RT Journal Article T1 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 A1 Simpson, Sharon A. A1 Coulman, Elinor A1 Gallagher, Dunla A1 Jewell, Karen A1 Cohen, David A1 Newcombe, Robert G. A1 Huang, Chao A1 Robles-Zurita, José Antonio A1 Busse, Monica A1 Owen-Jones, Eleri A1 Duncan, Donna A1 Williams, Nefyn A1 Stanton, Helen A1 Avery, Amanda A1 McIntosh, Emma A1 Playle, Rebecca K1 Obesidad - Tratamiento K1 Embarazo - Aspectos nutricionales AB Objective To assess whether a weight management intervention for pregnant women with obesity was effective in reducingbody mass index (BMI) 12 months after giving birth.Methods Pragmatic, cluster randomised controlled trial (RCT) with embedded cost-effectiveness analysis. 598 women witha BMI of ≥30 kg/m2 (between 12 and 20 weeks gestation) were recruited from 20 secondary care maternity units in Englandand Wales. BMI at 12 months postpartum was the primary outcome. A range of clinical and behavioural secondaryoutcomes were examined.Interventions Women attending maternity units randomised to intervention were invited to a weekly weight managementgroup, which combined expertise from a commercial weight loss programme with clinical advice from midwives. Bothintervention 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 theintervention group. After adjustment for baseline BMI, the intervention effect was −0.02 (95% CI −0.04 to 0.01). Theintervention 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 ofsecondary outcomes indicated improved healthy eating and lower levels of risky drinking. PB Springer Nature YR 2021 FD 2021 LK https://hdl.handle.net/10630/37217 UL https://hdl.handle.net/10630/37217 LA eng NO Simpson, S.A., Coulman, E., Gallagher, D. et al. 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. Int J Obes 45, 1728–1739 (2021). https://doi.org/10.1038/s41366-021-00835-0 NO The study was fundedby the National Prevention Research Initiative (NPRI). SlimmingWorld provided some of the intervention delivery costs whichincluded staff time at Slimming World Head Office and materials forparticipants. SS was supported by the Medical Research Council andthe Chief Scientist Office of the Scottish Government Healthand Social Care Directorates (MC-PC-13027, MC_UU_12017_14and SPHSU14). DS RIUMA. Repositorio Institucional de la Universidad de Málaga RD 19 ene 2026