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

NARecruitingINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

April 17, 2024

Primary Completion Date

January 31, 2026

Study Completion Date

December 31, 2026

Conditions
Gestational Diabetes MellitusDietary HabitsLifestyle InterventionRandomized Controlled Study
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.

Trial Locations (1)

200011

RECRUITING

Obstetrics and Gynecology Hospital of Fudan University, Shanghai

All Listed Sponsors
collaborator

Shenzhen Maternity & Child Healthcare Hospital

OTHER

lead

Fudan University

OTHER