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

August 6, 2018 updated by: Liuyanping, Peking Union Medical College Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: High risk intervention group
Behavioral: The low-GI diet and muscle training
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
NO_INTERVENTION: High risk control group
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.
NO_INTERVENTION: Low risk control group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of gestational diabetes
Time Frame: 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.
12-28 weeks of pregnancy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 1, 2018

Primary Completion (ANTICIPATED)

September 10, 2019

Study Completion (ANTICIPATED)

June 1, 2020

Study Registration Dates

First Submitted

May 29, 2018

First Submitted That Met QC Criteria

May 29, 2018

First Posted (ACTUAL)

June 11, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 8, 2018

Last Update Submitted That Met QC Criteria

August 6, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • hs-1551

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gestational Diabetes

Clinical Trials on The low-GI diet and muscle training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe