Evidence of the effectiveness of weight management programmes for men

In a series of systematic reviews, Robertson and colleagues collated the evidence for the management of obesity in men. 18 Fewer men than women joined weight management programmes, but, once they joined, they had higher retention rates and a similar or greater percentage weight loss than women. A meta-analysis of male-only weight loss interventions revealed a clinically significant difference in weight change favouring interventions over no-intervention controls at the last reported assessment [–5.66 kg, 95% confidence interval (CI) –6.35 to –4.97 kg]. 19 Successful men-only weight loss programmes have been run in football clubs20 and workplaces,21 tapping into a shared identity associated with their club or workplace. 18

Robertson et al.’s18 reviews identified no eligible studies that looked at how to increase the engagement of men in weight management interventions. However, many men said that a health concern motivated them to lose weight, rather than a concern about their appearance. 18 A qualitative synthesis of 22 studies18 identified that men felt an individual responsibility for their weight gain, and that men from socioeconomically disadvantaged communities were often constrained by economic circumstances from healthy eating and exercise. To date, few studies have explored the beliefs of men from minority ethnic groups in the UK. 22 The qualitative review18 also identified the features associated with successful weight loss programmes in men. These included group-based programmes and social support, promoting engagement with the use of humour, accountability and adherence, and goal setting. 18 Men also valued a personalised approach that took account of their individual needs, and individual tailoring of advice assisted weight loss.

The epidemiology of overweight and obesity and physical activity in children

Overweight and obesity in children (aged 2–15 years) has generally increased since the 1990s, with a rise from 1995 to 2005, but an overall levelling off in recent years, with a childhood obesity prevalence of 16% in 2016. 5 However, underlying this is a widening trend in inequalities, with overweight and obesity prevalence continuing to increase in more socioeconomically deprived communities. In 2017–18, 9.5% of children aged 4 or 5 years in England were classified as obese, with a further 12.8% classified as overweight. 23 The prevalence of overweight and obesity increases during the primary school years, with 20.1% of children aged 10 or 11 years classified as obese and a further 14.2% classified as overweight. 23 Ethnic differences in the prevalence of obesity have been shown in children aged 10 or 11 years, with 29.0% of black Caribbean and African children and 24.8% of South Asian children (originating from the Indian subcontinent) living with obesity, compared with 18.4% of white British children. There are socioeconomic differences in childhood obesity, with prevalence in the most socioeconomically deprived areas double that of the least deprived areas for children aged 4 or 5 years (5.7% of children in the least deprived decile were obese, compared with 12.8% of those in the most deprived decile) and 10 or 11 years (11.7% in the least deprived decile vs. 26.8% in the most deprived decile). 23

Engaging in adequate levels of physical activity is important for children in the short, medium and long term. 24 Apart from the increased risk of obesity with physical inactivity, there are many other negative physical and mental health consequences. 25,26 Active children are less likely to suffer the adverse health consequences of physical inactivity in adulthood, as habits formed in childhood track forward into adulthood. 26 In children, physical activity is essential for motor development, cognitive improvement, psychosocial health and cardiometabolic health; physical activity reduces body fat and can increase academic achievement. 25

Current UK recommendations27 for physical activity in children aged ≥ 5 years are that they should be at least moderately active for a minimum of 60 minutes every day. This is the minimum level, and there is a recommendation that children should engage in moderate to vigorous physical activity for up to several hours each day. It is also recommended that vigorous intensity activity, including muscle- and bone-strengthening activities, should be undertaken at least 3 days each week. 27

However, national objectively measured data using accelerometry shows that, in 2008, the proportion of boys and girls classified as meeting the minimum recommendations27 were 33% and 21%, respectively. 13 In children aged 4–10 years, 51% of boys and 34% of girls met the recommendations, compared with 7% of boys and no girls aged 11–15 years. Data from England’s 2016 Report Card on Physical Activity28 suggest that overall physical activity levels in children and young people has declined. Recent objective data on children’s physical activity come from regional studies. 29 A study from Bristol reported that boys and girls aged 5 or 6 years undertook a mean of 72.4 [standard deviation (SD) 20.7] and 62.3 (SD 16.2) minutes, respectively, of physical activity daily, and that there was a decrease in physical activity and increase in sedentary time in boys and girls between the ages of 5 or 6 and 8 or 9 years. 30 This demonstrates the importance of strategies to encourage and promote physical activity into later childhood and beyond.

Family physical activity and eating behaviours

Parental support, direct help from parents, support from significant others and perceived and actual physical competence have been shown to be positively associated with children’s physical activity levels, although the association with parental physical activity is inconsistent. 31 Promising strategies to involve parents in interventions to increase their children’s physical activity include engaging family members in a family physical activity programme, parent training, family counselling or preventative messages during family visits. 32 A systematic review of interventions to promote physical activity in children highlighted the limited evidence of the effect of interventions targeting low socioeconomic populations and interventions aimed at the home environment. 33

Family eating practices are associated with child eating behaviours. 34 Eating meals together as a family, parents role modelling healthy eating behaviours and having healthy foods available in the home have been shown to be positively related to the eating habits of children. 35–39 In addition, parents who have an involved and caring parenting style rather than a controlling style have children who eat healthier diets. 40,41 UK evidence from the National Diet and Nutrition Survey shows that whether or not families eat together is influenced by parents’ work schedules, children’s age and appetite for earlier eating than their parents, their child-care regimes, their extracurricular activities and the problem of co-ordinating different food preferences and tastes. 42

The health inequalities in obesity experienced by people from minority ethnic groups is likely to be, in part, affected by different dietary practices and beliefs about physical activity. 43,44 However, food practices of minority ethnic groups are heterogeneous and, although affected by ethnic background, they are also affected by age, religion, socioeconomic circumstances, geographical area and generation. 43 Factors that influence food practices in minority ethnic groups include sociocultural norms and affordability and accessibility of food; these need to be seen in the context of poverty and there have been calls for culturally sensitive interventions that build on positive food practices and adopt a family- and community-centred approach. 43 A systematic review44 of qualitative literature relating to the health beliefs of British South Asians on lifestyle diseases highlights the primacy of social and cultural norms over an individualised approach to lifestyle change, and many barriers to physical activity and exercise.

The Healthy Dads, Healthy Kids intervention

The Healthy Dads, Healthy Kids (HDHK) programme was developed by a team of researchers in Australia, including some of authors of this report (PM, CC and MY), and was established to address weight management in fathers, but in the context of their families, such that changes in their health behaviours would positively affect their children. A highly novel aspect to the intervention was that children also play a major role in motivating and helping their father to maintain his behaviour change.

The HDHK programme has been rigorously evaluated in two randomised controlled trials (RCTs) in Australia. 45,46 In the community RCT with trained facilitators in disadvantaged areas, the authors reported a mean difference in weight of the fathers of 3.4 kg (95% CI 2.1 to 4.7 kg) in favour of the intervention at 14 weeks, compared with a wait-list control. They also observed significant group-by-time reductions in children’s BMI z-scores (–0.10, 95% CI –0.21 to 0.00), physical activity levels and diet quality, favouring the intervention group. 45 A larger-scale community roll-out has demonstrated clinically meaningful weight loss sustained to 1 year in fathers (3.8 kg loss; 95% CI 3.1 to 4.6 kg), and a significant mean reduction in BMI z-scores (–0.12, 95% CI –0.17 to –0.07) in children. 47 Positive effects reported via qualitative research were improved family relationships and involvement of the fathers and children in joint activities. 47 In additional, the quantitative findings showed that participation in the HDHK programme positively affected fathers’ co-physical activity with their child and beliefs about healthy eating, which mediated changes in children’s diet and physical activity behaviours. 48 Although the intervention has been evaluated in Australia, its transferability to a multiethnic UK setting needs to be tested.

Rationale for the Healthy Dads, Healthy Kids UK study

This study addressed a commissioned call from the National Institute for Health Research (NIHR) Public Health Research programme for research on weight loss services for men. The recruitment of fathers with their children, and the involvement of mothers/partners in the intervention, meant that meaningful health gains were possible for the whole family. There was the potential for sustained behaviour change as a result of family behaviour change, which would help to break the cycle of intergenerational obesity.

A patient and public involvement (PPI) group was consulted in the development of the research proposal and, through this group and the research team, it was identified that there would be a need to adapt the Australian version of the HDHK programme.

As a result of changes in migration patterns over the previous 20 years, urban populations, such as that of the West Midlands, have become more complex and ‘superdiverse’. Superdiversity is characterised by overlapping variables including country of origin, ethnicity, language, religion, regional/local identities, migration history and experience (influenced by sex, age, education, specific social networks and economic factors) and immigration status (encompassing a variety of entitlements and restrictions). 52,53 Such complexity in the population has created unique challenges with regard to how we identify and respond to the health needs of all members of a superdiverse society.

Cultural adaptations have been described by Resnicow et al. 54 with regard to different dimensions of cultural sensitivity: surface and deep structure. An intervention that addresses surface-structure adaptations would match intervention materials or messages to ‘fit’ within a specified culture – be it by matching on language, food, music or location, and including items of familiarity to the target population to help them engage with the intervention. Deep-structure adaptations would address the core cultural values or ethnic, cultural, historical, social or environmental factors that may influence specific health behaviours. 54

In relation to the delivery of the HDHK programme, a number of issues to be addressed in the adaptations were known to the research team from the outset, namely awareness of certain cultural barriers to engagement with behaviour change activities in some black, Asian and minority ethnic (BAME) groups. For example, participation in sports and physical activity outside the home may be discouraged among girls, and cultural dress codes can restrict physical activity.

