Yes / 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/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.
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. / National Institute for Health Research
| Identifer | oai:union.ndltd.org:BRADFORD/oai:bradscholars.brad.ac.uk:10454/10068 |
| Date | 12 February 2016 |
| Creators | McEachan, Rosemary, Santorelli, G., Bryant, M., Sahota, P., Farrar, D., Small, Neil A., Akhtar, Shaheen, Sargent, J., Barber, Sally E., Taylor, N., Richardson, G., Farrin, A.J., Bhopal, R.S., Bingham, Daniel, Ahern, S.M., Wright, J. |
| Source Sets | Bradford Scholars |
| Language | English |
| Detected Language | English |
| Type | Article, Published version |
| Rights | © 2016 McEachan et al. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
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