Development and evaluation of an intervention for the prevention of childhood obesity in a multiethnic population: the Born in Bradford applied research programme

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Description of ethnic classification

Born in Bradford is a multiethnic cohort consisting of families from around the world. However, the main ethnic groups are of South Asian origin (Pakistani, Bangladeshi and Indian) and white British origin. The large majority of the South Asian-origin families are of Pakistani origin. Much research into South Asian health and well-being combines what are often very heterogeneous ethnic groups. A strength of Born in Bradford is the homogeneity of the largest ethnic group of Pakistani origin. Methodologically and statistically, the focus of much of the work in the programme has been on Pakistani and white British comparisons. For completeness some of the analyses include a third category of ‘other’ ethnicities, which includes non-Pakistani and non-white British children. When we refer to the terms ‘South Asian’ and ‘Pakistani’ we are referring to families of South Asian or Pakistani origin who have been born either in the UK or in South Asia or Pakistan.

SYNOPSIS

Childhood obesity is a major global public health threat. 1,2 Although overweight and obesity prevalence in some groups of children may be flattening or decreasing,3–5 overall prevalence remains high, particularly in children from minority ethnic groups. 6,7 Evidence from the UK and the USA shows that the prevalence of overweight and obesity in preschool children is > 33%. 8–10 Obesity acquired in childhood has been shown to persist into adulthood with over half of obese children growing up to be obese adults. 11 It is estimated that the direct cost of obesity to the NHS will be £2B by 2030 if the current trends continue. 12 The 2007 Foresight report13 estimated that the direct and indirect costs of child and adult obesity would rise to £27B by 2015.

Childhood obesity has a major impact on health and well-being in childhood and through to adult life. 14–17 Obese children experience poor health-related quality of life and low self-esteem18 and, although the contribution of obesity towards the risk of negative health outcomes such as cardiovascular disease (CVD) and diabetes is complex, evidence suggests a consistent positive association. 19,20

Children of South Asian origin are at particular risk of overweight and obesity, demonstrating greater central adiposity and insulin resistance than their European-origin counterparts for a given body mass index (BMI). 21–24 Evidence suggests that this fat–thin insulin-resistant phenotype is present at birth and that pregnancy is an important window of opportunity for obesity prevention. 25,26 The adoption of Western urban lifestyles that result from migration to the UK has the potential to increase the risk of rapid postnatal growth and obesity contributing to the higher risks of diabetes and CVD.

There is emerging evidence that early life environments are important in the aetiology of obesity. 27 Maternal gestational weight gain and gestational glucose metabolism, together with greater birthweight and rapid postnatal growth, are all associated with later obesity, although it is unclear if this is driven by causal mechanisms. 28–32 Infant weight gain is consistently associated with subsequent risk of childhood and adult obesity and this risk is particularly high for infants with very rapid weight gain [> 1.33 standard deviation score (SDS) or two centile band crossings]. 33 However, it is the social, behavioural and environmental influences on childhood obesity that offer most potential for modification of factors influencing obesity. 34–38 A recent review of systematic reviews of early determinants of obesity identified the following factors associated with an increased risk of childhood obesity: maternal smoking, short sleep duration, < 30 minutes of daily physical activity, consumption of sugar-sweetened drinks, screen viewing and parental feeding practices. 39 Importantly, however, the evidence of causality is not clear. 40 Thus, although reinforcement of positive health interventions such as breastfeeding should be encouraged, there is still much to learn regarding the impact it has on childhood obesity.

Patient and public involvement

The BiB1000 study has benefited from extensive experience of patient and public involvement within the Bradford Institute for Health Research. This has included the use of a panel of 10 people representing the local patient community who meet regularly (3-monthly) to participate in all stages of the research process, including identifying priorities, helping to write lay summaries, reviewing methodology and supporting translational work. Panel members work in pairs to provide peer support but also meet collectively to discuss general and specific issues. The BiB study has a strong focus on wider community engagement, with regular newsletters, birthday cards, picnics and art exhibitions. One of the great strengths of the study is the close involvement of the photographer Ian Beesley and the poet Ian McMillan, whose work is featured here and in the appendices of this report.

www.borninbradford.nhs.uk

@BiBresearch (Twitter, Inc., San Francisco, CA, USA)

Born in Bradford (Facebook, Inc., Menlo Park, CA, USA) (www.facebook.com/BornInBradford/)

Recruitment and data collection for the BiB1000 cohort to investigate childhood obesity

The BiB1000 study was established to help enable a deep and extensive understanding of the predictors of and influences on health-related behaviours and to develop a culturally specific obesity prevention intervention. Here we describe the methodology and characteristics of the study participants; this work has been published as a separate paper. 63