In addition, the Australian programme was predominantly delivered by teachers, and this model was considered unlikely to be replicable in the UK owing to different incentives to deliver after-school activities in the two countries. In the Australian studies, the HDHK programme was delivered mainly in schools, often by a physical education teacher who was able to use the initial training towards their continuing professional development requirement. Our experience of working with UK schools suggested that teachers are overburdened and schools are regularly approached to take part in projects and initiatives. 55 There are similarities between Australia and the UK in the proportion of men who are overweight or living with obesity. 5,56 Australian guidance for adult fruit and vegetable intake is five or six portions each day, whereas the UK’s guidance is five portions. 57 About one in four men in the UK report adequate fruit and vegetable consumption,58 but < 5% of Australian men have an adequate intake. 59 Australian guidelines also separate fruit and vegetable portions, unlike the UK. 57 Guidance in relation to alcohol consumption is similar. Given these relatively modest differences, we considered that the intervention should be transferable with some adaptions.

However, it was also agreed that, as part of the study, cultural adaptation would need to be informed by the community and that changes would need to be made before implementing the HDHK programme in the UK setting.

Potential benefits of the adapted Healthy Dads, Health Kids UK programme

The potential benefits to the men of the adapted HDHK-UK programme are weight loss, improved physical activity levels and improved diet quality, which can result in a reduction in risk for a wide range of health conditions including type 2 diabetes mellitus, cardiovascular disease, certain cancers, arthritis and other musculoskeletal symptoms. 60 Increased physical activity is also associated with mental well-being61 and joint activities with their children may result in closer relationships and bonding. 62 For the children, there are the benefits of healthier eating patterns and increased physical activity, resulting in a lowered risk of developing obesity,63 potentially improved attention and outcomes at school,64 improved social–emotional well-being and a shared activity with their father potentially leading to a closer relationship. 65

Study aims

The overall aim of HDHK-UK study was to modify an existing weight management and healthy lifestyle programme for fathers and their children (aged 5–11 years) to be culturally acceptable in a UK multiethnic population and to assess the feasibility of conducting a RCT. The study was delivered in two phases.

Phase 1: adaptation of the existing programme

The aim of phase 1 was to modify an existing weight management and healthy lifestyle programme for fathers and their primary school-aged children45,46 so that it is culturally acceptable in a multiethnic population in the UK. The cultural adaptation (phase 1a) drew on the findings of qualitative interviews and focus groups from an ethnically diverse population in areas of socioeconomic disadvantage, as well as findings from a study that was culturally adapting a weight management programme for children in the same population. 53 The specific objectives for phase 1a were to:

• explore the cultural (ethnic, religious and socioeconomic) acceptability of the programme elements and proposed questionnaires with fathers from a range of ethnic, religious and socioeconomic groups

• increase the cultural acceptability of the programme using theoretically informed adaptations so that it is acceptable and accessible to a UK population with ethnic, religious and socioeconomic diversity.

In phase 1b, an uncontrolled feasibility trial was undertaken at two sites to explore the acceptability of the adapted programme and research methods. The specific objectives for phase 1b were to assess the:

• feasibility of delivering the adapted intervention and the feasibility of recruitment and follow-up

• acceptability of the HDHK-UK programme in an ethnically diverse population and make refinements to the programme based on the facilitators’ and participants’ feedback.

Phase 2: feasibility randomised controlled trial

The aim of phase 2 was to assess the feasibility of delivering the adapted intervention, the feasibility of recruitment and follow-up and the feasibility of a future definitive RCT. This was achieved using a two-arm RCT. Participants were randomised to the intervention or control arm in a ratio of 2 : 1, respectively. Data were collected from participants [fathers and their child(ren)] at baseline and at 3 and 6 months from the start of the intervention. Qualitative methods were also used as part of the evaluation. The specific objectives were to:

• assess the acceptability of a UK-adapted weight management and healthy lifestyle programme for overweight/obese fathers of primary school-aged children in an ethnically diverse population and make refinements to the programme based on facilitator and participant feedback

• determine levels of adherence to the programme

• assess fidelity of intervention delivery and feedback from facilitators and modify the facilitator training programme if required

• assess whether or not participants are willing to be randomised

• assess whether or not the expected recruitment rate for a subsequent full-scale RCT is feasible and to identify successful recruitment strategies

• explore the ability to obtain educational attainment data for children

• explore participants’ and facilitators’ perceptions of the intervention, trial participation and processes

• provide estimates of the variability in the primary outcome

• test the components of the proposed RCT to determine the feasibility of the protocol.

Study partners

The feasibility study had two key study partners that were closely involved in the set-up and delivery of the trial.

Study management

The study was overseen by two groups: the Study Steering Committee (SSC) and the SMG.

Funding, ethics approval and study registration

Study funding was granted in October 2015 by the NIHR Public Health Research programme (reference number 14/185/13). The randomised trial was registered with the International Standard Randomised Controlled Trial Number (ISRCTN) registry January 2017.

Ethics approval for the two phases of the study was obtained from The University of Birmingham Science, Technology, Engineering and Mathematics Ethics Review Committee. Phase 1a was approved on 22 April 2016 (ethics reference number ERN_15–1287), phases 1b and 2 were approved on 16 January 2017 (ethics reference number ERN_16–1323). A number of amendments were submitted for review throughout the study, as detailed in Appendix 1. Important changes to the original protocol were (1) the widening of the eligibility criteria for phases 1b and 2 to include men categorised as overweight or with a waist circumference of ≥ 94 cm, (2) the inclusion of the Strengths and Difficulties Questionnaire at follow-up for phase 2 and (3) stratification of the randomisation.

Qualitative study methods

Findings of the qualitative component

Content of the programme

Findings from the CHANGE study

We also drew on findings from the CHANGE study, led by one of the study team (MP). The CHANGE study was a cultural adaptation and feasibility trial of a children’s weight management programme attended by parents and children in Birmingham, UK. 53 This included a detailed process of cultural adaptation of an existing weight management programme for overweight children aged 4–11 years. The CHANGE study included interviews/focus groups with 43 parents of Bangladeshi or Pakistani heritage who had either completed the programme, partially attended or not attended the programme.

Many of the findings from the CHANGE study supported those from the interviews and focus groups in phase 1a of HDHK-UK. The CHANGE study participants, who were all parents (predominantly mothers) of overweight children of Pakistani or Bangladeshi heritage, confirmed the importance of the programme taking place in a close, familiar location and at a convenient time. They supported a programme that involved children in all of the sessions, rather than just some, as it was felt that they need to learn how to change their behaviour first hand and would respond differently to messages given by someone other than their parents. Parents reported that the nutritional content should be relevant to traditional South Asian diets, while acknowledging the importance of also talking about Western foods, as, typically, their children’s diets consisted of a mixture of foods. Other key findings were the value of sharing experiences and supporting each other in the group environment and the need for assistance with making behavioural changes at home.

Adaptations recommended as a result of the Dads And Daughters Exercising and Empowered programme

At the time of HDHK-UK, the Australian team that developed the HDHK programme recommended changes to the HDHK programme as a result of a new programme they had developed and were evaluating for fathers and their daughters: the DADEE programme. 67 HDHK had nine sessions, with the children attending seven of the sessions, whereas the children in the DADEE programme attended all of the sessions. Feedback from the participants and those delivering the DADEE programme was that fathers and children attending every session was an improvement on the HDHK programme.

Another difference in the DADEE programme was to start the session with a 15-minute joint session with the fathers and children together in which they recapped the previous session and discussed how they had got on with homework tasks. Again, this was felt to be a successful adaptation from the HDHK programme, in which the fathers and children immediately went into separate sessions.

Adaptation process

We then took the findings from the qualitative study and applied the Liu et al. 69 typology to consider which of the items in the typology these factors addressed and then considered how this could be operationalised. This final stage drew on the qualitative findings, the CHANGE study,53,70 previous experience from the Australian delivery of the HDHK programme and the delivery of the DADEE programme. 67

The adaptation process was undertaken by two members of the research team (MS and KJ). An example of how the process was undertaken is as follows. We identified, through the qualitative data, that the facilitator needed to be able to adapt physical activities to reduce physical contact between fathers and daughters for some families of Bangladeshi or Pakistani heritage. This fitted within the Liu et al. 69 typology as ‘gender considerations’. We then ensured that the facilitators had training that included adaptations to the physical activities to limit the amount of close physical contact.

Changes to the Healthy Dads, Healthy Kids programme

Adaptations were made in three key areas of the programme: (1) programme promotion, recruitment and follow up; (2) programme delivery; and (3) programme content. No changes were made to the theoretical underpinning of the programme; most changes were at the surface structure level, but some, such as branding the programme as a father–child activity programme and acceptability of physical activities for fathers and daughters, were deep structural adaptations.

However, it is important to note that we were unable to remove the inclusion criterion of obese or overweight, despite the qualitative research recommending that this was changed, given that men’s weight management was the objective of the funding call. Most of the components interpreted as important in the qualitative data were already built into the programme. As a research team, our main concerns were whether or not the content of the resources were too difficult to be delivered with fidelity by a facilitator who was not a teacher and whether or not the supporting workbook was too detailed. Given the very positive findings from the Australian studies, the research team took the approach of making fairly limited changes before running the uncontrolled feasibility trial, then assessing whether or not further changes were required.

The adapted Healthy Dads, Healthy Kids UK programme

Detail of the final adapted HDHK-UK programme is described using the Template for Intervention Description and Replication (TIDieR) checklist (Table 3).

Discussion and conclusions

The aim of this work package was to adapt an existing weight management programme for overweight fathers and their children for superdiverse communities living in socially/economically disadvantaged communities in the UK, particularly encouraging members from the Pakistani and Bangladeshi communities. As a result, we sought the views of potential service users (fathers/grandfathers) and those who may act as gatekeepers (mothers/grandmothers). Our adaption process was theoretically informed with the use of the Liu et al. 69 typology of cultural adaptation.

Through our collection of qualitative data, we were able to identify a number of cultural adaptations to encourage attendance from both BAME and white British communities. As a result, our suggested cultural adaptations are not aimed to address specific community beliefs or practices, but to accommodate members from a range of communities. Many of the issues identified as important are those that apply to any group-based activity involving children, although there were some deep structural adaptations.

However, the application of the taxonomy was difficult for a number of reasons. First, the taxonomy focuses on ‘ethnic matching’ in the conception, planning and implementation phases, which can be complex given the changing nature of designing and adapting weight management programmes in a UK context. In addition, our data showed very little support for ethnic concordance. Second, there is an overemphasis on surface-level adaptations (addressing language needs, culturally matched foods, visual images) that are specific to catering to non-white groups that have well-established lifestyle practices, rather than recent migrant groups or second-/third-generation families. Third, limited consideration is given to wider social determinants affecting families, rather than individuals, for example, mixed employment practices in a single household, single-parent families or those who are reliant on the support of extended family (social networks). Hence, the cultural adaptations that we have listed and implemented as part of the intervention are responsive to a ‘family context’.

In a systematic review of the effectiveness of cultural adaptations for interventions aimed at smoking cessation, diet or physical activity in ethnic minorities, Nierkens et al. 85 reported that culturally targeted behavioural interventions may be more effective if they are implemented as a package of adaptations, at a family level, and where the adaptation results in a higher intensity of the intervention than the original unadapted version. This resonates well with the family focus of the HDHK programme and the adaptations made to programme delivery and content. In addition, the Nierkens et al. 85 review found no evidence that the level of adaptation (deep/surface) influenced effectiveness; our adaptation resulted mainly in surface-level changes. 85

There are very few pilot or feasibility studies that have evaluated the process of culturally adapting lifestyle intervention programmes in the UK, with the majority completed in the USA with Latino, Hispanic and African-American minority communities. 86–88 Findings from these studies are not wholly applicable to populations living in the UK. In addition, Sidhu et al. 89 found that cultural adaptations to lay-led, group-based lifestyle interventions were inconclusive with regard to increased effectiveness, although structural adaptations were successful in increasing attendance, albeit mostly among women. 90,91 Nevertheless, there is poor reporting of cultural adaptations and their theoretical justifications for being used.

Notably, the CHANGE study,53 described earlier, played a fundamental role in theoretically guiding the early stages of our study and informed the nature of our cultural adaptation. 53 Lessons learned from the previous application of the Liu et al. 69 typology in the cultural adaptation for the CHANGE study were brought forward into the cultural adaptation of the HDHK intervention. Many of our surface-level suggestions for altering content and presentation of material, such as inclusion of BAME foods and images, were also supported by the findings of the CHANGE study.

There were a number of challenges during the completion of this study phase. Recruitment of fathers to take part in interviews or focus groups was difficult. As a result, recruitment was prolonged and labour intensive, as a result of travel, postal mail-out and predominantly using a face-to-face approach (canvassing) to identify eligible participants. Furthermore, we struggled to engage with Pakistani and Bangladeshi fathers, but were successful in engaging mothers from these communities using an approach by means of research advocates in high ethnic density areas. The fact that almost half of those interviewed were women does mean that there may have been issues relevant to men that we missed. Furthermore, along with providing an incentive to complete interviews (e.g. high-street voucher) and collecting data in participants’ places of employment, beauty salons, a meeting room in a school and homes, we were able to reach saturation overall, although not for specific ethnic groups.

We were successful in gathering data from a heterogeneous sample in our non-white cohort, including non-English-speaking first-generation parents, second-generation parents and those in mixed-heritage marriages. To accommodate non-English-speaking participants (exclusively Pakistani mothers), we sought to involve a researcher with substantial experience of completing qualitative data collection in the West Midlands Pakistani community. Nevertheless, among this group, there was greater preference to complete a one-to-one interview rather than taking part in a focus group, with fewer members attending scheduled focus groups despite confirming attendance by telephone. This was more time-consuming and costly than originally planned for.

Our approach of showing participants material from the Australian version of the intervention was successful in narrowing the focus of conversations to the intervention as a whole, the activities involved (both physical play and education sessions) and the supplementary materials given to attendees to take away from the sessions. This was appropriate in the context of this study because we were not looking to redevelop the programme, but instead preserve the essence of the Australian programme while making it suitable to be delivered in a local context. As a result, we felt that our findings were useful and relevant for making suggested cultural adaptations to the intervention. Hence, we successfully achieved our aim of a theoretically guided cultural adaptation of the HDHK programme for the UK context, keeping changes to the programme to the minimum necessary.

Although we were able to recruit a diverse sample, we may have benefited from greater participation from Pakistani and Bangladeshi fathers, either migrant or British-born, given that the literature identifies these as groups who could benefit most from attending the intervention. Participants may have benefited from viewing Australian materials for a longer period of time, having the opportunity to view video clips of the HDHK sessions or even viewing the materials before the interview/focus group. Importantly, greater consideration needs to be given to recruitment strategies to engage with fathers/families from superdiverse communities, as this can be time-consuming and requires considerable effort from members of the research team.

An additional approach to elicit preferences in relation to the importance of individual components or modes of delivery of a new or adapted intervention would be to use preference elicitation techniques. We were not funded to do this, but it would have identified the trade-offs between characteristics such as timing of delivery and session length, for example.

Study setting

The study took place in two local authority areas of the West Midlands in the UK. Both areas are ranked to be within the 20% most deprived authorities in England, with lower life expectancy than the national average and around one-third of children living with families of low income. 71,93 Census data collected in 2011 showed that unemployment was higher at both sites (7.5% and 7.3%) than the overall national unemployment rate for England (4.4%). Both areas were ethnically diverse: site A – white British (66.7%), Asian and Asian British (18.9%); site B – white British (69.9%), Asian and Asian British (19.2%) (overall ethnic diversity in England: white British, 85.4%; Asian/Asian British, 7.8%). 93

Facilitator recruitment and training

At each of the study sites, the local authority public health teams were asked to propose or recommend facilitators to deliver the HDHK intervention programme, considering the required characteristics. Each course required two facilitators for delivery: one facilitator for the father-only education session and the other for both the children-only education session and the joint father-and-child physical activity session. An additional support facilitator/helper was also needed for the children-only sessions, as recommended by UK child supervision guidelines. 94 Training was to be provided, but HDHK facilitators ideally needed to have previous experience of working with children and families. The HDHK programme training materials advise that a successful programme facilitator should be credible, relatable and likeable, and that it would be preferable for the father-only session to be delivered by a male facilitator. Facilitators were required for the delivery of six courses across two sites: two courses for phase 1b (courses A and B) and four courses for phase 2 (courses 1–4).

At site A, the programme was delivered by the local authority Healthy Lifestyles Team (‘lifestyles team’) and an independent fitness instructor, with support from the study researchers. The lifestyles team, employed by the city council, had experience in delivering a range of health promotion programmes and support to adults and, in some cases, children across the region, including programmes such as weight management and smoking cessation. The lifestyles team delivered the father-only education session. The fitness instructor delivered the child-only education sessions and the joint father-and-child physical activity sessions.

At site B, the physical activity project manager in the public health commissioning team was keen that the HDHK programme should be delivered by a third-sector organisation that, at the time, delivered physical activity education and after-school clubs in schools in the region. This was to avoid a plethora of different organisations interacting with schools with different offers. The staff from this organisation (referred to hereafter as the ‘coaching organisation’) were qualified children’s activity professionals with extensive experience of activity coaching.

Owing to unexpected delays [described in Chapter 5, Site B (course B)], in addition to the coaching organisation, the university research team appointed staff of a local leisure centre to deliver three HDHK courses (courses B, 2 and 3) at site B. At these courses, the father-only education sessions were delivered by three different staff (personal trainer, health and well-being manager and gym manager). The children-only education session and joint physical activity sessions were delivered by a team of sports coaches. Two of the leisure centre sports coaches worked for both the leisure centre and the coaching organisation; therefore, the courses were delivered at two venues: the leisure centre (courses B, 2 and 3 – employed by the leisure centre) and a community centre (course 4 – employed by the coaching organisation).

The intention was to recruit and train facilitators who would deliver courses during both phase 1b and phase 2; however, changes experienced at local authority level and limitations to staff availability resulted in a change of facilitators throughout the study, meaning that several facilitator training sessions were delivered. The facilitator training was mainly undertaken by staff from the Fatherhood Institute who were experienced in offering other training programmes to fathers. They had themselves undergone a bespoke 2-day training-the-trainer course delivered by Philip Morgan, who developed the Australian HDHK programme. The training involved the modelling of the intervention by the trainers, opportunities to practise session delivery with feedback and a half-day session on the physical activity component. This training took place before the research grant was awarded, so there was an 18-month gap between training the Fatherhood Institute and the Fatherhood Institute’s delivery of the training. The Fatherhood Institute, in turn, trained some of the University of Birmingham research team that subsequently delivered facilitator training. The facilitator training programme drew on training slides developed by the Australian research team and included modelling of delivery of the programme and opportunities to practise delivery of both the father-only education sessions and the physical activity sessions. Facilitators were provided with a delivery manual and access to video-recordings of the delivery of the various activities by the Australian team. The physical activity sessions were omitted from the facilitator training when the trainees were experienced sports coaches. Training sessions are summarised in Table 4 and further detail around the circumstances that led to a high turnover in staff are presented in Chapter 5, Set-up and delivery of Healthy Dads, Healthy Kids sessions for the uncontrolled feasibility trial.

Delivery venues

The intervention programme was delivered at a number of community venues across the two sites, depending on the availability, accessibility and location of the facilitators. The venues were required to have a classroom or conference room with a computer projection facility to deliver the father-only education sessions, and a safe and comfortable sports hall with an available range of play equipment for the child-only and father-and-child physical activity sessions. At site A, phase 1b (course A) was delivered in a primary school and phase 2 (course 1) was delivered at a youth centre. At site B, three of the courses were delivered in a leisure centre (courses B, 2 and 3) and one course was delivered in a community centre (course 4).

Participant recruitment

Recruitment was ongoing from July 2017 to January 2018. The target was to recruit 30 participants for phase 1b and 90 participants for phase 2. A number of different recruitment methods were used to identify participants for both phase 1b and phase 2, including recruitment stands at local venues (shopping, leisure and community centres) and speaking at school assemblies, parent evenings and teacher meetings. Bright, attractive flyers were distributed at school gates, community centres, places of worship and large workplace organisations. Facebook (Facebook, Inc., Menlo Park, CA, USA; www.facebook.com) and Twitter (Twitter, Inc., San Francisco, CA, USA; www.twitter.com) pages were set up for the study, promoted by the youth centre at site A and by the local authority public health team and leisure centre at site B.

Potential participants who were interested in the study either provided their details to a research team member at a recruitment event or were encouraged to contact the team using the details that were shown on the flyer or social media pages. When contact was made, interested participants were asked if they had any further questions and their eligibility was discussed according to the inclusion and exclusion criteria. To take part in the study the participants had to be:

• Men who were overweight or living with obesity, aged 18–65 years with a BMI of ≥ 25 kg/m² (23 kg/m² for minority ethnic groups) and/or a waist circumference of ≥ 94 cm (37 inches).

• Fathers/stepfathers/father figures of primary school-aged children (4–11 years). Fathers did not have to be resident in the same household as the child(ren) to take part.

• Willing to lose weight.

Participants were asked to complete the Physical Activity Readiness Questionnaire [see the project web page: www.journalslibrary.nihr.ac.uk/programmes/phr/1418513/#/ (accessed 25 November 2019)], which screens for conditions that might preclude safe exercise. If any question responses were positive, they were advised to seek advice from their general practitioner (GP) for direction to alternative local weight management pathways. Further exclusion criteria were as follows:

• angina or other cardiovascular disease

• orthopaedic or joint problems that would be a barrier to vigorous physical activity

• weight loss of 3 kg or 7 lbs in the 3 months prior to the programme

• fathers with diabetes who were not confident in managing their condition during exercise

• unable to speak and/or understand English

• families involved in ongoing custody or access disputes and/or any contexts with a risk of domestic violence (if a parent or other person who knew the family raised this as an issue).

Eligible participants who agreed to take part in the study were provided with information sheets for both adults and children and were required to provide written informed consent on behalf of themselves and their child (or children) aged 4–11 years. Children over 8 years of age were asked to complete an assent form to confirm that they understood the study and were happy to take part.

Data collection and randomisation

As part of the feasibility study, data were collected to test whether or not the processes of data collection that would be used in a randomised trial were acceptable to participants and researchers. In a definitive trial, the primary outcome would be the difference in fathers’ weight between the groups at 12 months’ follow-up, whereas in this study the final follow-up was at 6 months.

Appointments for baseline data collection measurements for both phase 1b and phase 2 were mainly conducted in participants’ homes. Alternative measurement locations were offered if participants were uncomfortable with a researcher visiting their home. The anthropometric measurements and questionnaire data collected are summarised in Table 5 and further detailed in the next section. Copies of the baseline questionnaire booklets are available on the project web page [www.journalslibrary.nihr.ac.uk/programmes/phr/1418513/#/ (accessed 25 November 2019)].

Participant randomisation (phase 2 only)

Father participants were block randomised using a 2 : 1 ratio of intervention-to-control group with stratification for the father’s ethnicity (white British or Irish/other ethnic group). The randomisation list was developed by the trial statistician and held in a secure database.

To ensure allocation concealment, after consent was taken and baseline measurements were complete, researchers entered the participant details into a secure, web-based randomisation website designed and maintained by the data programmers at the Birmingham Clinical Trials Unit and the system provided the participant’s treatment allocation. Participants were advised whether they were in the control or the intervention group first by text message then by a follow-up telephone call.

Follow-up appointments to collect outcome data

Follow-up data collection appointments were completed with participants 3 and 6 months after the start of the intervention programme. The appointments were conducted using the same methods as at baseline, and were conducted either at the participants’ home or at the intervention venue. Table 5 shows the time points when each measure was collected. It was not always possible for the researcher undertaking the follow-up assessment to be blinded to a participant’s allocation group, as the research team that undertook measurements also completed observation of intervention sessions.

Iterative intervention adaptations during delivery

Between phase 1b and phase 2, the session materials were further developed and adapted based on researcher observations and participant and facilitator feedback. Session feedback and guidance was also provided during the course to the facilitators to ensure that delivery was optimised throughout.

Process measures

Collection of data measuring the fidelity of intervention delivery was a key component in assessing the feasibility. Three main methods were used for information capture; these were as follows.

Sample size

As a feasibility study, a formal sample size calculation was not performed because it was not designed or powered to detect a statistically significant difference in weight change between the two treatment arms; rather, the aim was to assess if the adapted HDHK intervention is acceptable and deliverable, and also to assess whether or not the whole trial could be run as planned. Therefore, only some reasonably estimated recruitment figures were adopted to enable estimation of the feasibility outcomes with reasonable precision.

Data analysis/statistical analysis

The statistical analysis plan provides details about the presentation and analysis for the quantitative results from phases 1b and 2. This report follows the statistical analysis plan dated 8 November 2018, apart from deviations from the plan, which are described and justified in Appendix 4.

All comparisons for phase 2 were made for (1) the HDHK-UK programme versus (2) minimum intervention (information about local opportunities for physical activity plus a voucher for the family to attend a leisure centre) control group. All analyses were performed by intention to treat. Participants were analysed in the intervention group to which they were randomised and all participants were included whether or not they received the allocated intervention.

We summarised categorical data by number of responses, frequencies and percentages. Continuous data are summarised by the number of responses, mean and SD, median and interquartile range (IQR).

We present baseline demographics for the fathers in phase 1b, and by allocated group and overall for the fathers, the eldest child and all children in phase 2. Baseline questionnaire scores are presented for fathers and the eldest child by allocated group and overall for phase 2.

We analysed feasibility outcomes by pooling the two groups and presenting overall estimates with 95% CIs, as well as by allocated group. The number of responses and percentages are provided with 95% CIs when relevant. We also present the number of forms completed and the form completion rate. We summarise weight change in fathers at the 3- and 6-month follow-ups using means, SDs and within-group 95% CIs.

All clinical outcomes are summarised by allocated group only. As the study is not powered to detect any treatment effects on clinical outcomes, we do not report p-values and 95% CIs.

We define adherence according to ‘completion of the intervention programme’ and evaluate it by the number of sessions that a family attended. A family that attended at least five out of the nine planned sessions is classified as completing the programme.

We present the number and percentage of fathers and children experiencing any serious adverse event (SAE) and suspected unexpected serious adverse reaction by group. Only overnight admissions to hospital due to injury or sudden illness during a HDHK session are reported as a SAE.

No subgroup analyses were planned for this feasibility study.

All analyses were undertaken in Stata version 12.

Health economics

The economic evaluation focused on the feasibility of cost and outcome data collection to inform a future trial evaluating the cost-effectiveness of the HDHK programme. An exploratory analysis was undertaken to assess the incremental cost of the interventions. The evaluation of the intervention effectiveness was not the focus; however, we measured the mean and SD of the Child Health Utility-9 Dimensions (CHU-9D) at various time points and assessed the level of completion for other resource use and outcome questionnaires detailed below.

Changes to the protocol

Changes to the protocol are described in Appendix 1 (see Table 30) and were all approved by the funder. Changes to the eligibility criteria for phases 1b and 2 were in response to recruitment challenges.

Set-up and delivery of Healthy Dads, Healthy Kids sessions for the uncontrolled feasibility trial

Successfully aligning participant, venue and facilitator availability for the delivery of a course (courses A and B) at each site was a significant challenge. The process of recruiting sites for programme delivery, identifying and training facilitators who were then able to deliver the programme at the sites at the allotted time and recruiting participants is summarised in Figures 1 and 2.

FIGURE 1.

Descriptive timeline of processes in setting up delivery of the HDHK programme for WP1b at site A.

FIGURE 2.

Descriptive timeline of processes in setting up delivery of the HDHK for WP1b at site B.

Intervention session attendance

Attendance and completion of sessions is shown in Figure 3. In total, across both sites, eight participants attended at least one session and two participants (25%) completed the programme, that is they attended at least five of the sessions.

FIGURE 3.

Session attendance for WP1b. a, Owing to small numbers, the participant was invited to complete the course at site B.

