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

NCT06431997 | Recruiting

• 1 other identifier: FD153502
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

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

Keywords

Gestational Diabetes Mellitus; Metabolic Diseases

Outcome Measures

Primary Outcomes (1)

• The incidence of GDM

  Diagnosed by the 75g oral glucose tolerance test (OGTT).

  26 gestational weeks

Secondary Outcomes (23)

• Number of newborns with macrosomia

  At delivery

• Number of newborns with low birth weight

  At delivery

• Number of newborns large for gestational age (LGA)

  At delivery

• Number of newborns small for gestational age (SGA)

  At delivery

• Incidence of shoulder dystocia

  At delivery

Other Outcomes (1)

• Adherence to the intervention

  From 14-26 gestational weeks

Study Arms (2)

TRE(Time-restricted eating group)

EXPERIMENTAL

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).

Behavioral: Time-limited eating

SOC (standard of care group)

NO INTERVENTION

Participants in the SOC group will be instructed to consume prescribed calories following habitual daily eating schedule over 3 months.

Interventions

Time-limited eating BEHAVIORAL

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.

TRE(Time-restricted eating group)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Pregestational diabetes (including diabetes diagnosed before conception; fasting blood glucose ≥ 7.0 mmol/L or HbA1c ≥ 6.5% in the first trimester; typical symptoms of hyperglycemia or hyperglycemic crisis with optional blood glucose ≥ 11.1 mmol/L);
• Impaired glucose tolerance (including fasting blood glucose ≥ 5.6 mmol/L or two fasting blood glucose ≥ 5.1 mmol/L in the first trimester);
• Current or recent use of drugs that affect glucose metabolism such as metformin, glucocorticoids and Orlistat;
• Severe comorbidities (including cardiac diseases, kidney diseases, hepatopathy, autoimmune diseases, uncontrolled thyroid disease, previous or current malignant tumors, etc.);
• Fetal malformations or chromosomal abnormalities;
• Cervical insufficiency (including ultrasonic cervical length \< 25 mm before 24 weeks of gestation, history of spontaneous preterm birth at 14-36 weeks of previous pregnancy, or cervical dilation in the past or current pregnancy);
• Exercise contraindications (including continuous vaginal bleeding, threatened premature labor, placenta previa, premature rupture of membranes, severe anemia, etc.);
• Drug abuse, which refers to the repetitive, heavy use of drugs with dependent characteristics such as narcotic, psychotropic substances, tobacco and alcohol;
• Hyperemesis gravidarum, which refers to the severe and persistent nausea and vomiting, unable to eat or eat little that leads to dehydration, ketosis and even acidosis;
• On a special or prescribed diet for other reasons;
• Eating window\<10 h.
• Exit criteria：
• Failure to comply with or assume the corresponding responsibilities and obligations of the informed agreement;
• Pregnant women who terminate their pregnancy before completing GDM diagnosis and screening at 24-28 weeks of pregnancy will automatically withdraw from the group, such as severe fetal malformation, eclampsia, abortion, etc.
• Major diseases, such as particularly serious obstetric medical events, malignant tumors, serious cardiovascular and cerebrovascular diseases, brain injuries, paralysis and other major diseases, can not continue to accept this intervention plan and follow-up, and withdraw from the study;

Sponsors & Collaborators

• Fudan University: lead
• Shenzhen Maternity & Child Healthcare Hospital: collaborator

Study Sites (1)

Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational; Feeding Behavior; Metabolic Diseases

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior, Animal; Behavior

Central Study Contacts

Ying Zhao, PhD

CONTACT

13061860396; zhaoying7662@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: May 29, 2024
• Study Start: April 17, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-04

Locations

CN (1)