The Effect of Early Nutrition Intervention on the Incidence of High-risk Patients With Gestational Diabetes
Primary Purpose
Gestational Diabetes
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
The low-GI diet and muscle training
Sponsored by
About this trial
This is an interventional prevention trial for Gestational Diabetes
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
No Intervention
Arm Label
High risk intervention group
High risk control group
Low risk control group
Arm Description
Dietary evaluation and body composition analysis at 12 and 28 weeks of pregnancy. Receive routine obstetric examinations and routine health education which includes proper diet and exercise advice.Collect birth outcomes.
Dietary evaluation and body composition analysis at 12 and 28 weeks of pregnancy. Receive routine obstetric examinations and routine health education which includes proper diet and exercise advice.Collect birth outcomes.
Outcomes
Primary Outcome Measures
Incidence of gestational diabetes
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03550976
First Posted
May 29, 2018
Last Updated
August 6, 2018
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03550976
Brief Title
The Effect of Early Nutrition Intervention on the Incidence of High-risk Patients With Gestational Diabetes
Official Title
The Effect of Early Nutrition Intervention on the Incidence of High-risk Patients With Gestational Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Anticipated)
Primary Completion Date
September 10, 2019 (Anticipated)
Study Completion Date
June 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High risk intervention group
Arm Type
Experimental
Arm Title
High risk control group
Arm Type
No Intervention
Arm Description
Dietary evaluation and body composition analysis at 12 and 28 weeks of pregnancy. Receive routine obstetric examinations and routine health education which includes proper diet and exercise advice.Collect birth outcomes.
Arm Title
Low risk control group
Arm Type
No Intervention
Arm Description
Dietary evaluation and body composition analysis at 12 and 28 weeks of pregnancy. Receive routine obstetric examinations and routine health education which includes proper diet and exercise advice.Collect birth outcomes.
Intervention Type
Behavioral
Intervention Name(s)
The low-GI diet and muscle training
Intervention Description
During the 12-28 weeks of pregnancy, the pregnant women received low-GI diet and exercise intervention.Every two weeks, the pregnant women were followed up to assess the dietary situation and analyze the body composition results.Collect birth outcomes
Primary Outcome Measure Information:
Title
Incidence of gestational diabetes
Description
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.
Time Frame
12-28 weeks of pregnancy
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanpin Liu, bachelor
Phone
+861069159088
Email
liuyp1227@vip.sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yixuan Hou, master
Phone
+8618810112590
Email
15612494030@163.com
12. IPD Sharing Statement
Learn more about this trial
The Effect of Early Nutrition Intervention on the Incidence of High-risk Patients With Gestational Diabetes
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