Participant experiences of the programme

Participant experiences of the programme were collected through qualitative interviews with three fathers, two of whom completed the programme (father 1 and father 2), and one who had attended only one session. Feedback was also collected from session feedback forms. The data were collected to test the interview schedule and session feedback forms ahead of phase 2, but some of the participant feedback was also used to inform the implementation of phase 2. Owing to the small sample size, the data are not presented thematically but as a narrative of findings that informed the delivery of phase 2.

The overall feedback on the course was positive, which confirmed that, overall, the course was acceptable to the participants and there were no major concerns taking it forward to phase 2:

I’ve just found it quite . . . quite a powerful experience in terms of yeah, just being able to, I guess just reassess where we were with it all and the things that we’ve let slip . . . and yeah, the value for me especially has come from seeing my children thriving in sports . . . I think it was a brilliant scheme and I can really see the value of a scheme like this in, yeah, in any dad’s life.

Father 1

It’s been a great experience, I can’t say that I’ve kind of done 100% of what I’ve learned, but I’ve definitely made a start and seen the benefits of it in terms of lost some extra pounds and got a bit more fitter and run a bit longer, a bit better, a bit further and spent some quality time with the kids.

Father 2

When asked about the facilitators, one participant preferred the more discursive approach that was adopted by the facilitators as the programme progressed; similarly, the researchers observed this to be a good approach. Therefore, the discursive approach was recommended for facilitators in phase 2:

I think they got better throughout the weeks . . . there was definite progression . . . at the start, a couple of weeks it was very much things were read off the projector . . . But towards the end there was a real shift . . . it went from just presenting the material to using the material as a prompt and a platform to inspire discussion and inspire the sharing of experience, which was a really positive, for me anyway, a really positive outcome of the sessions.

Father 1

The facilitator’s upbeat supportive demeanour was appreciated, and emphasised the importance the role the facilitators had in helping the participants to feel at ease. Facilitators were encouraged as part of the conversations with the research team ahead of phase 2 to be positive and welcoming for the subsequent courses:

. . . it was quite nice that [facilitator name] was always there well in advance and would always welcome us in. And again, he was just brilliant with the kids and the kids enjoyed going in and they’d race up to him and give him a high five.

Father 1

The one that jumps out to me is the openness from the get-go really. There was no awkwardness in communication, there was no kind of, there was no like settling in period, it felt very welcoming and it’s true for all of them [facilitators] really; they really made a good effort.

Father 2

Similarly, the feedback for the sports coaches was positive. One participant was exceptionally positive about the coaching skills, and the benefit of their experience and skill set for the programme was also observed by the researchers. This was carried across to WP2 and emphasised the importance of recruiting facilitators with coaching skills to deliver the physical activity elements of the programme, a key reason continued efforts were made (despite the delays) to engage with the coaching organisation for delivery of at least one course in phase 2:

The two guys were brilliant . . . the quality of the coaching was there enough that the kids made some brilliant progress . . . they [participant’s children] both now own a tennis racket each ‘cause they really enjoyed playing tennis. They try and get to the park regularly and knock a ball around and they still talk about kind of the hints and tips and the coaching methods that were used. And on the way to school they try and jump over everything and leap over things and again kind of refer back to the kind of coaching that was given within the sessions. So it’s been something we’ve been able to really take forward and build on, those coach sessions.

Father 1

The four children of the fathers who took part in courses A and B were all aged < 7 years. Researchers and facilitators observed that some of the elements of the children’s workbook were too advanced for the younger children, but the younger children still engaged well with the facilitators. One father commented that they really appreciated that they were actively involved in the programme:

The reward system I think for my two children, being slightly younger. They really enjoyed each week filling up their chart and going off then and feeling like there was a real value to completing the tasks and completing the kind of homework elements, that they came back next week ready and eager to be able to show what they’ve done and earn their next sticker on their chart . . . They loved trying a new sport and bits like that, but I think they also enjoyed having a, yeah, having a responsibility and a specific role within the process that they knew that they had targets that they had to get Daddy to do and for them they really enjoyed that.

Father 1

The timing of sessions was a challenge, and was the main reason that the non-attenders could not complete the programme:

Just the timing yeah, I just I couldn’t get away from work early enough to get to [venue name] for five.

Father 3

Another participant who was not interviewed was also not able to complete the course for the same reason: it clashed with other evening commitments. It was also noted that the evening sessions were late for young children, although the challenge of finding a suitable time was acknowledged:

Timing, again having younger children was a bit of a challenge as the kind of sessions didn’t tend to finish till quarter to seven, seven o’clock and my children’s bedtime kind of starts about seven o’clock . . . it was a bit of a challenge but it was still knowing it was only 9 weeks and we’d planned in for that. But again, I don’t know how else it would have been done because if it started earlier I’d have struggled to feed them tea before we got there. And it felt like the hour and a half did just race by and I think if it was any shorter a session then we wouldn’t have got the same value from it for the two sections to work as well as they did. So there is, whilst it was a bit of a challenge finishing later, it was workable and I couldn’t offer a better solution than the solution that is.

Father 1

Neither of the participants could think of any significant negatives to the programme and most of the changes made to the session content ahead of phase 2 were based on researcher observations. One participant did mention that at times the PowerPoint presentation did not match the handbook (also identified by the researchers and the facilitators) and this was remedied for WP2. Similarly, the importance of the facilitators being comfortable with delivery and familiar with the materials from session 1 of the courses was important and highlighted the benefit of running the courses in phase 1b:

I think there was those first couple of weeks where it was just, it felt, yeah, that it was just going to be a bit of a presentation of literally what we were reading on the screen. But easy to see now that was just everybody getting used to the kind of programme but then once you going, no, I thoroughly enjoyed the sessions and enjoyed the discussion.

Father 1

Both participants spoke positively of lifestyle changes that they had made as a result of the programme, suggesting that the key messages of the programme were being delivered with impact. Both participants spoke about making more efforts to increase the amount of walking:

I’m moving throughout the day and more consciously choose to kind of go for a walk at lunchtime and just to get my steps up a bit.

Father 1

I’ve made good use of my fitness well app that the facilitator suggested and I’ve started looking after what I eat, how much I eat, when and planned my food intake as opposed to not doing it at all. And personally for me it’s helped, I’ve lost a bit of weight and it’s still coming down close to where it should be.

Father 2

One of the things that we’d started doing, doing Healthy Dads, from the challenges that we’re set was to walk more . . . once a week on the way home from school . . . we’ll go on a big long walk and go and find and do an adventure somewhere and that’s something the kids have really enjoyed and I’ve really valued, actually finding that time in the week . . . it’s become more of a tradition now that we do . . . and have really grown to value the time that we spend together doing these walks which has come, yeah, straight off the back of the Healthy Dads programme.

Father 1

Further monitoring of participant feedback for sessions were the weekly session feedback forms, which were completed at all but one session (in error, forms were not handed out at session 5) by the participants. The forms were well completed, suggesting that they were acceptable to the participants and were carried forward to be used in phase 2. The results of the feedback again highlighted that the participants rated the sessions highly (Tables 8 and 9).

Iterative intervention adaptations during delivery

Researchers attended and observed every session for phase 1b (courses A and B), often assisting with delivery as previously described. The first 4 weeks of the programme were delivered in course A before course B; therefore, it was possible to make changes and test these out in course B for the first four sessions. Researcher observations and experience of delivery, and facilitator feedback, formed the basis for much of the amendments made throughout the programme delivery. Facilitator feedback was obtained informally through discussions between the researchers and facilitators following each session and also in a formal facilitator interview. However, all but one of the facilitators who were interviewed post intervention had delivered courses for both phase 1b and phase 2. Therefore, when interviewed, they mostly spoke of their experiences of the programme as a whole, rather than separately by work package. Many of the findings from these interviews are presented in Chapter 6. One facilitator only presented phase 1b; some findings from his interview are presented here. The identification code to indicate their quotations are, for example, ‘P1b.B-FE1.M’, to denote the work package (phase 1b or 2) delivered, the site (A or B), section of session delivered (FE: father-only education), ID number (1) and the facilitators gender (M: male).

The main change for the father-only education sessions was to reduce the volume and complexity of information delivered, as these sessions were challenging to deliver for the facilitators and often ran over time, which meant that there was less time for the joint physical activity sessions. This was mainly picked up by researcher observations but also commented on by both a facilitator and a participant during their interviews:

There was a bit too much information and probably going into a little bit too much depth, I’d say, for the type of clientele that we get to the groups but then I do think you need a bit of a wide variety. I do feel that when we’re delivering the presentations that sometimes, we were rushing at times and yet we still ended up going over by quite a bit of time.

P1b.A-FE1.M

Sometimes, and this is when we kind of over-run the presentation part, time wise, when they had prepared some game and not always they have the chance to play with me during the activity part because we run out of time. So that’s what they [participant’s children] were sometimes slightly down about, but other than that, they were really happy, really enjoyed it.

Father 2

Some content of the session was also considered by researchers and facilitators to be unnecessarily complex for the audience. The facilitator drew on his experience of working in the community to consider the suitability of the materials:

. . . I think for this particular area, going back to what I said, I think it might have been a little bit too complex for some of the dads. In terms of the people that we see day to day with healthy lifestyles, I think some of them may have struggled to take in the information that we were working with and we were delivering to them. In terms of the parent that we saw, it was no problem for him.

P1b.A-FE1.M

Therefore, the research team simplified some sections to ensure that participants remained engaged with the programme. An example of this change is a component of the week-2 session, which asked participants to calculate their daily energy needs using maths equations. The materials were changed such that the participants’ daily energy needs were explained, but much of the calculation was completed for them and they were signposted to a website that could do the calculation for them in the future.

