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

Abstract

BackgroundThe 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).MethodsA feasibility randomised controlled trial was conducted in Bradford, England. One hundred twenty overweight/obese pregnant women (Body Mass Index [BMI] ≥25 kg/m2) 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.ResultsRecruitment 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.ConclusionsThe 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 RegistrationCurrent Controlled Trials ISRCTN56735429Electronic supplementary materialThe online version of this article (doi:10.1186/s12889-016-2861-z) contains supplementary material, which is available to authorized users.

Do lifestyle interventions during pregnancy have the potential to reduce long‐term postpartum weight retention? A systematic review and meta‐analysis

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Comparing Written Versus Pictorial Asthma Action Plans to Improve Asthma Management and Health Outcomes Among Children and Adolescents: Protocol of a Pilot and Feasibility Randomized Controlled Trial (Preprint)

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

“…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.…”