NCT06431997

A Study of the Intervention of Time-restricted Eating in High-risk Populations of GDM

Effects of Time-restricted Eating on the Incidence of Gestational Diabetes Mellitus in High-risk Populations: a Randomized Controlled Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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 .

Detailed description

Investigators present a multicenter, open-label and parallel-group randomized study. Total 240 women in early pregnancy were randomly assigned to TRE group and SOC (standard of care) group according to the ratio of 1: 1. 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. All participants should follow moderate-intensity physical activity for about 30 minutes every day, and receive diet and exercise counseling during the study period. GDM was diagnosed by 75g oral glucose tolerance test (OGTT) test at about 26 gestational weeks.

Conditions

• Gestational Diabetes Mellitus
• Dietary Habits
• Lifestyle Intervention
• Randomized Controlled Study

Interventions

Type	Name	Description
BEHAVIORAL	Time-limited eating	All 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.

Timeline

• Start date: 2024-04-17
• Primary completion: 2026-01-01
• Completion: 2026-12-01
• First posted: 2024-05-29
• Last updated: 2025-11-21

Locations

1 site across 1 country: China