In general, the child-only sessions required little amendment. Small changes were made to the children’s handbook, mainly to make it simpler for completing, especially in the tasks that children were asked to select for participation with their fathers. The content of the physical activity sessions worked well and, similarly, required little amendment. The most pressing challenge was fitting the session into the allocated time slot, compounded by the father’s education sessions running over time.

Key learning points from phase 1b

While acknowledging the limitations of the small number of participants who attended the intervention and were interviewed, there were learning points for the delivery of phase 2. In summary, phase 1b helped to inform phase 2; the key findings are detailed in the following sections.

Data collected

As explained in Chapter 4, the findings from different data sources are integrated into each section of the results; therefore, for clarity, this section presents the availability and summary of data from the different sources used to inform the results section.

The feasibility of delivering an adapted Healthy Dads, Healthy Kids programme

The feasibility of recruitment and follow-up

Recruitment rates

Despite having a range of recruitment pathways, only 43 fathers and 61 children were recruited in WP2. Overall, 92 men expressed an interest in the study; most did not proceed to recruitment because of loss of interest or the research team being unable to make contact, six had too low a BMI and four did not have children in the correct age range. Further details are in Figure 4.

FIGURE 4.

Participant flow through HDHK-UK for fathers. a, One participant followed up by completing questionnaire only; b, lost to follow-up out of those participants who completed follow-up at month 3; c, 15 participants continued from the previous 17 who completed the follow-up at month 3 – two of them were not able to complete the 6-month follow-up appointments, but offered to send in measurements only. In addition, two participants returned from lost to follow-up at month 3; d, eight participants continued from the previous 10 who completed the follow-up at month 3 (one completed the questionnaire only at month 3 but completed the follow-up visit at month 6, and another completed follow-up visit at month 3 but changed to send measurement in only at month 6). In addition, two participants returned from lost to follow-up at month 3. Reproduced from Griffin et al. 113 © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/. Minor formatting changes have been made to this figure.

Reproduced from Griffin et al. 113 © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/. Minor formatting changes have been made to this figure.

The feasibility of a future definitive trial

Level of data completeness at 3 and 6 months

The level of data completion of the questionnaires by the fathers at 3 and 6 months was acceptable. Missing questionnaire data were highest for the IPAQ, for which a missing item can result in an inability to compute a continuous outcome measure. There was also a high level of missing data for fathers’ waist circumference, with many men preferring not to have this measured. The level of data completion is reported in detail in Appendix 8, Tables 40 and 41. The ability to collect the Strengths and Difficulties Questionnaire data at the 6-month follow-up for the eldest child is reported in Table 28; most of the missing data were due to loss to follow-up of participants, missing items were few.

We were able to collect the data required for a health economic analysis in a future full-scale RCT; the data completeness levels were good for the EQ-5D-5L and for the reports of health service utilisation (see Appendix 8, Tables 40 and 41).

Adverse events

There were no serious adverse events necessitating hospital admission or adverse events necessitating medical attention during the intervention. There were three minor events: two children had incidents in which they bumped their heads and one father felt unwell during the exercise component and stopped. He reported the next day that he felt better and had not sought medical attention.

Costs of programme delivery

We have estimated the costs of the HDHK-UK programme delivery (details are in Appendix 9, Tables 42–44). The costs exceeded those estimated and varied according to the site and provider. Using 2018 prices, the delivery model using Healthy Lifestyles staff and an independent physical activity coach cost a total of £1881 for the entire programme, excluding training. If take-up had been higher and the programme had included 15 families attending, then the cost per family would be £150. The marginal cost per family rises as the number of participating families falls; for example, the equivalent per-family cost for eight families participating would be £235. Appendix 9 describes the variance in these costs according to the design and provider of the programme.

Summary: the feasibility of trial data collection

Overall, the level of missing data from the participants at baseline and at follow-up was acceptable.

Introduction to discussion

In this section, we provide a summary and an interpretation of the main findings of the study; compare our findings with those of other studies, particularly the original reports of the HDHK study from Australia; discuss strengths and limitations; describe public involvement in the study; discuss the criteria for progression to a full trial; and provide recommendations for future research.

Summary of findings

Interpretation of these findings

We have reported challenges in bringing an effective intervention, the HDHK programme, from Australia and implementing it in socioeconomically deprived and ethnically diverse areas of the UK. Other interventions have failed to transfer across high-income settings with a failure to replicate the outcomes, such as the lack of effectiveness of an intervention to increase physical activity and diet in children,114,115 the lack of effectiveness of the Family Nurse Partnership in the UK,116 compared with its effectiveness in the USA,117–119 or the failure of breastfeeding peer support interventions in the UK, compared with other settings. 120

Although there have been many adaptations of health promotion activities to meet the needs of ethnic minority populations, Liu et al. 69 reported the findings of a systematic review in which it was possible to link effectiveness to the adaptations in only 9 out of 107 primary studies of adapted interventions. 69 Our adaptation aimed to produce an intervention that was acceptable to general multiethnic, socioeconomically diverse populations, not just one minority group. Methods of cultural adaptation generally focus on adapting an intervention that has been effective in the majority population to one homogenous minority ethnic group;85,121,122 this does not address the needs of the super-diverse populations of large cities. This is an area requiring further research. We used a typology of cultural adaptation,69 which included components that related both to the intervention adaptation and to ensuring that the research processes were also culturally acceptable. This was challenging to operationalise.

We had significant difficulties in recruiting overweight and obese men. A systematic review18 of what motivated men to participate in a weight management programme reported difficulties recruiting men to weight-loss trials. Trials of interventions to manage obesity in men are still relatively sparse,18 compared with the literature for weight loss overall, in which women are the predominant participants. 123,124 No recent trials have specifically targeted ethnic minority males, who make up only 1.8% of the total participants of US studies of weight management interventions. 123 However, weight management trials in men have previously reported findings of effectiveness in the context of work places21,125 and football supporters. 20 There is a need to explore alternative settings for delivery, as the reach of interventions in sports venues and workplaces is not clear18 and many men will be excluded from interventions that recruit through these routes through unemployment or through financial circumstances making attendance at sports events less likely. We hoped that trying to recruit overweight and obese men through other routes that involved their children would be an inclusive recruitment method. Consistent with previous research,126 we found that active recruitment strategies whereby we engaged with the fathers were more successful than passive advertising strategies or recruitment via leaflets given to children or mothers. A potential explanation may have been the sensitivity of inviting an overweight partner/father to the HDHK programme, which was raised by our PPI group. Despite our attempts to brand the programme as being about healthy family lifestyles and quality time between fathers and their children, we did have to mention the lower BMI threshold on the promotional leaflet, which may have been a barrier. Other potential barriers may have been the need for attendance at a recruitment session either at home or a convenient venue, and the challenges of finding a convenient time for the father and child(ren). Recruitment to group-based interventions can be difficult owing to the accessibility and comfort of the venue, the meanings attributed to the setting and the sociodemographic characteristics of the participants and facilitators of a group. 127

Once recruited, 31% of the participants who were randomised to the intervention group did not commence the programme. This is consistent with other RCTs of group-based weight management, but much higher than the Australian HDHK evaluation (2%). 128 In other contexts, such as cardiac rehabilitation, which is offered after a cardiac event, uptake to the group-based rehabilitation is low, with only 51% of eligible people taking up the programme in the UK. 129 Attrition from the intervention was high: of those who attended a session, 75% attended five or more, but only 45% attended seven or more sessions, which may reflect issues of convenience and timing. Participant attrition in HDHK-UK was high, with only 63% of participants followed up at 6 months. Intervention participants who attended only one or two sessions had the lowest follow-up rates at 3 months (20%; 1/5); this might be as a result of the group climate or group cohesiveness, which have been associated with increased attendance and self-efficacy in exercise classes. 130 High levels of attrition have also been seen in a trial of children’s weight management in a similar population;53 in others trials of child weight management,131,132 trials of men’s weight management18,19 and weight management interventions overall;124 and in trials of physical activity promotion in socioeconomically disadvantaged communities. 133 However, the majority of the research on behaviour change interventions in people from black and ethnic minority groups and from socioeconomically disadvantaged communities comes from research conducted in the USA, with a predominance of research in African American and Hispanic populations133 and conducted in faith-based settings, which may not be transferable to a UK context.

One challenge we faced was that the research funding for the study was from a call to address men’s weight management. Other studies have reported that parents are more likely to enrol on programmes that focus on a healthy lifestyle, rather than on weight loss. 134 Although the HDHK programme in Australia was designed as a weight management programme, in its community roll-out, it used a more inclusive approach and focused on family healthy lifestyle practices. Our public involvement panel reinforced the difficulty and power imbalance in families, whereby a child or partner might suggest their father/partner joined the programme. Although our initial flyer focused on lifestyle change and fun physical activities with their children, we had eligibility criteria of a high BMI value or large waist circumference. We had interest from fathers who were interested in taking part, but were not overweight. Any future roll-out of the HDHK programme in the UK would be better placed if an inclusive approach is taken with fathers/father figures without a weight eligibility criterion.

