TY - JOUR
T1 - Effect of an individualised nutritional intervention on gestational diabetes mellitus prevention in a high-risk population screened by a prediction model
T2 - study protocol for a multicentre randomised controlled trial
AU - Zhang, Chenjie
AU - Wang, Lulu
AU - Sun, Wenguang
AU - Chen, Lei
AU - Zhang, Chen
AU - Li, Hong
AU - Yu, Jiale
AU - Fan, Jianxia
AU - Ruan, Huijuan
AU - Zheng, Tao
AU - Wu, Dongling
AU - Li, Shaojing
AU - Lu, Huan
AU - Wang, Man
AU - Mol, Ben W.
AU - Huang, Hefeng
AU - Wu, Yanting
N1 - Funding Information:
This clinical trial received funding from the Clinical Technology Innovation Project of Shanghai Shenkang Hospital Development Centre (SHDC12019107, SHDC12018X17), Program of Shanghai Academic Research Leader (20XD1424100), Outstanding Youth Medical Talents of Shanghai Rising Stars of Medical Talent Youth Development Program, the International Science and Technology Collaborative Fund of Shanghai (18410711800), the Foundation of Shanghai Municipal Commission of Health and Family Planning (201840210), the Natural Science Foundation of Shanghai (20ZR1463100), the National Natural Science Foundation of China (81671412, 81661128010), and CAMS Innovation Fund for Medical Sciences (2019-12 M-5-064).
Publisher Copyright:
© 2021, The Author(s).
Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/12
Y1 - 2021/12
N2 - 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.
AB - 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.
KW - Gestational diabetes mellitus
KW - Nutritional interventions
KW - Prediction model
KW - Randomised controlled trial
KW - Study protocol
KW - Three-day food records
UR - http://www.scopus.com/inward/record.url?scp=85113295563&partnerID=8YFLogxK
U2 - 10.1186/s12884-021-04039-2
DO - 10.1186/s12884-021-04039-2
M3 - Article
C2 - 34429102
AN - SCOPUS:85113295563
SN - 1471-2393
VL - 21
JO - BMC Pregnancy and Childbirth
JF - BMC Pregnancy and Childbirth
IS - 1
M1 - 586
ER -