All mothers recruited to the full BiB study between August 2008 and March 2009 who had completed the baseline questionnaire were approached to take part in the BiB1000 study during their routine 26- to 28-week glucose tolerance test. Those not attending this appointment were approached elsewhere during routine hospital attendances. A sample size of 1080 was calculated based on the ability to detect a clinically significant difference in infant growth of 0.67 SDS (one centile band) in weight at age > 1 year. Based on data from the Cole UK charts,64 we needed a minimum sample of 36 participants in any analysis group for length and a minimum of 67 participants for weight (β = 0.80; α = 0.05). Stratification by gender and ethnicity meant that we required a minimal sample of 280 at the completion of the preschool study. Allowing for a 5% annual attrition rate, we therefore required a total sample of 1080 births. However, to account for the higher anticipated attrition rate in a deprived multiethnic population, the plan was to oversample the population by up to 60%. Ethical approval was obtained from the Bradford Research Ethics Committee (reference number 07/H1302/112) and all participants provided written informed consent prior to inclusion in the research.

Bilingual study administrators who were trained in anthropometry collected baseline information from mothers using a structured questionnaire in the home, at hospital-based clinics and at local children’s centres. Participants were followed up at 6, 12, 18, 24 and 36 months.

The questionnaire measures included were selected based on hypothesised correlations with exposures and childhood obesity. As this was an exploratory study in a largely untested population, many of these hypotheses were driven by a combination of evidence from ‘similar’ populations in the literature and agreement by the scientific and clinical teams. Baseline data collection for the BiB study was pilot tested with a group of expectant mothers in the Bradford Royal Infirmary Maternity Unit for clarity, duration and acceptability. Except for assessment of dietary intake in infants, additional follow-up measures were not piloted in advance of data collection. However, their acceptability was determined within the BiB1000 cohort and amended as appropriate. The intended food frequency questionnaire for infants was pilot tested in children’s centres and this led to slight modifications to the clarification of items to ensure that foods were culturally representative (e.g. chapattis included within bread products).

Infant weight was measured at birth by midwives and infant head circumference, mid-upper arm circumference, abdominal circumference, subscapular skin fold and triceps skin fold were measured within the first 24 hours following delivery by paediatricians and midwives who were trained in measurement techniques according to written guidelines.

Postnatal measures of infant weight, length, head circumference and abdominal circumference were collected as part of routine practice by health visiting teams. Additional measures of weight, length, head circumference, abdominal circumference and skinfolds were taken by specially trained BiB1000 study health workers at follow-up visits.

Maternal weight was measured at all assessments, maternal height was measured at baseline and BMI was derived from the antenatal booking weight (at ≈12 weeks of pregnancy) and baseline height.

The majority of the demographic data were obtained using structured questionnaires. Items were generated and modified from the Millennium cohort study,65 Growing up in Australia,66 the 2001 census67 and the European Prospective Investigation into Cancer and Nutrition (EPIC)68 questionnaires.

Behavioural measures were collected as part of the structured administered follow-up questionnaires, including feeding style and practices, parental and infant diet, mental health, parental and infant activity, sleep patterns, home food availability, parenting practices and other health behaviours (e.g. smoking, alcohol consumption). Validated questionnaires were used when available, although appropriate ethnic modifications were made and tested using expertise within Bradford (e.g. diet questionnaires were modified based on 24-hour recall data collected from parents in Bradford alongside input from Bradford dieticians).

A full set of questionnaires used for all follow-up assessments can be found on our website [see www.borninbradford.nhs.uk/research-scientific/general-study-documentation-and-questionnaires-2/ (accessed 4 February 2016)].

Qualitative and objective methodologies were employed in subsamples to explore the lifestyles, behaviours and environments in this multiethnic population, including (1) food outlet mapping, (2) home food availability inventories, (3) a mealtime observation study of maternal feeding styles and (4) interviews with families. Further details of the methods and findings for each of these are provided in Investigation of social and environmental determinants of childhood obesity.

Out of 1916 eligible women, 1735 (91%) agreed to take part in the study. Of these, 28 mothers gave birth to twins. Descriptive statistics are provided here for singleton births only (n = 1707). In total, 77%, 75%, 74%, 70% and 70% of participants were followed up at 6, 12, 18, 24 and 36 months respectively; 47% of participants completed all of the assessments to date, with 17% (n = 294) formally withdrawing from the research. Participants who could not be contacted (or when the visit could not be scheduled) were not considered to be lost to follow-up unless a withdrawal form had been completed (i.e. withdrawal of consent, death or change of residence outside the area). Thus, in some instances, data are missing at one time point but are available at subsequent visits. The greatest factor that impacted on attrition rates was the inability to make contact with participants to book appointments.

