Sujan Ma Jafar, Skarstad Hanna Ms, Rosvold Guro, Fougner Stine L, Follestad Turid, Salvesen Kjell Å, Moholdt Trine
Department of Circulation and Medical Imaging, Norwegian University of Science and Technology, Trondheim, Norway.
Department of Women's Health, St Olav's Hospital, Trondheim University Hospital, Trondheim, Norway.
BMJ. 2025 Sep 9;390:e083398. doi: 10.1136/bmj-2024-083398.
To determine the effect of a prepregnancy lifestyle intervention on glucose tolerance in people at higher risk of gestational diabetes mellitus.
Single centre randomised controlled trial (BEFORE THE BEGINNING).
University hospital in Trondheim, Norway.
167 participants with at least one risk factor for gestational diabetes mellitus who contemplated pregnancy.
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.
Two hour plasma glucose level in an oral glucose tolerance test at gestational week 28. The primary analysis used an intention-to-treat principle.
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.
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.
ClinicalTrials.gov NCT04585581.
确定孕前生活方式干预对妊娠期糖尿病风险较高人群糖耐量的影响。
单中心随机对照试验（孕前开始）。
挪威特隆赫姆的大学医院。
167名有至少一项妊娠期糖尿病风险因素且计划怀孕的参与者。
参与者被随机分配（1:1）至生活方式干预组或标准护理对照组。干预包括运动训练和限时进食，在怀孕前开始并持续整个孕期。运动强度根据将心率转化为分数的身体活动指标（个人活动智能，PAI）设定，目标是每周PAI分数≥100分。限时进食要求每周至少五天在≤10小时内摄入所有能量。
孕28周时口服葡萄糖耐量试验中的两小时血浆葡萄糖水平。主要分析采用意向性分析原则。
2020年10月2日至2023年5月12日共招募了167名参与者：干预组84名，对照组83名，其中111人怀孕（干预组56人，对照组55人）。干预组有一名参与者因孕前糖尿病被排除在分析之外。对照组有一名参与者因双胎妊娠，其妊娠数据被排除在分析之外。干预对孕28周时口服葡萄糖耐量试验中的两小时血浆葡萄糖水平无显著影响（平均差异0.48 mmol/L，95%置信区间-0.05至1.01，P = 0.08）。在孕前阶段，干预组83名参与者中有31名（37%）符合预定标准，而干预组中怀孕的55名参与者中有24名（44%）符合这些标准。在孕前阶段，平均进食窗口为每天9.9小时（标准差1.2），每周PAI分数平均为111分（标准差54），但在孕期对两种干预成分的依从性均下降。
孕前开始并持续整个孕期的限时进食与运动训练相结合对孕晚期血糖控制无显著影响。
ClinicalTrials.gov NCT04585581
