Time restricted eating and exercise training before and during pregnancy for people with increased risk of gestational diabetes: single centre randomised controlled trial (BEFORE THE BEGINNING).

Methods

Single centre randomised controlled trial(BEFORE THE BEGINNING).

单中心随机对照试验（在开始之前）。

University hospital in Trondheim, Norway.

挪威特隆赫姆大学医院。

167 participants with at least one risk factor for gestational diabetes mellitus who contemplated pregnancy.

167名参与者至少有一种妊娠糖尿病的风险因素，并考虑怀孕。

intervention

The participants were randomly allocated (1:1) to a lifestyle intervention or a standard care control group.

参与者被随机分配（1:1）到生活方式干预组或标准护理对照组。

The intervention consisted of exercise training and time restricted eating, started before pregnancy and continued throughout pregnancy.

干预措施包括运动训练和限时进食，开始于怀孕前并持续整个怀孕期间。

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.

运动量是通过将心率转换为得分的体力活动指标来设定的（个人活动智能，PAI），目标是每周至少100个PAI点。

Time restricted eating involved consuming all energy within ≤10 hours/day for at least five days a week.

时间限制饮食涉及在每天≤10小时内摄入所有能量，每周至少五天。

Methods

Two hour plasma glucose level in an oral glucose tolerance test at gestational week 28.

在妊娠第28周进行的口服葡萄糖耐量试验中，2小时血浆葡萄糖水平。

The primary analysis used an intention-to-treatprinciple.

主要分析采用了意向治疗原则。

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).

2020年10月2日至2023年5月12日期间，共有167名参与者被纳入研究：干预组84人，对照组83人，其中111人怀孕（干预组56人，对照组55人）。

One participant in the intervention group was excluded from the analysis because of prepregnancy diabetes.

由于妊娠前糖尿病，干预组有一名参与者被排除在分析之外。

Pregnancy data from one participant in the control group were excluded from the analysis because of twin pregnancy.

对照组中一名参与者的怀孕数据因双胞胎怀孕而被排除在分析之外。

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).

在妊娠第28周进行的口服葡萄糖耐量测试中，干预措施对两小时血浆葡萄糖水平没有显著影响（平均差异0.48毫摩尔/升，95%置信区间-0.05至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.

在孕前期间，干预组中有31/83名参与者（37%）遵守了预先设定的标准，而在干预组中怀孕的24/55名参与者（44%）满足了这些标准。

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.

在孕前期间，平均饮食窗口为每天9.9小时（标准差1.2），平均每周的PAI分数为111（标准差54），但这两项干预措施的遵守度在怀孕期间有所下降。

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.

在孕晚期，限制饮食时间与锻炼训练相结合，并在怀孕前开始并持续整个孕期，对血糖控制没有显著影响。

trial_registration

ClinicalTrials.gov NCT04585581.

ClinicalTrials.gov NCT04585581。