The HAPPY (Healthy and Active Parenting Programmme for early Years) feasibility randomised control trial: acceptability and feasibility of an intervention to reduce infant obesity.

BACKGROUND: The prevalence of infant obesity is increasing, but there is a lack of evidence-based approaches to prevent obesity at this age. This study tested the acceptability and feasibility of evaluating a theory-based intervention aimed at reducing risk of obesity in infants of overweight/obese women during and after pregnancy: the Healthy and Active Parenting Programme for Early Years (HAPPY). METHODS: A feasibility randomised controlled trial was conducted in Bradford, England. One hundred twenty overweight/obese pregnant women (Body Mass Index [BMI] ≥25 kg/m(2)) were recruited between 10-26 weeks gestation. Consenting women were randomly allocated to HAPPY (6 antenatal, 6 postnatal sessions: N = 59) or usual care (N = 61). Appropriate outcome measures for a full trial were explored, including: infant's length and weight, woman's BMI, physical activity and dietary intake of the women and infants. Health economic data were collected. Measurement occurred before randomisation and when the infant was aged 6 months and 12 months. Feasibility outcomes were: recruitment/attrition rates, and acceptability of: randomisation, measurement, and intervention. Intra-class correlations for infant weight were calculated. Fidelity was assessed through observations and facilitator feedback. Focus groups and semi-structured interviews explored acceptability of methods, implementation, and intervention content. RESULTS: Recruitment targets were met (~20 women/month) with a recruitment rate of 30 % of eligible women (120/396). There was 30 % attrition at 12 months; 66 % of recruited women failed to attend intervention sessions, but those who attended the first session were likely to continue to attend (mean 9.4/12 sessions, range 1-12). Reaction to intervention content was positive, and fidelity was high. Group clustering was minimal; an adjusted effect size of -0.25 standard deviation scores for infant weight at 12 months (95 % CI: -0.16-0.65) favouring the intervention was observed using intention to treat analyses. No adverse events were reported. CONCLUSIONS: The HAPPY intervention appeared feasible and acceptable to participants who attended and those delivering it, however attendance was low; adaptations to increase initial attendance are recommended. Whilst the study was not powered to detect a definitive effect, our results suggest a potential to reduce risk of infant obesity. The evidence reported provides valuable lessons to inform progression to a definitive trial. TRIAL REGISTRATION: Current Controlled Trials ISRCTN56735429.

Using intervention mapping to develop a culturally appropriate intervention to prevent childhood obesity: the HAPPY (Healthy and Active Parenting Programme for Early Years) study.

INTRODUCTION: Interventions that make extensive use of theory tend to have larger effects on behaviour. The Intervention Mapping (IM) framework incorporates theory into intervention design, implementation and evaluation, and was applied to the development of a community-based childhood obesity prevention intervention for a multi-ethnic population. METHODS: IM was applied as follows: 1) Needs assessment of the community and culture; consideration of evidence-base, policy and practice; 2) Identification of desired outcomes and change objectives following identification of barriers to behaviour change mapped alongside psychological determinants (e.g. knowledge, self-efficacy, intention); 3) Selection of theory-based methods and practical applications to address barriers to behaviour change (e.g., strategies for responsive feeding); 4) Design of the intervention by developing evidence-based interactive activities and resources (e.g., visual aids to show babies stomach size). The activities were integrated into an existing parenting programme; 5) Adoption and implementation: parenting practitioners were trained by healthcare professionals to deliver the programme within Children Centres. RESULTS: HAPPY (Healthy and Active Parenting Programme for Early Years) is aimed at overweight and obese pregnant women (BMI > 25); consists of 12 × 2.5 hr. sessions (6 ante-natal from 24 weeks; 6 postnatal up to 9 months); it addresses mother's diet and physical activity, breast or bottle feeding, infant diet and parental feeding practices, and infant physical activity. CONCLUSION: We have demonstrated that IM is a feasible and helpful method for providing an evidence based and theoretical structure to a complex health behaviour change intervention. The next stage will be to assess the impact of the intervention on behaviour change and clinical factors associated with childhood obesity. The HAPPY programme is currently being tested as part of a randomised controlled feasibility trial.