Healthy eating and lifestyle in pregnancy (HELP): A cluster randomised trial to evaluate the effectiveness of a weight management intervention for pregnant women with obesity on weight at 12 months postpartum

Simpson, S. et al. (2021) Healthy eating and lifestyle in pregnancy (HELP): A cluster randomised trial to evaluate the effectiveness of a weight management intervention for pregnant women with obesity on weight at 12 months postpartum. International Journal of Obesity, 45(8), pp. 1728-1739. (doi: 10.1038/s41366-021-00835-0) (PMID:34021264)

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Abstract

Objective: To assess whether a weight management intervention for pregnant women with obesity was effective in reducing body mass index (BMI) 12 months after giving birth. Methods: Pragmatic, cluster randomised controlled trial (RCT) with embedded cost-effectiveness analysis. 598 women with a BMI of ≥30 kg/m2 (between 12 and 20 weeks gestation) were recruited from 20 secondary care maternity units in England and Wales. BMI at 12 months postpartum was the primary outcome. A range of clinical and behavioural secondary outcomes were examined. Interventions: Women attending maternity units randomised to intervention were invited to a weekly weight management group, which combined expertise from a commercial weight loss programme with clinical advice from midwives. Both intervention and control participants received usual care and leaflets on diet and physical activity in pregnancy. Results Mean (SD) BMI at 12 months postpartum was 36.0 kg/m2 (5.2) in the control group, and 37.5 kg/m2 (6.7) in the intervention group. After adjustment for baseline BMI, the intervention effect was −0.02 (95% CI −0.04 to 0.01). The intervention group had an improved healthy eating score (3.08, 95% CI 0.16 to 6.00, p < 0.04), improved fibre score (3.22, 1.07 to 5.37, p < 0.01) and lower levels of risky drinking at 12 months postpartum compared to the control group (OR 0.45, 0.27 to 0.74, p < 0.002). The net incremental monetary benefit was not statistically significantly different between arms, although the probability of the intervention being cost-effective was above 60%, at policy-relevant thresholds. Conclusions: There was no significant difference between groups on the primary outcome of BMI at 12 months. Analyses of secondary outcomes indicated improved healthy eating and lower levels of risky drinking.

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Robles-Zurita, Dr Jose Antonio and McIntosh, Professor Emma and Simpson, Professor Sharon
Authors: Simpson, S., Coulman, E., Gallagher, D., Jewell, K., Cohen, D., Newcombe, R. G., Huang, C., Robles, J. A., Busse, M., Owen-Jones, E., Duncan, D., Williams, N., Stanton, H., Avery, A., McIntosh, E., and Playle, R.
College/School:College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > Health Economics and Health Technology Assessment
College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > MRC/CSO SPHSU
Journal Name:International Journal of Obesity
Publisher:Nature Research
ISSN:0307-0565
ISSN (Online):1476-5497
Published Online:21 May 2021
Copyright Holders:Copyright © 2021 Crown
First Published:First published in International Journal of Obesity 45(8): 1728-1739
Publisher Policy:Reproduced under a Creative Commons licence

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Project CodeAward NoProject NamePrincipal InvestigatorFunder's NameFunder RefLead Dept
168560MRC SPHSU/GU Transfer FellowshipsLaurence MooreMedical Research Council (MRC)MC_PC_13027HW - MRC/CSO Social and Public Health Sciences Unit
727661SPHSU Core Renewal: Complexity in Health Improvement Research ProgrammeLaurence MooreMedical Research Council (MRC)MC_UU_12017/14IHW - MRC/CSO SPHU
Office of the Chief Scientific Adviser (CSO)SPHSU14
Complexity in healthMedical Research Council (MRC)MC_UU_00022/1HW - MRC/CSO Social and Public Health Sciences Unit
Office of the Chief Scientific Adviser (CSO)SPHSU16