A Study of the Intervention of Time-restricted Eating in High-risk Populations of GDM
- Conditions
- Randomized Controlled StudyDietary HabitsGestational Diabetes MellitusLifestyle Intervention
- Interventions
- Behavioral: Time-limited eating
- Registration Number
- NCT06431997
- Lead Sponsor
- Fudan University
- 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 under the same energy intake.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 240
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TRE(Time-restricted eating group) Time-limited eating 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).
- Primary Outcome Measures
Name Time Method The incidence of GDM 24-28 gestational weeks Diagnosed by the 75g oral glucose tolerance test (OGTT).
- Secondary Outcome Measures
Name Time Method Number of neonatus with hypoglycemia Within the first 48 hours after delivery Number of neonatus with venous glucose levels \<2.6mmol/L.
Number of newborns with low birth weight At delivery Number of newborns with birth weight \<2500g.
Number of neonatus with neonatal intensive care unit (NICU) admission Within the first 28 days after delivery Number of neonatus with neonatal intensive care unit (NICU) admission.
Number of newborns large for gestational age (LGA) At delivery Number of newborns with weight lies above the 90th percentile for the gestational age.
Number of newborns with birth injury At delivery Number of newborns with an impairment of the neonate's body function or structure due to an adverse event that occurred at birth.
Number of neonatus with neonatal respiratory distress Within the first 28 days after delivery Number of neonatus with clinical symptoms including tachypnea, nasal flaring, grunting, retractions (subcostal, intercostal, supracostal, jugular), cyanosis, apnea, bradypnea, irregular breathing, inspiratory stridor, wheeze and hypoxia, etc.
Incidence of shoulder dystocia At delivery The incidence of the condition in which normal traction on the fetal head does not lead to the delivery of the shoulders.
Number of neonatus with pathologic jaundice Within the first 28 days after delivery Jaundice that arises from factors that alter the usual process involved in bilirubin metabolism in the liver that requires treatment.
Number of neonatus with intraventricular hemorrhage (IVH) of II grade or above Within the first 28 days after delivery Intraventricular hemorrhage (IVH) of II grade or above diagnosed by ultrasound.
Number of newborns small for gestational age (SGA) At delivery Number of newborns with weight lies below the 10th percentile for the gestational age.
The incidence of neonatal death. Within the first 28 days after delivery The incidence of deaths among live births during the first 28 completed days of life.
Maternal change in depression, quality of sleep and quality of life From pre-pregnancy to 24-28 gestational weeks Maternal change in depression, quality of sleep and quality of life measured by the Patient Health Questionnaire-9 (PHQ-9), Pittsburgh sleep quality index (PSQI) and 12-item Short-Form Health Survey Questionnaire (SF-12) according to pre-pregnancy status and 24-28 gestational weeks.
The Patient Health Questionnaire-9 (PHQ-9): Scores range from 0 to 27, with higher scores indicating severer depression. The standard cut-off score for screening to identify possible major depression is 10 or above.
Pittsburgh sleep quality index (PSQI): Scores range from 0 to 21, with higher scores indicating worse sleep quality.
12-item Short-Form Health Survey Questionnaire (SF-12): physical component score (PCS) range from 0 to 100, higher scores are better.Number of neonatus with sepsis. Within the first 28 days after delivery Number of neonatus with septicemia ascertained by blood culture.
Insulin resistance calculated by homeostatic model assessment (HOMA-IR) at 24-28 gestational weeks Insulin resistance calculated by homeostatic model assessment (HOMA-IR). HOMA-IR=fasting plasma glucose (FPG)× fasting plasma insulin (FINS)/22.5. The higher HOMA-IR value indicates higher severity of insulin resistance.
Change in waist circumference From pre-pregnancy to 24-28 gestational weeks Measured according to pre-pregnancy waist circumference and waist circumference at 24-28 gestational weeks.
Incidence of maternal morbidities From 24-28 gestational weeks to delivery Incidence of hypertensive disorders of pregnancy, hydramnios, placental abruption, preterm/prelabor rupture of membranes (P/PROM), preterm birth, chorioamnionitis, postpartum hemorrhage and still birth.
Number of neonatus with necrotizing enterocolitis (NEC) Within the first 28 days after delivery Necrotizing enterocolitis (NEC) diagnosed by radiography or surgery.
Number of neonatus managed with assisted ventilation >24 hours via endotracheal tube. Within 72 hours of birth Number of neonatus managed with assisted ventilation \>24 hours via endotracheal tube.
The level of maternal fasting plasma insulin at 24-28 gestational weeks Maternal fasting plasma insulin level.
The level of maternal HbA1c at 24-28 gestational weeks Maternal venous glycosylated hemoglobin A1c (HbA1c) level.
Maternal lipid profile at 24-28 gestational weeks Level of maternal venous low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides and total cholesterol.
Gestational weight gain From pre-pregnancy to 24-28 gestational weeks Measured according to pre-pregnancy weight and weight at 24-28 gestational weeks.
Number of newborns with macrosomia At delivery Number of newborns with birth weight ≥4000g.
Trial Locations
- Locations (1)
Obstetrics and Gynecology Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China