个体化营养干预与常规护理预防妊娠期糖尿病的比较：一项随机对照试验。
Individualized nutritional intervention compared with routine care for gestational diabetes prevention: a randomized controlled trial.
作者信息
Wang Lulu, Wang Xipeng, Zhang Rong, Sun Wenguang, Zhang Chenjie, Zhang Chen, Qin Guoyou, Peng Jiahuan, Li Hong, Fan Jianxia, Qu Lei, Ma Liying, Chen Lei, Wu Jiaying, Hao Yanhui, Ruan Huijuan, Zheng Tao, Wu Dongling, Li Shaojing, Liu Yanyan, Wang Man, Lu Huan, Dennis Cindy-Lee, Mol Ben W, Huang Hefeng, Wu Yanting
机构信息
Obstetrics and Gynecology Hospital, Institute of Reproduction and Development, Fudan University, Shanghai, China; Research Units of Embryo Original Diseases, Chinese Academy of Medical Sciences (No. 2019RU056), Shanghai, China.
Department of Obstetrics and Gynecology, Xinhua Hospital, Shanghai Jiao Tong University, Shanghai, China.
出版信息
Am J Clin Nutr. 2025 May;121(5):1199-1209. doi: 10.1016/j.ajcnut.2025.03.006. Epub 2025 Mar 11.
BACKGROUND
Gestational diabetes mellitus (GDM) affects millions of females and their children. Effective dietary strategies for early prevention are controversial.
OBJECTIVES
This study aims to investigate whether an individualized nutritional intervention reduced GDM incidence in high-risk females.
METHODS
A randomized trial was conducted at 3 tertiary hospitals in Shanghai, China. We randomly assigned (1:1) pregnant females in the first trimester who were identified to be at high risk of GDM by a prediction model to either an individualized nutritional intervention or usual care. The intervention consisted of 3 dietary consultations by dietitians based on Chinese dietary guidelines before the oral glucose tolerance test (OGTT) at 24-28 wk of gestation. The control group received usual care. All participants provided 3-d food records at each follow-up. The primary outcome was GDM incidence using the International Association of Diabetes and Pregnancy Study Group criteria. Key secondary outcomes were dietary alterations, gestational weight gain (GWG), maternal metabolic profile, perinatal and pregnancy outcomes. Intention-to-treat analyses were conducted.
RESULTS
A total of 519 females were enrolled, of whom 261 were assigned to the intervention and 258 to usual care. GDM was diagnosed in 85/245 (34.7%) females in the intervention group compared with 89/244 (36.5%) in the control group [adjusted relative risk 0.91 (95% confidence interval: 0.73, 1.15), P = 0.44]. More females in the intervention group had an appropriate GWG than the control group [1.38 (1.06, 1.79)] and lower levels of fasting and 2-h insulin during the OGTT (P < 0.001). We observed a reduction in the rate of small for gestational age in the intervention group compared with the control group [0.11 (0.01, 0.80)] and neonatal hypoglycemia [0.14 (0.04, 0.57)].
CONCLUSIONS
Among females at risk of GDM, an individualized nutritional intervention based on Chinese dietary guidelines provided before the OGTT did not prevent GDM but helped to manage GWG appropriately and improved pregnancy outcomes. This trial was registered on 27 October, 2019, with initial participant enrollment on 5 May, 2020 at ChiCTR as 1900026963 (https://www.chictr.org.cn/searchproj.html?regno=1900026963).
背景
妊娠期糖尿病（GDM）影响着数百万女性及其子女。早期预防的有效饮食策略存在争议。
目的
本研究旨在调查个体化营养干预是否能降低高危女性的GDM发病率。
方法
在中国上海的3家三级医院进行了一项随机试验。我们将通过预测模型确定为GDM高危的孕早期女性随机（1:1）分为个体化营养干预组或常规护理组。干预措施包括在妊娠24 - 28周口服葡萄糖耐量试验（OGTT）前，由营养师根据中国膳食指南进行3次饮食咨询。对照组接受常规护理。所有参与者在每次随访时提供3天的食物记录。主要结局是采用国际糖尿病与妊娠研究组标准的GDM发病率。关键次要结局包括饮食改变、孕期体重增加（GWG）、母体代谢指标、围产期和妊娠结局。进行意向性分析。
结果
共纳入519名女性，其中261名被分配到干预组，258名接受常规护理。干预组85/245（34.7%）的女性被诊断为GDM，而对照组为89/244（36.5%）[调整后相对风险0.91（95%置信区间：0.73，1.15），P = 0.44]。干预组中孕期体重增加适宜的女性比对照组多[1.38（1.06，1.79）]，且OGTT期间空腹和2小时胰岛素水平较低（P < 0.001）。与对照组相比，我们观察到干预组小于胎龄儿发生率降低[0.11（0.01，0.80）]和新生儿低血糖发生率降低[0.14（0.04，0.57）]。
结论
在有GDM风险的女性中，在OGTT前根据中国膳食指南进行的个体化营养干预虽未预防GDM，但有助于适当控制孕期体重增加并改善妊娠结局。该试验于2019年10月27日注册，2020年5月5日在ChiCTR首次招募参与者，注册号为1900026963（https://www.chictr.org.cn/searchproj.html?regno=1900026963）。
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