The Effect of Early Nutrition Intervention on the Incidence of High-risk Patients With Gestational Diabetes

Not Applicable

• Conditions: Gestational Diabetes
• Interventions: Behavioral: The low-GI diet and muscle training

• Registration Number: NCT03550976
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

The incidence of gestational diabetes increased.The multidisciplinary management of GDM during pregnancy is helpful to improve the pregnancy outcome, but it will occupy huge medical resources.Early prediction, diet and exercise interventions can reduce the incidence of gestational diabetes, but there is no reliable way to predict and intervene early.This study is a randomized controlled trials, and aims to use comprehensive prediction method (genetic screening, body composition, clinical risk factors screening) screening the subjects with high GDM risk in early pregnancy, conducting diet and exercise intervention in second trimester and observing the effect on the incidence of GDM and perinatal outcomes.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-29
• Study First Submitted QC: 2018-05-29
• Study First Posted: 2018-06-11
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-06
• Last Update Posted: 2018-08-08
• Study Start: 2018-10-01
• Primary Completion: 2019-09-10
• Study Completion: 2020-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

• early pregnant women (< 12 weeks)

• fasting blood glucose < / = 5.6 mmol/L and glycosylated hemoglobin < / = 5.6%

• prepregnancy overweight (BMI > 23.9) or body fat content more than 30% (based on body composition analysis)

• no history of major diseases or long-term drug treatment

• no obvious physical disabilities, the ability of physical activity is normal

• dietary behavior and mental is normal

• resident in Beijing, early and middle stage pregnancy can be in Beijing area to receive regular obstetric examinations

• signed informed consent

• the following at least one

  • first-degree relatives family history of diabetes
  • history of abnormal lipid metabolism or abnormal lipid metabolism
  • history of polycystic ovary syndrome
  • history of large for gestational age infant or macrosomia deliver

Exclusion Criteria

• history of gestational diabetes mellitus
• clinical glucose metabolism abnormalities
• once taking diabetes drugs or insulin injections
• a variety of food allergies or food choices serious limitations
• exercise during pregnancy contraindication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High risk intervention group	The low-GI diet and muscle training	-

Primary Outcome Measures

Name	Time	Method
Incidence of gestational diabetes	12-28 weeks of pregnancy	The incidence of GDM was compared between the low-GI diet and the muscle training group, the high-risk control group and the low-risk control group.