Differential effects of diet and physical activity interventions in pregnancy to prevent gestational diabetes mellitus and reduce gestational weight gain by level of maternal adiposity: a protocol for an individual patient data (IPD) meta-analysis of randomised controlled trials

Abstract

Introduction: Women and their infants are at increased risk of complications if gestational diabetes mellitus (GDM) or excessive gestational weight gain (GWG) occurs in pregnancy. Weight management interventions in pregnancy, consisting of diet and physical activity components are targeted based on maternal body mass index (BMI). However, the relative effectiveness of interventions targeted based on alternative measures of adiposity to BMI is unclear. This individual patient data (IPD) meta-analysis aims to explore whether interventions are more effective at preventing GDM and reducing GWG in women according to their level of adiposity.

Methods: The International Weight Management in Pregnancy Collaborative Network has a living database of IPD from randomised trials of diet and/or physical activity interventions in pregnancy. This IPD meta-analysis will use IPD from trials identified from systematic literature searches up until March 2021, where maternal adiposity measures (eg, waist circumference) were collected prior to 20 weeks' gestation. A two-stage random effects IPD meta-analysis approach will be taken for each outcome (GDM and GWG) to understand the effect of early pregnancy adiposity measures on the effect of weight management interventions for GDM prevention and GWG reduction. Summary intervention effects with 95% CIs) will be derived along with treatment covariate interactions. Between-study heterogeneity will be summarised by I² and tau² statistics. Potential sources of bias will be evaluated, and the nature of any missing data will be explored and appropriate imputation methods adopted.

Ethics and dissemination: Ethics approval is not required. The study is registered on the International Prospective Register of Systematic Reviews (CRD42021282036). Results will be submitted to peer-reviewed journals.

Prospero registration number: CRD42021282036.

Keywords: Diabetes in pregnancy; OBSTETRICS; STATISTICS & RESEARCH METHODS.