The Effect of Early Nutrition Intervention on the Incidence of High-risk Patients With Gestational Diabetes
1 other identifier
interventional
400
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2018
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2018
CompletedFirst Posted
Study publicly available on registry
June 11, 2018
CompletedStudy Start
First participant enrolled
October 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedAugust 8, 2018
August 1, 2018
11 months
May 29, 2018
August 6, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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.
12-28 weeks of pregnancy
Study Arms (3)
High risk intervention group
EXPERIMENTALHigh risk control group
NO INTERVENTIONDietary 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.
Low risk control group
NO INTERVENTIONDietary 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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
May 29, 2018
First Posted
June 11, 2018
Study Start
October 1, 2018
Primary Completion
September 10, 2019
Study Completion
June 1, 2020
Last Updated
August 8, 2018
Record last verified: 2018-08