Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
NIHR Oxford Biomedical Research Centre, Oxford, UK.
BMJ Open. 2022 Sep 1;12(9):e060951. doi: 10.1136/bmjopen-2022-060951.
Previous trials of dietary interventions to prevent gestational diabetes mellitus (GDM) have yielded only limited success. Low-carbohydrate diets have shown promise for the treatment of type 2 diabetes, but there is no evidence to support their use in pregnancy. The aim of this study is to explore the feasibility of a moderately reduced-carbohydrate dietary intervention delivered from mid-pregnancy alongside routine antenatal care.
This is a feasibility randomised controlled trial (RCT) with embedded qualitative study. Sixty women who are pregnant <20 weeks' gestation, with body mass index ≥30 kg/m at their antenatal booking appointment, will be randomised 2:1 intervention or control (usual care) and followed up until delivery. The intervention is a moderately reduced-carbohydrate diet (~130-150 g total carbohydrate/day), designed to be delivered alongside routine antenatal appointments. Primary outcomes are measures of adoption of the diet and retention of participants. Secondary outcomes include incidence of GDM, change in markers of glycaemic control, gestational weight gain, total carbohydrate and energy intake. Process outcomes will examine resources and management issues. Exploratory outcomes include further dietary changes, quality of life, maternal and neonatal outcomes, and qualitative measures.
This trial was reviewed and approved by the South-Central Oxford B Research Ethics Committee NHS National Research Ethics Committee and the Health Research Authority (Reference: 20/SC/0442). The study results will inform whether to progress to a full-scale RCT to test the clinical effectiveness of the RECORD programme to prevent GDM in women at high risk. The findings will be published in peer-reviewed journals and presented at conferences.
ISRCTN16235884.
先前针对妊娠糖尿病（GDM）的饮食干预试验仅取得了有限的成功。低碳水化合物饮食已被证明可有效治疗 2 型糖尿病，但尚无证据支持其在妊娠期间使用。本研究旨在探索从中孕期开始并结合常规产前护理的适度低碳水化合物饮食干预措施的可行性。
这是一项可行性随机对照试验（RCT），并嵌入了定性研究。将 60 名妊娠<20 周、BMI≥30kg/m2 的孕妇在产前预约时随机分为 2:1 的干预组或对照组（常规护理），并随访至分娩。干预措施是一种适度减少碳水化合物的饮食（约 130-150g 总碳水化合物/天），旨在与常规产前预约同时进行。主要结局是评估饮食的采用和参与者的保留情况。次要结局包括 GDM 的发生率、血糖控制标志物的变化、妊娠体重增加、总碳水化合物和能量摄入。过程结局将检查资源和管理问题。探索性结局包括进一步的饮食变化、生活质量、母婴结局和定性措施。
该试验已由南中英格兰牛津 B 研究伦理委员会 NHS 国家伦理委员会和健康研究管理局审查和批准（参考号：20/SC/0442）。研究结果将决定是否进行全面的 RCT 以测试 RECORD 计划预防高危孕妇 GDM 的临床效果。研究结果将发表在同行评议的期刊上，并在会议上展示。
ISRCTN83113604。
