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| Name | Class |
|---|---|
| Shenzhen Maternity & Child Healthcare Hospital | OTHER |
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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 .
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 about 26 gestational weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of GDM | Diagnosed by the 75g oral glucose tolerance test (OGTT). | 26 gestational weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of newborns with macrosomia | Number of newborns with birth weight ≥4000g. | At delivery |
| Number of newborns with low birth weight | Number of newborns with birth weight <2500g. |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to the intervention | Adherence to the intervention measure by Chinese Dietary Guidelines Compliance Index for Pregnant Women (CDGCI-PW) and by counting the number of days in which participants consumed calories outside the time-window or exceeding the upper limit of the required energy intake. Chinese Dietary Guidelines Compliance Index for Pregnant Women (CDGCI-PW): Scores range from 0-100, with higher score indicating better adherence. |
Inclusion criteria:
Exclusion criteria:
Exit criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Zhao, PhD | Contact | 13061860396 | zhaoying7662@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Obstetrics and Gynecology Hospital of Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200011 | China |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D005247 | Feeding Behavior |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| At delivery |
| Number of newborns large for gestational age (LGA) | Number of newborns with weight lies above the 90th percentile for the gestational age. | At delivery |
| Number of newborns small for gestational age (SGA) | Number of newborns with weight lies below the 10th percentile for the gestational age. | At delivery |
| Incidence of shoulder dystocia | The incidence of the condition in which normal traction on the fetal head does not lead to the delivery of the shoulders. | At delivery |
| Number of newborns with birth injury | Number of newborns with an impairment of the neonate's body function or structure due to an adverse event that occurred at birth. | At delivery |
| Number of neonatus with neonatal intensive care unit (NICU) admission | Number of neonatus with neonatal intensive care unit (NICU) admission. | Within the first 28 days after delivery |
| Number of neonatus with neonatal respiratory distress | 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. | Within the first 28 days after delivery |
| Number of neonatus with hypoglycemia | Number of neonatus with venous glucose levels <2.6mmol/L. | Within the first 48 hours after delivery |
| Number of neonatus with pathologic jaundice | Jaundice that arises from factors that alter the usual process involved in bilirubin metabolism in the liver that requires treatment. | Within the first 28 days after delivery |
| Number of neonatus with intraventricular hemorrhage (IVH) of II grade or above | Intraventricular hemorrhage (IVH) of II grade or above diagnosed by ultrasound. | Within the first 28 days after delivery |
| Number of neonatus with necrotizing enterocolitis (NEC) | Necrotizing enterocolitis (NEC) diagnosed by radiography or surgery. | Within the first 28 days after delivery |
| Number of neonatus managed with assisted ventilation >24 hours via endotracheal tube. | Number of neonatus managed with assisted ventilation >24 hours via endotracheal tube. | Within 72 hours of birth |
| Number of neonatus with sepsis. | Number of neonatus with septicemia ascertained by blood culture. | Within the first 28 days after delivery |
| The incidence of neonatal death. | The incidence of deaths among live births during the first 28 completed days of life. | Within the first 28 days after delivery |
| The level of maternal fasting plasma insulin | Maternal fasting plasma insulin level. | at 24-28 gestational weeks |
| The level of maternal HbA1c | Maternal venous glycosylated hemoglobin A1c (HbA1c) level. | at 24-28 gestational weeks |
| Insulin resistance calculated by homeostatic model assessment (HOMA-IR) | 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. | at 24-28 gestational weeks |
| Maternal lipid profile | Level of maternal venous low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides and total cholesterol. | at 24-28 gestational weeks |
| Maternal change in depression, quality of sleep and quality of life | 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. | From pre-pregnancy to 24-28 gestational weeks |
| Gestational weight gain | Measured according to pre-pregnancy weight and weight at 24-28 gestational weeks. | From pre-pregnancy to 24-28 gestational weeks |
| Change in waist circumference | Measured according to pre-pregnancy waist circumference and waist circumference at 24-28 gestational weeks. | From pre-pregnancy to 24-28 gestational weeks |
| Incidence of maternal morbidities | Incidence of hypertensive disorders of pregnancy, hydramnios, placental abruption, preterm/prelabor rupture of membranes (P/PROM), preterm birth, chorioamnionitis, postpartum hemorrhage and still birth. | From 24-28 gestational weeks to delivery |
| From 14-26 gestational weeks |
| D044882 | Glucose Metabolism Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001522 | Behavior, Animal |
| D001519 | Behavior |