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

Dietary Habits Clinical Trial

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

Clinical Trial 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 under the same energy intake.

Clinical Trial 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 24-28 gestational weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06431997
Study type Interventional
Source Fudan University
Contact Ying Zhao, PhD
Phone 13061860396
Email zhaoying7662@163.com
Status Not yet recruiting
Phase N/A
Start date June 2024
Completion date December 2026
View Details
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