The characteristics of the BIB1000 cohort were similar to those of the full BIB cohort,62 with a similar distribution of age, marital status and parity. Overall, 38% of women were of white British origin and 47% were of Pakistani origin; 41% of Pakistani women were born in the UK and, of the remainder who were born elsewhere, 24% moved to the UK before the age of 18 years. Around 20% of the sample questionnaires were administered in languages other than English, reflecting this migration pattern. Demographic differences by ethnicity within the BiB1000 cohort were also observed, with white British mothers tending to be younger, educated to a lower level and less likely to be married or cohabiting and having fewer children than mothers from other ethnic groups. More than 20% of Pakistani women had more than three children prior to the birth of the study infant. Correspondingly, household size for South Asian women, especially Pakistani women, was greater than that for other ethnicities. Infant gender, gestational age and proportion of preterm infants were similar between ethnic groups. Similarities were also observed for the mode of delivery and the proportion of stillbirths. Over 35% of white British women reported smoking during pregnancy compared with 4% and 3% of women of Pakistani and ‘other’ South Asian origins respectively. The proportion of women with gestational diabetes was greatest in the South Asian ethnic group, with a 10.5% prevalence in Pakistani women compared with a 5.5% prevalence in white British women.

Longitudinal data collection from the BiB1000 birth cohort has provided a sample for the NIHR programme to develop a deep and extensive understanding of the predictors and influences of health-related behaviours to help develop feasible and appropriate culturally specific intervention(s) for the prevention of childhood obesity. This was facilitated by experienced, enthusiastic, multilingual data collection staff. A unique quality of this cohort is its ethnic composition, with successful recruitment of approximately 50% of women from South Asian origin and a representative sample of women from across the socioeconomic groups within Bradford.

Development of a mobile phone app to predict childhood obesity73

Innovative strategies to identify infants at the greatest risk of childhood obesity are necessary for the prevention of obesity. We present the development of a practical mobile phone app (Figure 1) that can be used for a wide range of ages (4.5–13.5 months) in infancy when growth monitoring is part of routine health care. 81 The app requires information on a baby’s sex, date of birth, birthweight and current weight and users can optionally add maternal height and weight (to calculate BMI). We chose not to include ethnicity and gestational age because, although they were significant predictors, neither of these factors was significant in the internal and external validity analyses. Furthermore, ethnicity in our sample was restricted to white British and South Asian ethnicities and it was felt that this would not reflect the ethnic diversity (or lack thereof) in many areas. Maternal BMI was a significant predictor in the 6- and 9-month equations but, again, this information may not be available and so we developed two sets of prediction equations so that the app would work whether or not maternal BMI was available, with a negligible effect on the model fit.

FIGURE 1.

The Healthy Infant Weight? app.

In the future the app could be developed to incorporate any number of other functionalities, such as plotting of growth measurements on a growth chart, geospatial mapping of an infant’s obesity risk score compared with those of his or her peers and administration of an obesity prevention programme for those infants identified as being at high risk.

Ethnic differences in obesity risk factors

Epidemiological evidence has highlighted the importance of a number of exposures in pregnancy and early life that are associated with the development of obesity in childhood. In this study we investigated ethnic differences in five early-life risk factors for childhood obesity that are modifiable and can be targeted in future interventions. The risk factors considered were (1) breastfeeding, (2) infant diet, (3) infant sleep, (4) physical activity and (5) parenting style. The work on breastfeeding and parenting style has been published in two separate papers;82,83 the full reports for the other risk factors are presented in Appendix 1.

Early risk factors for childhood obesity

In the last section we described ethnic differences in five early-life risk factors for childhood obesity. Here, we investigate the association between several early-life modifiable risk factors for childhood obesity and infant BMI at 3 years of age. This work has been published as a separate paper. 92

It is important to understand whether or not modifiable characteristics are related to BMI in infancy to ensure that appropriate interventions are developed to promote maintenance of healthy BMI levels into mid-childhood, when important relationships to future coronary heart disease risk emerge. Furthermore, knowing whether or not associations differ between South Asian- and white European-origin infants is important in knowing whether or not interventions should target different risk factors in these groups to reduce the ethnic differences in risk. In this section we describe the differences in the prevalence of potentially modifiable risk factors for childhood obesity between infants of white British origin and infants of Pakistani origin and investigate the association between these risk factors and childhood BMI measured at 3 years of age. We also examine possible ethnic differences in associations between the risk factors and child BMI.

We found that the prevalence of early-life risk factors for a higher BMI differed between mothers of white British ethnicity and mothers of Pakistani ethnicity. White British mothers were more likely to smoke during pregnancy (28% vs. 4%), have a higher BMI (obese: 24% vs. 16%), breastfeed for a shorter duration (> 4 months: 20% vs. 29%) and wean earlier, whereas Pakistani mothers had a higher rate of gestational diabetes (14% vs. 7%) and were less active (sufficiently active: 26% vs. 57%). There were consistent associations between BMI z-score and maternal smoking [mean difference in BMI z-score 0.33, 95% confidence interval (CI) 0.13 to 0.53], maternal obesity (0.37, 0.19 to 0.55), indulgent feeding style (0.15, −0.06 to 0.36), lower parental warmth scores (0.21, 0.05 to 0.36) and higher parental hostility scores (0.17, 0.01 to 0.33). Associations with mean BMI were the same for white British and Pakistani infants, with the exception of breastfeeding duration. Although we did not have sufficient statistical power to examine ethnic differences in the associations of risk factors with relative risks of overweight/obesity, the similarity in the associations with mean BMI between the two ethnic groups suggests that differences on a binary scale are unlikely.

Consistent with other studies we found that children of mothers who smoked during pregnancy were more likely to have a higher BMI SDS and a greater risk of being overweight,40,93,94 as were infants of overweight and obese mothers. 28,93,95

We found that certain aspects of feeding and parenting style were associated with a child’s BMI. Caregivers with an ’indulgent’ feeding style had infants with a higher BMI SDS and who were more likely to be overweight; this is consistent with other studies. 96,97 Children of parents with less warm and more hostile parenting styles were more likely to be overweight. Different measures and constructs of parenting styles have been previously studied; however, evidence linking the specific domains analysed in the current study to childhood BMI is scarce, although some studies have looked at associations with dietary and activity behaviours. 98,99 Evidence suggests that children raised by authoritative parents had lower BMI levels than children raised with other styles. 98

In this study we did not find strong evidence of an association between gestational diabetes, age at weaning, infant energy intake, infant protein intake and infant sleep duration and infant mean BMI or risk of overweight at age 3 years, despite evidence of associations between these risk factors and BMI in other studies. 40,93,100–104 However, many of these studies were conducted in older age groups and in non-UK populations with different ethnic compositions to that of the BiB study population.

The main strength of this analysis is that we have considered several key modifiable risk factors that have been collected longitudinally during pregnancy and infancy in a multiethnic cohort. To our knowledge this is the first time that these risk factors have been studied in early infancy in infants of Pakistani origin. The limitations of the study are that it was undertaken in a single centre and so may lack generalisability. The questionnaire relied on self-report to collect information on risk factors and there may have been reporting or social desirability bias.

This work adds to the literature on the role of the early life environment and later childhood obesity and is useful in identifying suitable targets for obesity prevention interventions in infancy. It has highlighted key differences in early-life risk factors between white British and Pakistani mothers and so has highlighted the importance of cultural adaptation of interventions. It has also helped identify key modifiable risk factors to target in pregnancy and postnatally.

Systematic review of diet and physical activity interventions to prevent or treat obesity in South Asian children and adults

The previous workstreams identified the important modifiable determinants of obesity to form targets for intervention and identified key differences in the patterns of these risk factors by ethnicity and socioeconomic status. These findings highlight the need for culturally sensitive interventions to be developed.

We performed a systematic review to identify evidence that could inform the development of an obesity prevention intervention for pregnant South Asian women and their children aged < 6 years. This systematic review has been published105 and is freely available at www.mdpi.com/1660-4601/12/1/566 (accessed 1 February 2016).

The metabolic risks associated with obesity are greater for South Asian populations than for white or other ethnic groups and levels of obesity in childhood are known to track into adulthood. Tackling obesity in South Asian populations is therefore a high priority. The rationale for this systematic review was the suggestion that there may be a differential effect of diet and physical activity interventions in South Asian populations compared with populations of other ethnicities. The research territory of the present review is an emergent rather than a mature field of enquiry, but it is urgently needed. Thus, the aim of this systematic review and meta-analysis was to assess the effectiveness of diet and physical activity interventions to prevent or treat obesity in South Asian populations living in or outside South Asia and to describe the characteristics of effective interventions.

Systematic reviews of any type of lifestyle intervention, of any length of follow-up that reported any anthropometric measure for children or adults of South Asian ethnicity were included. There was no restriction on the type of comparator and RCTs, controlled clinical trials and before-and-after studies were included. A comprehensive search strategy was implemented in five electronic databases: Applied Social Sciences Index and Abstracts (ASSIA), Cochrane Controlled Trials Register (CCTR), EMBASE, MEDLINE and Social Sciences Citation Index. The search was limited to English-language abstracts published between January 2006 and January 2014. References were screened and data extraction and quality assessment were carried out by two reviewers. The results were presented as a narrative synthesis and meta-analyses were carried out.

In total, 29 studies were included, seven in children, 21 in adults and one in a mixed-age population. No studies in children aged < 6 years were identified. Sixteen studies were conducted in South Asia, 10 in Europe and three in the USA. Effective or promising interventions included physical activity interventions in South Asian men in Norway and in South Asian schoolchildren in the UK. A home-based, family-orientated diet and physical activity intervention improved obesity outcomes in South Asian adults in the UK when adjusted for baseline differences. Meta-analyses of interventions in children showed no significant differences between intervention and control groups for BMI or waist circumference. Meta-analyses of adult interventions showed a significant improvement in weight in data from two trials when adjusted for baseline differences (mean difference −1.82 kg, 95% CI −2.48 to −1.16 kg) and in unadjusted data from three trials following sensitivity analysis (mean difference −1.20 kg, 95% CI −2.23 to −0.17 kg). Meta-analyses of adult interventions showed no significant differences between intervention and control groups for BMI and waist circumference. Twenty of 24 intervention groups showed improvements in adult BMI from baseline to follow-up; the average improvement in high-quality studies (n = 7) ranged from 0.31 kg/m² to −0.8 kg/m². There was no evidence that interventions were more or less effective according to whether or not the intervention was set in South Asia or by socioeconomic status.

Meta-analysis of a limited number of controlled trials found an unclear picture of the effects of interventions on BMI for South Asian children. Meta-analyses of a limited number of controlled trials showed significant improvements in weight for adults but no significant differences in BMI and waist circumference. One high-quality study in South Asian children found that a school-based physical activity intervention that was delivered within the normal school day and which was culturally sensitive was effective. There was also evidence of culturally appropriate approaches to, and characteristics of, effective interventions in adults that we believe could be transferred and used to develop effective interventions in children.

Investigation of social and environmental determinants of childhood obesity

To further explore the impact of social and environmental factors on health we conducted a range of further focused studies. The aim was to understand how these factors might constitute determinants of childhood obesity, how they might vary according to mothers’ ethnicity and how they might be modified, with a view to informing any subsequent intervention. Specific areas of focus were parental attitudes to eating and infant growth, interactions that accompany mealtimes and the availability of certain foods in the home and in the neighbourhood. The work on food availability in the home and in the neighbourhood has been published in two separate papers;106,107 the full reports for the other topics are presented in Appendix 1.

Using intervention mapping to develop a culturally appropriate intervention to prevent childhood obesity: development of the Healthy and Active Parenting Programme for Early Years intervention

The previous workstreams provided a wealth of epidemiological information about the risk factors for childhood obesity and the types of interpersonal, contextual and environmental factors that can influence eating behaviours. All of these are important targets for intervention. In addition, our work, including our systematic review, highlighted the importance of considering the cultural acceptability of interventions for different ethnicities and also the acceptability of interventions for low-income groups. In the current workstream we describe the development of a culturally acceptable childhood obesity prevention programme using a technique called intervention mapping. 159 This has been published as a separate paper. 160

Intervention mapping refers to a rigorous and systematic approach to developing evidence-based interventions. We followed the six key steps as follows: (1) needs assessment of parents, the wider community and practitioners and consideration of the evidence base, policy and practice; (2) identification of outcomes and change objectives following identification of barriers to behaviour change; (3) selection of theory-based methods and practical strategies to address barriers to behaviour change; (4) design of the intervention by developing evidence-based interactive activities and resources; (5) creating an adoption and implementation plan in which parenting practitioners were trained by health-care professionals to deliver the intervention within children’s centres; and (6) creating an evaluation plan.

A multidisciplinary intervention development team was convened that included experts in the areas of parenting, nutrition, breastfeeding and physical activity as well as a group of experienced community health practitioners. The group met every 6–8 weeks over the course of a 12-month period to develop the intervention. The intervention was informed by behavioural change principles161,162 and a typology of ways of ensuring the cultural adaptation of interventions informed the development of the intervention at each stage of the process. 163

The overall desired outcome of the intervention was to prevent childhood obesity. The intervention was targeted at overweight or obese pregnant mothers. Specifically, it aimed to (1) encourage mothers to make healthy food choices antenatally and maintain a healthy diet postnatally; (2) encourage mothers to increase their level of physical activity during pregnancy and meet the recommended guidelines for physical activity (150 minutes of moderate-intensity physical activity per week164) within 12 months of giving birth; (3) encourage breastfeeding (or appropriate bottle-feeding) until at least 6 months of age; (4) encourage infants to develop healthy food preferences and a healthy dietary intake; and (5) facilitate physical activity in infants and limit sedentary time.

