Effect of an individualised nutritional intervention on gestational diabetes mellitus prevention in a high-risk population screened by a prediction model: study protocol for a multicentre randomised controlled trial

BMC Pregnancy and Childbirth

Dongling Wu¹  Tao Zheng¹  Huijuan Ruan¹  Ben W. Mol²  Shaojing Li³  Huan Lu³  Man Wang³  Lei Chen⁴  Chenjie Zhang⁴  Jiale Yu⁴  Wenguang Sun⁴  Hong Li⁴  Yanting Wu⁴  Lulu Wang⁴  Hefeng Huang⁴  Jianxia Fan⁴  Chen Zhang⁵ 

[1] Department of Gynecology, Xinhua Hospital, Shanghai Jiao Tong University;Department of Obstetrics and Gynaecology, Monash University;Department of Obstetrics and Gynecology, Shanghai Jiao Tong University-Affiliated Sixth People’s Hospital of Fengxian Branch;International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University;Obstetrics and Gynecology Hospital, Institute of Reproduction and Development, Fudan University;

关键词: Study protocol;    Gestational diabetes mellitus;    Nutritional interventions;    Randomised controlled trial;    Prediction model;    Three-day food records;   

DOI  :  10.1186/s12884-021-04039-2

来源: DOAJ

【 摘 要 】

Abstract Background The ability of a preventive nutritional intervention to reduce the morbidity of gestational diabetes mellitus (GDM) remains controversial. We aim to assess whether GDM can be prevented by an individualised nutritional intervention in pregnant women who are at high risk for the disease based on a prediction model. Methods/design A multicentre randomised controlled trial was designed to assess the efficacy of an individualised nutritional intervention for the prevention of GDM in a high-risk population screened by a novel prediction model in the first trimester. Pregnant women evaluated to be at high risk for GDM by the prediction model at less than 14 gestational weeks will be included. Women with pre-existing chronic diseases, including pregestational diabetes, or who are currently prescribed medicines that affect glucose values will be excluded. Allocation to intervention/control at a ratio of 1:1 will be conducted by a computerized randomisation system. The intervention group will complete 3-day food records and receive 3 individualised nutritional consultations with professional dieticians before the oral glucose tolerance test. The primary intention of the intervention is to promote a long-term healthy dietary pattern and prevent excessive gestational weight gain throughout pregnancy. The control group will complete 3-day food records at designated gestational weeks and receive standard antenatal care according to local health care provisions. The primary outcome is the incidence of GDM according to the criteria of the International Association of Diabetes and Pregnancy Study Group (IADPSG). A sample of 464 participants will provide 80% power to detect a 30% reduction in GDM incidence (α = 0.05 two tailed, 10% dropout). A total of 500 participants will be recruited. Discussion To date, this is the first randomised controlled trial aimed to evaluate the protective effect of an individualised nutritional intervention against GDM based on a logistic regression prediction model. Eligibility is not limited to obese women or singleton pregnancies, as in previous studies. This pragmatic trial is expected to provide valuable information on early screening and effective GDM prevention methods. Trial registration number ChiCTR, ChiCTR1900026963 . Registered 27 October 2019.

【 授权许可】

Unknown