Actively Recruiting
Effects of Time-restricted Eating on the Incidence of Gestational Diabetes Mellitus in High-risk Populations: a Randomized Controlled Study
Led by Fudan University · Updated on 2025-11-21
240
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
Sponsors
F
Fudan University
Lead Sponsor
S
Shenzhen Maternity & Child Healthcare Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether time-restricted eating (TRE) can lower the chance of gestational diabetes mellitus (GDM) in pregnant women at high risk. This study is a randomized controlled trial involving 240 women in early pregnancy. The goal is to compare the effects of eating within a 10-hour window versus following usual eating habits on the development of GDM over three months. Participants are randomly assigned to two groups. The TRE group will consume prescribed calories within a daily 10-hour window from 8:30 am to 6:30 pm, drinking only noncaloric beverages outside this time, during 14 to 26 weeks of pregnancy. The standard of care (SOC) group will eat the same calories but follow their usual eating schedules. Both groups will engage in about 30 minutes of moderate exercise daily and receive diet and exercise counseling throughout the study. During the study, all participants will undergo a 75g oral glucose tolerance test around 26 weeks to check for GDM. Researchers will measure the incidence of GDM and monitor various newborn outcomes at delivery and shortly after, including birth weight and health complications. Maternal blood tests, weight gain, mood, sleep, quality of life, and pregnancy-related health issues will also be tracked. The study lasts through pregnancy with detailed follow-up until delivery and shortly beyond.
CONDITIONS
Brief Title
A Study of the Intervention of Time-restricted Eating in High-risk Populations of GDM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 50 years
- At high risk for gestational diabetes due to factors like overweight before pregnancy (BMI 24 kg/m2), family history of diabetes, cardiovascular disease, hypertension, abnormal cholesterol or triglyceride levels, history of gestational diabetes or macrosomia, polycystic ovary syndrome, repeated positive fasting urine glucose in first trimester, or age over 45
- Less than 14 weeks pregnant
- Able to read and complete questionnaires in Chinese
- Pregnant with a single baby
You will not qualify if you...
- Pregestational diabetes diagnosed before pregnancy or fasting blood glucose 27 7.0 mmol/L or HbA1c 27 6.5% in first trimester
- Impaired glucose tolerance or elevated fasting blood glucose in first trimester
- Current or recent use of drugs affecting glucose metabolism such as metformin, glucocorticoids, or Orlistat
- Severe other illnesses including heart, kidney, liver diseases, autoimmune diseases, uncontrolled thyroid disease, or cancer
- Fetal malformations or chromosomal abnormalities
- Cervical insufficiency or history of preterm birth
- Exercise contraindications such as vaginal bleeding, threatened premature labor, placenta previa, premature rupture of membranes, severe anemia
- Drug abuse including narcotics, psychotropic substances, tobacco, and alcohol
- Severe nausea and vomiting causing dehydration or ketosis
- On a special or prescribed diet for other reasons
- Eating window less than 10 hours daily
- Withdrawal criteria include non-compliance, pregnancy termination before screening, major diseases preventing continued participation, accidental disability or death, or voluntary withdrawal by participant
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 months (from 14 to 26 gestational weeks)
Participants follow assigned eating schedules and receive diet and exercise counseling during pregnancy weeks 14 to 26. The Time-restricted eating group consumes calories within a 10-hour window daily, while the standard of care group follows their habitual eating schedule. Moderate-intensity physical activity is recommended daily.
Regular visits for counseling and assessments during the 3 months
Duration - 1 day
Participants undergo a 75g oral glucose tolerance test to diagnose gestational diabetes mellitus around 26 gestational weeks.
1 visit (in-person)
Duration - Up to 28 days after delivery
Participants and their newborns are monitored for health outcomes including birth weight, complications, and neonatal conditions up to 28 days after delivery.
Follow-up visits around delivery and within the first 28 days postpartum
Trial Site Locations
Total: 1 location
1
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200011
Actively Recruiting
Research Team
Y
Ying Zhao, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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