Given that parenting skills were highlighted as an important predictor of later obesity (see Early risk factors for childhood obesity), it was agreed that the intervention should be developed in conjunction with an established community parenting programme: the Family Links Nurturing Programme (FLNP). The FLNP is one of the preferred parenting programmes in Bradford; its aims are to develop parents’ self-esteem and self-efficacy and their understanding of their own, and their children’s, emotional and physical needs. Qualitative research has demonstrated that parents value the programme and feel that it has had a positive impact on family relationships, their children’s behaviour, relationship quality and their own mental health. 165,166 This integration with the FLNP was key to ensure the sustainability of the intervention and represented a channel to ensure delivery as part of ’usual care’ that could continue without the involvement of the research team. The parenting aspects of the intervention developed by the FLNP aimed to reduce the risk of child abuse and neglect, improve couple relationships, reduce stress and perinatal depression and increase prospective parents’ understanding of child development. In recognition of this core component of the intervention, the intervention was designed to be delivered by facilitators trained and accredited by the FLNP [see https://familylinks.org.uk/train-with-us (accessed 8 March 2016) for details of the training].

The final intervention consisted of six group antenatal sessions and six group postnatal sessions and was named HAPPY (Healthy and Active Parenting Programme for early Years). It was planned that the antenatal sessions would take place weekly, starting when the mother was at 26–28 weeks’ gestation. Each session lasted approximately 2.5 hours. The postnatal sessions started when the infant was aged 4–6 weeks and continued at key developmental milestones (9 weeks, 12 weeks, 5 months, 7 months and 9 months). A summary of the intervention content for the antenatal sessions and the postnatal sessions can be found in Tables 1 and 2 respectively. Each session was detailed in a facilitator manual with step-by-step instructions on how to deliver the intervention. A 2-day training programme was developed to supplement the existing FLNP training that practitioners had already received. This included information on the background to the intervention mapping approach taken to develop the intervention; evidence-based practical education on the key messages of the intervention (nutrition, infant feeding and physical activity); time to explore the manual and practice delivering activities; and information on the importance of intervention fidelity, including how to record deviations in delivery.

The intervention mapping process, with its focus on multidisciplinary intervention development, resulted in the development of a multifaceted and evidence-based programme, capable of being integrated into existing health services within a multiethnic community in the UK. To our knowledge, this is the first childhood obesity prevention intervention of its kind with a focus on cultural appropriateness that integrates evidence based on physiological and psychosocial data collected from the local community.

The intervention mapping process was complex, time-consuming and not without challenges. These included managing competing interests from the stakeholder group and ensuring that the team understood enough about the technicalities of the process to ensure that appropriate intervention strategies were being highlighted.

Feasibility randomised controlled trial of the Healthy and Active Parenting Programme for Early Years intervention

Having developed the HAPPY intervention, the current workstream aimed to test its feasibility and acceptability in a feasibility RCT (Phase II trial). We also aimed to provide information to inform the development of a full RCT (Phase III trial). The results of this feasibility RCT have been reported in a published article. 167

The specific objectives of the feasibility trial were to (1) establish the number of eligible participants in a maternity unit setting and an achievable recruitment rate; (2) establish the follow-up and attrition rates for the control and intervention groups; (3) assess the acceptability of the randomisation strategy and measurement tools; (4) determine whether or not data required for economic analysis can be collected reliably; (5) determine the primary outcome measure to estimate effect size and intraclass correlation coefficients to enable an accurate sample size calculation for a full trial; (6) assess the acceptability of the HAPPY intervention to parents and facilitators; (7) evaluate the fidelity of programme implementation and delivery by facilitators and (8) establish the capability and capacity of children’s service providers to deliver and incorporate the intervention into their programme of work.

An individually randomised controlled feasibility trial with blinded assessment was conducted. Inclusion criteria were being overweight or obese (having a BMI of ≥ 25 kg/m² at the time of the pregnancy booking visit), being at least 18 years of age, able to attend intervention sessions and able to understand intervention sessions in the English language. Eligible participants were randomised to either an intervention group or a control group (usual care) in a 1 : 1 ratio stratified by maternal BMI (25–29.9 kg/m²/≥ 30 kg/m²), ethnicity (South Asian/other) and parity (first child/at least one other child). Participants completed questionnaires at baseline (T0, prior to randomisation, approximately 24 weeks’ gestation) in their home and again when their baby was 6 months old (T1, approximately 10 months after baseline, telephone interview) and 12 months old (T2, approximately 16 months after baseline, in person). Observations, qualitative interviews and structured questionnaires with facilitators were used to explore acceptability and fidelity. The trial was approved by the Bradford Research Ethics Committee (reference number 11/YH/0458) (trial registration number ISRCTN56735429).

