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, Sharon A.; Coulman, Elinor; Gallagher, Dunla; Jewell, Karen; Cohen, David; Newcombe, Robert G.; Huang, Chao; Robles, Jose Antonio; Busse, Monica; Owen-Jones, Eleri; Duncan, Donna; Williams, Nefyn; Stanton, Helen; Avery, Amanda; McIntosh, Emma; Playle, Rebecca

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/m (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/m (5.2) in the control group, and 37.5 kg/m (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. Trial registration: Current Controlled Trials ISRCTN25260464. 2 2 2

Citation

Simpson, S. A., 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., & Playle, R. (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), 1728-1739. https://doi.org/10.1038/s41366-021-00835-0

• Journal Article Type: Article
• Acceptance Date: Apr 23, 2021
• Online Publication Date: May 21, 2021
• Publication Date: 2021-08
• Deposit Date: Sep 13, 2021
• Publicly Available Date: Sep 13, 2021
• Journal: International Journal of Obesity
• Print ISSN: 0307-0565
• Electronic ISSN: 1476-5497
• Publisher: Nature Publishing Group
• Peer Reviewed: Peer Reviewed
• Volume: 45
• Issue: 8
• Pages: 1728-1739
• DOI: https://doi.org/10.1038/s41366-021-00835-0
• Keywords: Nutrition and Dietetics; Endocrinology, Diabetes and Metabolism; Medicine (miscellaneous)
• Public URL: https://nottingham-repository.worktribe.com/output/5625968
• Publisher URL: https://www.nature.com/articles/s41366-021-00835-0
• Additional Information: Received: 11 June 2020; Revised: 23 March 2021; Accepted: 23 April 2021; First Online: 21 May 2021; Change Date: 18 October 2021; Change Type: Correction; Change Details: A Correction to this paper has been published:; Change Details: https://doi.org/10.1038/s41366-021-00976-2; : ; : Amanda Avery (AA) has a salaried position at Slimming World. The intervention included components developed by Slimming World and Slimming World provided some of the intervention costs for the study. However, neither AA nor Slimming World had access to the study data or were involved in the data collection or analyses of the study. Slimming World provided an unrestricted educational grant to fund Dunla Gallagher’s doctoral research. The funded research was a separate follow-up study to the current project. No other relationships or activities that could appear to have influenced the submitted work.; : The study was approved by the NHS Wales Research Ethics Committee 3 (Reference number 09/MRE09/58).