The findings from the qualitative interviews and feedback from the fathers who attended the programme support those reported by Robertson et al. 18 The men liked the physical activity component and the interactions within the group. The measures of acceptability of the HDHK-UK intervention fulfil a number of the component constructs of acceptability as described by Sekhon et al. 135 Fathers described their feelings about the intervention (affective attitude), the burden, the intervention coherence, opportunity costs, the intervention’s perceived effectiveness and their self-efficacy in performing the behaviours. 135

Costs of programme delivery

The aims of the feasibility study in relation to health economics were to determine whether or not the quality-of-life and well-being questionnaires were acceptable and completed with sufficient completeness to determine utility and capability scores in fathers and children, and to collect data on the costs of delivering the programme and on health-care resource utilisation. The feasibility study highlighted the differential costs depending on delivery and setting. Per-family costs (dependent on the number of families per group) ranged substantially from £150 (15 families) to £235 (8 families), excluding training. In any future definitive trial, it would be important to collect data on the costs to the participants in terms of time, as well as financial costs, to inform a wider perspective for a health economic analysis. For the feasibility study, we were trying to minimise questionnaire burden.

Furthermore, for the economic evaluation, although the generic utility-based instruments might not be as sensitive to change as weight-focused quality-of-life measures, they are a generic measure of outcome and therefore relevant for informing resource allocation decisions across different sectors and disease areas. For a comprehensive economic evaluation alongside a weight-loss trial, we would recommend the use of utility instruments such as the EuroQol-5 Dimensions (EQ-5D) and the CHU-9D to place the analysis in this broader context, as well as more specific weight-focused instruments to facilitate a cost-effectiveness analysis.

Comparison with the Australian Healthy Dads, Healthy Kids research findings

The Australian RCTs of the HDHK programme had positive outcomes, reporting a mean difference in weight loss in the fathers of 3.4 kg (95% CI 2.1 kg to 4.7 kg) in favour of the intervention at 14 weeks, compared with a wait-list control in a community trial,45 and a mean weight loss in the fathers of 7.6 kg (95% CI 6.0 kg to 9.2 kg) in an efficacy trial at the 6-month follow-up. 46 In this section, we explore the differences between the delivery and context of the Australian trials and HDHK-UK programme (Table 29). The efficacy trial was delivered by Philip Morgan, who developed the programme, in a university setting with highly engaged participants; thus, the findings are unlikely to be replicable. Therefore, we have compared the findings of the HDHK-UK study with that of the randomised controlled community trial. 45 Overall weight loss in the intervention group of the Australian HDHK study was 3.3 kg (95% CI 2.4 kg to 4.3 kg) at the 14-week follow-up, similar to the 2.9 kg (95% CI 0.6 kg to 5.1 kg) at the 6-month follow-up in our UK study.

Key differences relate to the setting and context: the UK programmes were delivered in a public health context in socioeconomically disadvantaged localities and among populations with high ethnic diversity. The populations invited to the Australian HDHK programme were more sociodemographically heterogeneous, with people from high and low socioeconomic circumstances and a large proportion doing shift work. In our UK sample, 74.4% lived in localities in the two most disadvantaged quintiles of socioeconomic deprivation, compared with 3% of the Australian sample being in the lowest two quintiles of socioeconomic status. The Australian programme was funded by an industry partner and community fund, whereas the UK intervention was funded by the local authority public health budget, which was resource constrained.

The training in the UK took a ‘train-the-trainer’ approach, with training manuals and additional video clips of the physical activity sessions and activities for facilitators to watch before the sessions. Owing to difficulties in recruitment, planning training and delivery issues, some of the facilitators were trained several months prior to the start of the programme, whereas others had a few hours of training then support for the early weeks of delivery. By contrast, all of the Australian facilitators were trained by PM 2–3 weeks before the start of the programme. This may have affected the fidelity and style of delivery in the UK.

The UK study randomised participants to the HDHK programme or to a control group with a minimal intervention with follow-up at 6 months, whereas the Australian programme had a wait-list control and a follow-up at 14 weeks. The wait-list control meant that the trial could be promoted as offering a fun programme for children and their fathers, whereas we could not promote the HDHK programme, as some of the participants would not receive the intervention. This made the first approach to recruitment substantially more difficult.

Recruitment in the UK was a huge challenge, with difficulties engaging with schools and other organisations to gain access to fathers of primary school-aged children. Schools had a large number of competing demands and communication was slow. In addition, despite schools being identified in the cultural adaptation as an ideal place for the programmes to take place, constraints in opening hours and availability of school halls made it difficult to align availability with the times when fathers could manage to attend sessions after they had finished work and commuted through a very congested urban area. Once we had interest from schools, we invited their teachers to the HDHK training; however, there was no interest from teachers in the schools. Therefore, we sought alternative people to deliver the programme. It became apparent that a high degree of skill was required to deliver the content of the fathers-only educational sessions and the physical activity component. The HDHK programme in Australia was delivered by qualified teachers; a male facilitator (who was a father) led the fathers-only education session. Furthermore, continuity of facilitators was maintained. We identified lower satisfaction in the group for which we were unable to have a consistent facilitator and we also had feedback from the male facilitators of two of the groups that the interactions between the participants changed when a female observer attended the sessions. However, previous research has not identified that the sex of the person delivering a weight loss intervention to men affected men’s outcomes. 18 During our adaptation phase, phase 1a, participants highlighted the importance of having someone who is a father himself delivering the fathers-only educational sessions. This was something that we were unable to accommodate.

There were differences in delivery in terms of the time of the year, with the UK programme taking place over the winter and the Australian programme taking place over summer, when evenings are brighter. Feedback from fathers in our feasibility study highlighted the dark evenings and poor weather as deterring attendance.

The HDHK programme had also changed by the time we adapted it. The subsequent community roll-out in Australia had extended the programme to nine sessions and included mothers for one session; this longer duration may have affected engagement with the UK programme. The small number of attendees at each session in the UK meant that the programme was delivered in a more participatory and discursive manner than was the case in Australia, where the groups were much larger.

These differences provide some insights into how the programme would be best delivered in the UK context, as discussed below.

Strengths and limitations

This study had many strengths. The intervention adaptation process was multifaceted and drew on a typology of cultural adaptation. 69 We also drew on other family-based programmes that were being developed in a similar UK locality53 and a new family-based programme developed by the Australian team for fathers and their daughters. 67 We did not find any evidence from our qualitative interviews and focus groups in phase 1a that the underpinning theories of the HDHK programme were not relevant to our population. We did identify a number of surface and deep structural adaptations, which were implemented and then further tested in phase 1b, the uncontrolled feasibility trial. We undertook two iterations of the feasibility trial, so we were able to test recruitment and delivery strategies, as well as content acceptability, during the uncontrolled trial (phase 1b). In addition, we included a robust process evaluation with data from qualitative interviews, observations, feedback after sessions from both facilitators and participants alongside both the uncontrolled feasibility trial (phase 1b) and the randomised feasibility trial (phase 2).

However, the study had limitations. The small numbers of participants attending the programme in phase 1b means that we may not have gained as much learning about the acceptability of the programme and delivery as would have been optimal. If there had not been challenges with venues and staff to deliver the programme, we may have reached different conclusions about the acceptability and adaptations needed following phase 1b. Many of the limitations were as a result of challenges we faced, particularly the difficulty in recruiting overweight fathers from ethnically diverse, socioeconomically disadvantaged communities to a group-based healthy lifestyles programme. The study was made more challenging by the need for the intervention to be funded by the local authority, which has responsibility for delivering public health interventions. However, weight management is not one of the mandated activities that local authorities have to deliver and the context of the study period was a financial tightening of public health activities in local authorities. One of the planned partner local authorities close to the university ceased to offer adult weight management, and so was unable to support the intervention. This resulted in a considerable increase in travel costs and time to locate the study in other sites, which may have affected our recruitment and delivery challenges. We had less local knowledge about these areas and had to rely on our local authority partners to help identify delivery sites. Financial constraints also led to the need to use the staff employed by one of the local authorities rather than select from a wider pool of potential HDHK programme facilitators, as these staff were already paid and there were limited funds available to fund the intervention costs. During the delivery of the HDHK-UK programme, one of the local authorities had a reorganisation of their public health department, which resulted in loss of staff who were trained to deliver the programme. Staff changes were also an issue in the coaching organisation; indeed, none of the nine facilitators trained in January 2016 by the Fatherhood Institute were in the same post or organisation 12 months after training. Consequently, our training needed to be more flexible and ongoing to cope with staff changes, which may have affected fidelity.

Another issue that may have affected fidelity in the delivery of the programme to the children was that many of the children failed to bring their handbook with them to sessions. In addition, owing to delays in starting, we ended up delivering the programmes over the winter, which was a particularly harsh UK winter (2017–18). This contrasts with delivery of the HDHK programmes in Australia that have all been delivered over the summer months. Although our adaptation work directed us towards delivery in primary schools, we found primary schools challenging to work with: communication was slow, as our link was sometimes classroom-based with limited time to respond to e-mail requests; and permissions, for example to speak to parents at school pick-up time, often required us to go up through a chain of people to gain approval.

We had planned to interview the children as well as the fathers at the 3-month follow-up point of the feasibility trial, but many of the children were too young to take part in an interview, so we do not have feedback directly from the children. Participant attrition was high, and was higher in the intervention group than in the comparison group; we can speculate that families that did not enjoy or perceive benefit from the programme were less likely to attend follow-up. With the small participant numbers, we have been careful to report data completion rates and, in keeping with good practice for feasibility studies, not to make any comparisons between the study arms.

Lessons in delivery of the Healthy Dads, Healthy Kids programme in the UK

We have identified a number of issues relating to the delivery of the programme that would need to be addressed to successfully deliver the HDHK programme in a UK community context:

• The facilitators need to have been trained in sport and fitness coaching and have the ability to deliver an educational session.

• The timing of the sessions should avoid the evenings in winter and should include the option of weekend daytime sessions, as these were popular.

