Loading...
The HAPPY (Healthy and Active Parenting Programme for Early Years) feasability randomised control trial: acceptability and feasability of an intervention to reduce infant Obesity
Santorelli, G. Bryant, M. Sahota, P. Farrar, D. Small, Neil A. Akhtar, Shaheen Sargent, J. Barber, Sally E. Taylor, N.
Santorelli, G.
Bryant, M.
Sahota, P.
Farrar, D.
Small, Neil A.
Akhtar, Shaheen
Sargent, J.
Barber, Sally E.
Taylor, N.
Publication Date
2016-03-01
End of Embargo
Supervisor
Rights
© 2016 The Authors. This is an Open Access article distributed under the
Creative Commons CC-BY license (https://creativecommons.org/licenses/by/4.0/)
Peer-Reviewed
Yes
Open Access status
openAccess
Accepted for publication
2016-02-12
Institution
Department
Awarded
Embargo end date
Collections
Additional title
Abstract
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.
Version
Published version
Citation
McEachan R, Santorelli G, Bryant M et al. (2016) The HAPPY (Healthy and Active
Parenting Programmme for early Years) feasibility randomised control trial: acceptability and
feasibility of an intervention to reduce infant obesity. BMC Public Health. 16: 211.
Link to publisher’s version
Link to published version
Link to Version of Record
Type
Article