Postpartum Weight Management Protocol

The primary analysis was by intention to treat (ITT), comparing BMI (kg/m²) between study groups at 12 months postpartum. For all primary and secondary outcomes, multilevel linear models fitted cluster (maternity unit) and individual effects. BMI data were log-transformed for all regression analyses and baseline BMI as well as variables used to balance the randomisation included as covariates. The intervention effect for BMI was therefore interpreted as the percentage difference between groups. Two-level logistic models were used for categorical outcomes. The impact of individual demographic factors as well as theoretical mediators on the intervention effect was investigated (self-efficacy, social support, intrinsic motivation and self-regulation) [20 (link)]. Pre-specified subgroups were examined formally using interaction terms for parity, social class, ethnicity and smoking status. A complier average causal effect (CACE) analysis investigated the effect of intervention group attendance on the primary outcome. The influence of missing data was assessed using multiple imputation under a missing at random assumption. Sensitivity analyses were examined for departures towards missing not at random. All primary and secondary analyses were performed in IBM SPSS Statistics 20 and STATA v13, imputation was performed in STATA v13.

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Simpson S.A., Coulman E., Gallagher D., Jewell K., Cohen D., Newcombe R.G., Huang C., Robles-Zurita 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 (2005), 45(8), 1728-1739.

Publication 2021

STATA v13

Ethnicity Motivation Sensitivity

Corresponding Organization : MRC/CSO Social and Public Health Sciences Unit

Other organizations : Cardiff University, Queen's University Belfast, Welsh Government, University of South Wales, Hull York Medical School, University of Hull, Swansea Bay University Health Board, University of Liverpool, University of Nottingham

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Variable analysis

independent variables

Intervention group

dependent variables

BMI (kg/m^2) at 12 months postpartum
Categorical outcomes

control variables

Baseline BMI
Variables used to balance the randomisation

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