• Children in the UK start school younger than in Australia and we found that the 4-year-olds struggled with the structure of the sessions; the programme is probably best suited to children aged 5–11 years.

• To deliver the fathers-educational sessions in a discursive and participatory manner, the number of slides needs to be reduced further to keep this part to 30 minutes.

• The focus should be on family lifestyle change, benefits to the children and the father–child relationship, and fun, not weight management of the fathers.

• Given the high turnover of staff in the organisations that provided facilitators, any future intervention delivery needs to plan repeated training. Consideration should be given to the development of a training video to support implementation.

Consideration of progression to a trial to assess the effectiveness and cost-effectiveness of the Healthy Dads, Healthy Kids programme in the UK context

In the HDHK-UK study protocol, we specified that we would consider the following factors when making the decision to proceed to a full trial of the effectiveness and cost-effectiveness of the HDHK programme in the UK:

• a process evaluation suggests that the intervention is acceptable to a majority of fathers and families from differing BAME and socioeconomic backgrounds

• randomisation occurs and > 80% of those assessed accept randomisation

• recruitment of at least 68 out of the planned 90 fathers (75%) within the 4-month time frame

• intervention implemented with fidelity in 75% of observations

• attendance – 70% attending at least five out of nine of the planned sessions

• > 70% follow-up at 3 and 6 months

• mean weight loss in the intervention arm of ≥ 3 kg.

There were high levels of acceptability among those who attended the programme; however, only 69% (20/29) of the fathers allocated to the HDHK-UK programme attended at least once. Participants who attended reported changes to their own and their family’s dietary and physical activity. All of the fathers who were assessed and eligible were randomised and we delivered the intervention achieving the acceptable level of fidelity. However, our challenges to delivery of the programme in the current UK public health context were as follows: low recruitment rate of only 43 of the planned 90 fathers and high attrition with only 63% follow-up at 6 months. These suggest that, at present, it would not be feasible to progress to a full-scale trial of the effectiveness and cost-effectiveness of the HDHK programme in the UK. Although 75% of fathers who attended at least one HDHK session ‘completed’ (i.e. attended at least five of the nine sessions) the programme, overall, only 52% of the fathers randomised to the intervention completed the programme. Mean weight loss in the intervention arm was 2.9 kg (95% CI 0.6 kg to 5.1 kg) at the 6-month follow-up, but based on the 25 (58%) participants who provided weight data at this follow-up point.

However, the programme may be feasible in a different context. The randomisation to a control group made the recruitment more difficult and the comparison to a wait-list control may well have enhanced our recruitment, as we could have ‘sold’ the potential benefits of the HDHK programme, as seen in the Australian studies. Recruitment and delivery through an organisation such as a professional sports club’s community arm would be more feasible and would remove the delivery challenges, but the programme is unlikely to be funded by such a club in the current financial climate.

Patient and public involvement in the study

In this section, we describe PPI in the HDHK-UK study, using the Guidance for Reporting Involvement of Patients and the Public 2 (GRIPP2)-Short Form as a guide to content. 136 The aims of PPI and a brief description of the methods used are described in Chapter 2.

Research recommendations

Given that we did not meet the progression criteria for a future definitive RCT, we do not recommend a RCT of HDHK-UK for men’s weight loss in a community context in this specific UK context at present. However, we have the following areas that merit further research:

• research to explore the optimal ways to engage fathers from ethnically diverse, socioeconomically deprived populations in research

• an evaluation of the HDHK programme outside the context of weight management

• research into the best methods to recruit men to trials of weight management interventions

• research into the effect on recruitment and generalisability of public health interventions with a wait-list control compared with a no/minimal intervention control.

Conclusions

Men have high rates of overweight and obesity in the UK and in many other countries internationally. Although there is a need for systems approaches to tackling obesity through social, economic, political and structural environments,137–139 there is also a need for individualised approaches to supporting weight management. The evidence base for effective interventions is limited and we sought to address this gap in the literature by evaluating the feasibility of adapting a successful programme from Australia for fathers and their children aged 4–11 years to the UK context.

The randomised feasibility trial and process evaluation showed that, although well received and enjoyed, it was not feasible to deliver the HDHK programme to overweight and obese fathers in ethnically diverse, socioeconomically deprived communities in the UK in the current context. The lack of feasibility was largely due to implementation issues and our failure to recruit overweight and obese fathers to the study. Other challenges related to the relatively low retention rate at follow-up and high attrition from the intervention. Among those who attended the programme, there was a good completion rate and positive feedback about the programme from the fathers. We cannot comment on the feasibility of recruiting to the study outside the context of a men’s weight management intervention.

Contributions of authors

Kate Jolly (https://orcid.org/0000-0002-6224-2115) (Professor of Public Health and Primary Care) was the principal investigator, leading the study from design to delivery, and wrote the study report.

Tania Griffin (https://orcid.org/0000-0003-0146-4440) (Research Fellow) was the study co-ordinator for 14 months (July 2017–September 2018) and was a member of the study management team. She oversaw the delivery of phase 1b and the set-up and delivery of phase 2, and led the writing of Chapters 4–6.

Manbinder Sidhu (https://orcid.org/0000-0001-5663-107X) (Research Fellow) was the study co-ordinator from the start of the study to July 2017. He led phase 1a, the cultural adaptation, and the set-up of phase 2. He led the writing of Chapter 3.

Peymane Adab (https://orcid.org/0000-0001-9087-3945) (Professor of Chronic Disease Epidemiology and Public Health) was a co-investigator and contributed to the study design and interpretation of findings.

Adrienne Burgess (https://orcid.org/0000-0003-0965-365X) (Joint Chief Executive and Head of Research at the Fatherhood Institute) was a co-investigator and contributed to the study design, advised about recruitment of fathers, and contributed to the adaptation of the original HDHK materials and to the interpretation of findings.

Clare Collins (https://orcid.org/0000-0003-3298-756X) (Professor of Nutrition and Dietetics) was a co-investigator and contributed to the study design and collection of dietary data.

Amanda Daley (https://orcid.org/0000-0002-4866-8726) (Professor of Behavioural Medicine) was a co-investigator and contributed to the study design and interpretation of findings.

Andrew Entwistle (https://orcid.org/0000-0001-9745-3556) (Public Member) was a co-investigator, provided a PPI perspective and contributed to the Plain English summary.

Emma Frew (https://orcid.org/0000-0002-5462-1158) (Reader in Health Economics) was a co-investigator, contributed to the study design and interpretation of findings and advised on the health economic data collection.

Pollyanna Hardy (https://orcid.org/0000-0003-2937-8368) (Senior Statistician) advised on the statistical analysis and contributed to the interpretation of findings.

Kiya Hurley (https://orcid.org/0000-0002-5084-5410) (Research Fellow) led the physical activity accelerometry data analysis, contributed to study management and undertook qualitative interviews in phase 2.

Laura Jones (https://orcid.org/0000-0002-4018-3855) (Senior Lecturer in Qualitative and Mixed-Methods Applied Health Research) oversaw the qualitative components, was a co-investigator and contributed to the study design and interpretation of findings.

Eleanor McGee (https://orcid.org/0000-0002-8497-9927) (Dietitian, Birmingham Community Healthcare Trust, NHS) was a co-investigator, and contributed to the study design and interpretation of findings.

Miranda Pallan (https://orcid.org/0000-0002-2868-4892) (Senior Lecturer in Public Health) was a co-investigator. She led the CHANGE study and advised on the cultural adaptation, and contributed to the study design and interpretation of findings.

Yongzhong Sun (https://orcid.org/0000-0003-0659-9811) (Statistician) developed the statistical analysis plan, undertook the statistical analysis and contributed to the interpretation of findings.

Myles Young (https://orcid.org/0000-0001-7670-9196) (Research Fellow) was a co-investigator, he advised on implementation and contributed to the study design and interpretation of findings.

Philip Morgan (https://orcid.org/0000-0002-5632-8529) (Professor of Education) designed the original HDHK programme. He was a co-investigator, and contributed to the study design, delivered training materials, advised on implementation and contributed to interpretation of findings.

All authors read and approved the final version of the report.

Publications

Griffin T, Hurley K, Sidhu M, Adab P, Pallan M, Daley A, et al. Recruitment and Delivery of a Weight Management Programme for Fathers of Primary School Aged Children: Challenges Experienced in the Healthy Dads, Healthy Kids-UK Feasibility Study. 5th UK Congress on Obesity, Newcastle, 6–7 September 2018.

Griffin T, Hurley K, Sidhu M, Jones L, Morgan P, Adab P, et al. A Weight Management Programme for Fathers of Primary School Aged Children: Qualitative Findings from Healthy Dads, Healthy Kids-UK. 5th UK Congress on Obesity, Newcastle, 6–7 September 2018.

Jolly K, Griffin T, Sidhu M, Hurley K, Adab P, Burgess A, et al. Healthy Dads, Healthy Kids. Adapting an Australian Group Based Weight Management Programme for Fathers of Young Children in a UK setting; a Feasibility Study. UK Society for Behavioural Medicine Annual Meeting, Birmingham, 13 December 2018.

Griffin T, Sun Y, Sidhu M, Adab P, Burgess A, Collins C, et al. Healthy Dads, Healthy Kids UK, a weight management programme for fathers: feasibility RCT. BMJ Open 2019;9:e033534.

Data-sharing statement

All data are available on request from the corresponding author.

Disclaimers

This report presents independent research funded by the National Institute for Health Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, NETSCC, the PHR programme or the Department of Health and Social Care. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, NETSCC, the PHR programme or the Department of Health and Social Care.