The recruitment rate of those screened with a BMI of ≥ 25 kg/m² was 30% (120/396). A Consolidated Standards of Reporting Trials (CONSORT) flow diagram can be found in Figure 2. Retention at 12 months was 66% for the intervention group and 75% for the control group. Of the 59 allocated to the intervention, 26 (44%) attended at least one antenatal appointment (attending on average 4.8 sessions) and 18 (31%) attended at least one postnatal session (average 4.6 sessions). Participants expressed some burden with regard to the baseline questionnaire assessment, particularly around the self-reported assessment of diet and physical activity. Responses to randomisation were mixed and there was some evidence that women were unsure of the reasons why they had been asked to take part, highlighting some problems with effective communication during the screening period. We found no problems with collecting economic data (service use and quality of life) at either the 6-month or the 12-month follow-up period.

FIGURE 2.

Consolidated Standards of Reporting Trials (CONSORT) flow diagram of study recruitment and retention. a, A small number of women ticked more than one reason, so totals add up to 129; b, recruitment target reached.

We explored a range of appropriate possible outcome measures: age- and sex-adjusted z-score at 12 months; conditional weight gain > 1 centile band; conditional weight gain > 2 centile bands; and weight > 85th centile at 12 months. Analysis indicated that any could be considered in a future Phase III trial. The adjusted effect size using age and standardised weight z-score at 12 months was 0.25 (95% CI –0.16 to 0.66, adjusted for maternal BMI, parity and ethnicity), favouring the intervention. After discussion with a range of clinical experts, with regard to the sample size calculation, we felt that it was important in the definitive trial to take into account the ideal minimum clinically important difference (MCID) and also ensure that the follow-up period would be long enough to give confidence in the sustained impact of the intervention. We selected a MCID of 0.3 BMI SDS at 24 months as the effect size for our Phase III trial.

Participant and facilitator reaction to the intervention content was positive overall. For those in the intervention group there were no associations between attendance at intervention sessions and maternal age, gestational age, parity, booking BMI or ethnicity. Reasons for non-attendance at intervention sessions were explored with seven mothers. Some mothers (3/7) knew from the start of the project (e.g. baseline visit) that they would not be able to attend sessions because of work commitments or other concerns. Others found attendance difficult because of the timing and locations of the sessions.

Fidelity as assessed by observations of sessions and facilitator logs was high. There were some issues with certain sessions with facilitators feeling that there was too much content to cover in the time allotted, but on the whole facilitators rated delivery as straightforward/easy. Facilitators expressed some disappointment at the low numbers of women attending the sessions (ranging between two and six respondents per session).

Each intervention session was delivered by two parenting programme facilitators and required 4.5 hours of facilitator time in total (2.5 hours delivery, 1.5 hours preparation, 30 minutes contacting families). This amounted to typical staff costs of £142 per session, assuming a mix of seniority. All rooms were provided free of charge in local children’s centres. Training time of 3 days per facilitator was required to allow them to deliver the intervention. One-off materials required to run the group (e.g. manuals for facilitators, reference books and DVD) cost £425 and materials for individual participants (e.g. parenting puzzle book, small gifts such as magnets, gift for child) cost £36 per participant. The total cost of staff time to deliver the training was £1163.

The feasibility trial suggests that recruitment and measurement for a definitive trial is feasible and that the HAPPY intervention is acceptable to parents and facilitators. Our experiences of recruitment are in line with those in other similar studies168–171 and our process evaluation has identified valuable areas to consider to improve intervention attendance. For example, participants allocated to the intervention who engaged early (i.e. came to the first session) were likely to continue to attend future sessions. However, there was a high overall attrition rate, with many participants lost early. This was largely because the team was unable to make contact with participants (after multiple attempts to call, visit homes and search GP records). It is clear that multiple methods of contact need to be collected at baseline and then during every subsequent assessment, including contacts for extended family members, friends and neighbours. One option that we plan to explore for a definitive full trial is the possibility of obtaining e-mail addresses and social media identities, which would be validated at recruitment. In addition, qualitative data from participants also indicated that not all of those recruited fully understood the requirements of being involved in the trial. As a consequence, some were not committed to being involved.

Based on our learning and other similar trials of complex interventions, we recommend a range of strategies to maximise intervention attendance and ensure optimal group sizes for the full trial. First, it is important for research midwives to provide more information at screening and recruitment about the nature of the trial and the expectations of participants. It is hoped that this will avoid the problem of recruiting individuals who are not committed or who are not likely to participate in the intervention should they be randomised. Second, post-randomisation home visits by facilitators should be planned to meet participants and set expectations about the intervention and to encourage attendance at the first intervention session.

