Abstract
OBJECTIVE: To determine the effect of a prepregnancy lifestyle intervention on glucose tolerance in people at higher risk of gestational diabetes mellitus. DESIGN: Single centre randomised controlled trial (BEFORE THE BEGINNING). SETTING: University hospital in Trondheim, Norway. PARTICIPANTS: 167 participants with at least one risk factor for gestational diabetes mellitus who contemplated pregnancy. INTERVENTION: The participants were randomly allocated (1:1) to a lifestyle intervention or a standard care control group. The intervention consisted of exercise training and time restricted eating, started before pregnancy and continued throughout pregnancy. Exercise volume was set using a physical activity metric that translates heart rate into a score (personal activity intelligence, PAI), with the goal of ≥100 weekly PAI points. Time restricted eating involved consuming all energy within ≤10 hours/day for at least five days a week. MAIN OUTCOME MEASURES: Two hour plasma glucose level in an oral glucose tolerance test at gestational week 28. The primary analysis used an intention-to-treat principle. RESULTS: 167 participants were enrolled from 2 October 2020 to 12 May 2023: 84 in the intervention group and 83 in the control group, out of whom 111 became pregnant (56 in intervention group and 55 in control group). One participant in the intervention group was excluded from the analysis because of prepregnancy diabetes. Pregnancy data from one participant in the control group were excluded from the analysis because of twin pregnancy. The intervention had no significant effect on two hour plasma glucose level in an oral glucose tolerance test at gestational week 28 (mean difference 0.48 mmol/L, 95% confidence interval -0.05 to 1.01, P=0.08). In the prepregnancy period, 31/83 participants (37%) in the intervention group adhered to prespecified criteria, whereas 24/55 participants (44%) in the intervention group who became pregnant fulfilled these criteria. During the prepregnancy period, the average eating window was 9.9 hours/day (standard deviation 1.2) and the average number of weekly PAI points was 111 (standard deviation 54), but the adherence to both intervention components decreased during pregnancy. CONCLUSIONS: A combination of time restricted eating and exercise training started before and continued throughout pregnancy had no significant effect on glycaemic control in late pregnancy. TRIAL REGISTRATION: ClinicalTrials.gov NCT04585581.