Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Oxford, Oxfordshire, UK.
MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.
BMJ Open. 2021 Feb 17;11(2):e042069. doi: 10.1136/bmjopen-2020-042069.
Lifestyle modification is the mainstay of gestational diabetes mellitus (GDM) prevention. However, clinical trials evaluating the safety and efficacy of diet or physical activity (PA) in low-income and middle-income settings such as Africa and India are lacking. This trial aims to evaluate the efficacy of yoghurt consumption and increased PA (daily walking) in reducing GDM incidence in high-risk pregnant women.
The study is a 2×2 factorial, open-labelled, multicentre randomised controlled trial to be conducted in Vellore, South India and The Gambia, West Africa. 'High-risk' pregnant women (n=1856) aged ≥18 years and ≤16 weeks of gestational age, with at least one risk factor for developing GDM, will be randomised to either (1) yoghurt (2) PA (3) yoghurt +PA or (4) standard antenatal care. Participants will be followed until 32 weeks of gestation with total active intervention lasting for a minimum of 16 weeks. The primary endpoint is GDM incidence at 26-28 weeks diagnosed using International Association of the Diabetes and Pregnancy Study Groups criteria or elevated fasting glucose (≥5.1 mmol/L) at 32 weeks. Secondary endpoints include absolute values of fasting plasma glucose concentration at 32 weeks gestation, maternal blood pressure, gestational weight gain, intrapartum and neonatal outcomes. Analysis will be both by intention to treat and per-protocol. Continuous outcome measurements will be analysed using multiple linear regression and binary variables by logistic regression.
The study is approved by Oxford Tropical Research Ethics Committee (44-18), ethics committees of the Christian Medical College, Vellore (IRB 11367) and MRCG Scientific Coordinating Committee (SCC 1645) and The Gambia Government/MRCG joint ethics committee (L2020.E15). Findings of the study will be published in peer-reviewed scientific journals and presented in conferences.
ISRCTN18467720.
生活方式的改变是预防妊娠期糖尿病（GDM）的主要方法。然而，在非洲和印度等中低收入国家和地区，缺乏评估饮食或体力活动（PA）安全性和有效性的临床试验。本试验旨在评估酸奶摄入和增加 PA（日常散步）对降低高危孕妇 GDM 发病率的效果。
这是一项在印度南部的维洛尔和西非冈比亚进行的 2×2 析因、开放标签、多中心随机对照试验。年龄在 18 岁及以上且不超过 16 周妊娠龄、至少有一个发生 GDM 风险因素的“高危”孕妇（n=1856）将被随机分配到以下 4 个组之一：（1）酸奶；（2）PA；（3）酸奶+PA；（4）标准产前护理。参与者将被随访至 32 周妊娠，总积极干预时间至少为 16 周。主要终点是使用国际妊娠糖尿病协会研究组标准或 32 周时空腹血糖升高（≥5.1mmol/L）诊断的 26-28 周 GDM 发病率。次要终点包括 32 周妊娠时空腹血浆葡萄糖浓度的绝对值、产妇血压、妊娠体重增加、分娩时和新生儿结局。分析将按照意向治疗和方案进行。连续变量的测量结果将使用多元线性回归进行分析，二分类变量将使用逻辑回归进行分析。
该研究已获得牛津热带研究伦理委员会（44-18）、维洛尔基督教医学院伦理委员会（IRB 11367）和 MRCG 科学协调委员会（SCC 1645）以及冈比亚政府/MRCG 联合伦理委员会（L2020.E15）的批准。研究结果将发表在同行评议的科学期刊上，并在会议上展示。
ISRCTN85553005。