We found that recruitment through research nurses is feasible and this has enabled us to set realistic recruitment targets for future centres who might be involved in a full trial. Within the current feasibility study we recruited an average of 13 participants per month despite a slowing of recruitment experienced during the month of Ramadan. Given that many larger maternity units recruit to competing trials, we believe that a realistic recruitment target of around nine women per month would be feasible.

This feasibility study has a number of important lessons for the planned definitive trial. We found that recruitment and study attrition rates were in line with those in other similar trials. On the whole, measurement tools and randomisation posed no major problems for study participants, although there were some issues with the assessment of potential secondary outcomes for physical activity. Participants, facilitators and service providers found the intervention to be useful and the fidelity of implementation was high. Although there was a high dropout rate for the initial intervention session, our findings suggest that those who attended the first session were likely to continue attending.

The current findings were considered sufficiently encouraging to develop a definitive Phase III trial. A funding application is currently under way.

One of the biggest challenges of the Phase II trial was setting up intervention groups of 8–10 women who were within 6 weeks’ gestation of each other and who lived in close proximity to one another. As a result, groups often did not run to capacity. This clearly impacted on costs and had an impact on the group dynamics. In response, we have changed the design so that, instead of conducting individual randomisation, clusters of 10 women will be allocated to the intervention or control together so that groups can be delivered to capacity (with individual randomisation, if it is feasible to recruit only 10 women within 6 weeks, there would not be enough to run a group after randomisation is considered). In addition, we plan to deliver the intervention in a central location with good transport links (similar to other antenatal classes) so that we do not have to wait for sufficient numbers of women to be recruited from a given postcode.

Conclusions and recommendations

Acknowledgements

We are grateful to all of the families who took part in this study, the midwives for their help in recruiting them, the paediatricians and health visitors and the Born in Bradford team, which included interviewers, data managers, laboratory staff, clerical workers, research scientists, volunteers and managers.

We are particularly grateful to Pauline Raynor for her wonderful leadership and management in the recruitment of the BiB1000 cohort and to Derek Tuffnell for his clinical support. The development of the nutritional components of the HAPPY intervention owes much to the dedication and support of Jackie Loach and Judith Sargent and her team of Family Links facilitators, who were the driving force behind the successful implementation of the intervention. Ann Barratt helped to ensure that strong public engagement shaped the research from start to finish. Carolyn Clover and Lynn McVey provided indispensable administrative support.

The success of this programme is the result of the hard work and dedication of the following research staff: Dagmar Wailblinger, Sameera Ali, Kate Thompson, Samina Janjua, Sarah Ahmed, Zille Rabab, Jackie Bannister, Asma Hussain, Jo Stott, Rosalie Jozefek, Kerrie Jennings, Chrissie Bradley, Umar Toseeb, Aliyah Rizvi, Sameah Sabir, Emma Snowden, Julia Blackburn, Rihab Potrick, Syeda Ahmad, Natalie Baker and Julia Hackett.

We are grateful to completed and current PhD students who have worked on the BiB1000 study. These include Will Johnson, Jane West, Noortje Uphoff, Tom Norris, Daniel Bingham, Teumzghi Mebrahtu and Katy Shire (completed) and Hannah Roberts and Katie Marvin-Dowle (current).

Steering group members include John Wright, Carolyn Summerbell, Amanda Farrin, Diane Farrar, Emily Petherick, Gerry Richardson, Jackie Loach, Judith Sargent, Maria Bryant, Neil Small, Noel Cameron, Pinki Sahota, Raj Bhopal, Rosie McEachan, Sally E Barber and Shaheen Akhtar.

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Appendix 1 Reports of studies not yet published

(PDF download)

Appendix 2 Further details of data collection instruments

Appendix 3 Full texts of publications that are not open access

Appendix 4 Born in Bradford and the Twins Grow Up

Photographs Ian Beesley, poems Ian McMillan. Copyright permissions for the poems and photographs are held by Born in Bradford and permission to reproduce here has been granted. All photographs are used with the written consent of parents.

(PDF download)

List of abbreviations

BiB

Born in Bradford

BMI

body mass index

CI

confidence interval

CVD

cardiovascular disease

FLNP

Family Links Nurturing Programme

GIS

geographic information systems

HAPPY

Healthy and Active Parenting Programme for early Years

MCID

minimum clinically important difference

MOS

Mealtime Observation Schedule

NICE

National Institute for Health and Care Excellence

NIHR

National Institute for Health Research

OA

output area

RCT

randomised controlled trial

SDS

standard deviation score