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RECRUITING
NCT06431997
NA

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

Sponsor: Fudan University

View on ClinicalTrials.gov

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 .

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

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2024-04-17

Completion Date

2026-12

Last Updated

2025-11-21

Healthy Volunteers

No

Interventions

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.

Locations (1)

Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, China