A randomised controlled trial of preconception lifestyle intervention on maternal and offspring health in people with increased risk of gestational diabetes: study protocol for the BEFORE THE BEGINNING trial

Abstract

AbstractIntroductionGestational diabetes mellitus (GDM) is associated with increased risk for type 2 diabetes in the mother and cardiometabolic diseases in the child. The preconception period is an optimal window to adapt the lifestyle for improved outcomes for both mother and child. Our aim is to determine the effect of a lifestyle intervention, initiated before and continued throughout pregnancy, on maternal glucose tolerance and other maternal and infant cardiometabolic outcomes.Methods and analysisThis ongoing randomised controlled trial has included 167 females aged 18-39 years old at increased risk for GDM who are contemplating pregnancy. The participants were randomly allocated 1:1 to an intervention or control group. The intervention consists of exercise (volume is set by a heart rate-based app and corresponds to ≥ 1 hour of weekly exercise at ≥ 80% of individual heart rate maximum), and time-restricted eating (≤ 10 hours/day window of energy intake). The primary outcome measure is glucose tolerance in gestational week 28. Maternal and offspring outcomes are measured before and during pregnancy, at delivery, and at 6-8 weeks postpartum. Primary and secondary continuous outcome measures will be compared between groups based on the “intention to treat” principle using linear mixed models.Ethics and disseminationThe Regional Committees for Medical and Health Research Ethics in Norway has approved the study (REK 143756). The anonymised results will be submitted for publication and posted in a publicly accessible database of clinical study results.Strengths and limitations of this studyThe intervention starts before and continues throughout pregnancy to make it easier for the participants to adopt an active lifestyle before pregnancy.This study includes individuals at high risk of GDM from multiple ethnic backgrounds, which improves the generalisability of the findings.The effects of the intervention on the cardiac function and body composition of the offspring will be comprehensively evaluated.Due to the difficulty of blinding investigators and participants to behavioural interventions, investigators will not be blinded for outcome assessments.Due to the long duration of the intervention, adherence to lifestyle modifications may be difficult for some participants despite regular monitoring and motivational support.