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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• Aged 18-50 years;

• The risk for GDM includes overweight or obesity (BMI ≥ 24 kg/m2 before pregnancy), first-degree relative with diabetes, history of cardiovascular disease, hypertension (≥130/80 mmHg or on therapy for hypertension), HDL cholesterol level \< 1 mmol/L and/or a triglyceride level \> 2.8 mmol/L, history of GDM, history of macrosomia delivery, individuals with polycystic ovary syndrome, repeated positive fasting urine glucose in the first trimester, or age\>45 years according to Guideline of Diagnosis and Treatment of Hyperglycemia in Pregnancy (2022);

• Less than 14 weeks of gestation;

• Able to read and complete questionnaires in Chinese;

• singleton pregnancy.

Locations
Other Locations
China
Obstetrics and Gynecology Hospital of Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Ying Zhao, PhD
zhaoying7662@163.com
13061860396
Time Frame
Start Date: 2024-04-17
Estimated Completion Date: 2026-12
Participants
Target number of participants: 240
Treatments
Experimental: TRE(Time-restricted eating group)
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).
No_intervention: SOC (standard of care group)
Participants in the SOC group will be instructed to consume prescribed calories following habitual daily eating schedule over 3 months.
Related Therapeutic Areas
Sponsors
Collaborators: Shenzhen Maternity & Child Healthcare Hospital
Leads: Fudan University

This content was sourced from clinicaltrials.gov