This is a randomized controlled trial, aiming to investigate whether a time-restricted eating (TRE) can reduce the incidence of gestational diabetes mellitus (GDM) in high-risk pregnant women. Investigators intend to conduct a 3-month randomized controlled study to compare the effects of 10-hour TRE and habitual eating time on GDM .
Aged 18-50 years;
The risk for GDM includes overweight or obesity (BMI ≥ 24 kg/m2 before pregnancy), first-degree relative with diabetes, history of cardiovascular disease, hypertension (≥130/80 mmHg or on therapy for hypertension), HDL cholesterol level < 1 mmol/L and/or a triglyceride level > 2.8 mmol/L, history of GDM, history of macrosomia delivery, individuals with polycystic ovary syndrome, repeated positive fasting urine glucose in the first trimester, or age>45 years according to Guideline of Diagnosis and Treatment of Hyperglycemia in Pregnancy (2022);
Less than 14 weeks of gestation;
Able to read and complete questionnaires in Chinese;
Pregestational diabetes (including diabetes diagnosed before conception; fasting blood glucose ≥ 7.0 mmol/L or HbA1c ≥ 6.5% in the first trimester; typical symptoms of hyperglycemia or hyperglycemic crisis with optional blood glucose ≥ 11.1 mmol/L);
Impaired glucose tolerance (including fasting blood glucose ≥ 5.6 mmol/L or two fasting blood glucose ≥ 5.1 mmol/L in the first trimester);
Current or recent use of drugs that affect glucose metabolism such as metformin, glucocorticoids and Orlistat;
Severe comorbidities (including cardiac diseases, kidney diseases, hepatopathy, autoimmune diseases, uncontrolled thyroid disease, previous or current malignant tumors, etc.);
Parallel
Time-limited eating
BehavioralAll participants will be instructed to follow a diet of 1800-2200 kcal/d (45-50% of energy from carbohydrate, 15-20% from protein, 25-30% from fat) based primarily on Dietary Guidelines for Chinese Residents (2022), Dietary guidelines for pregnant women and Guideline of Diagnosis and Treatment of Hyperglycemia in Pregnancy (2022). Participants assigned to the TRE group will be instructed to consume prescribed calories in a 10-hour eating window (from 8:30 am to 18:30 pm) each day and only noncaloric beverages were permitted outside of the eating window over 3 months (from 14-26 gestational weeks). Participants in the SOC group will be instructed to consume prescribed calories following habitual daily eating schedule over 3 months.
The incidence of GDM
Diagnosed by the 75g oral glucose tolerance test (OGTT).
Number of newborns with macrosomia
Number of newborns with birth weight ≥4000g.
Number of newborns with low birth weight
Number of newborns with birth weight \<2500g.
Number of newborns large for gestational age (LGA)
Number of newborns with weight lies above the 90th percentile for the gestational age.
Number of newborns small for gestational age (SGA)
Number of newborns with weight lies below the 10th percentile for the gestational age.
Adherence to the intervention
Adherence to the intervention measure by Chinese Dietary Guidelines Compliance Index for Pregnant Women (CDGCI-PW) and by counting the number of days in which participants consumed calories outside the time-window or exceeding the upper limit of the required energy intake. Chinese Dietary Guidelines Compliance Index for Pregnant Women (CDGCI-PW): Scores range from 0-100, with higher score indicating better adherence.
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Fudan University
Lead sponsor
Obstetrics & Gynecology Hospital of Fudan University
Sponsor institution
Shenzhen Maternity & Child Healthcare Hospital
Collaborator
