Prevention of Gestational Diabetes

December 14, 2010 updated by: Kuopio University Hospital

Feasibility of a Lifestyle Intervention in Early Risk Pregnancy in Preventing Deterioration in Glucose Tolerance?

Gestational diabetes mellitus (GDM)is a major health problem

  • growing prevalence of obesity
  • the older age of pregnant women

A randomized controlled trial in 54 pregnant voluntary women at high risk for GDM.

  • feasibility of an early intervention
  • glucose tolerance at weeks 26-28

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. A 75-g oral glucose tolerance test (OGTT) was performed at weeks 8-12

    1. voluntary women in early pregnancy (n=96)

    2. 54 high risk mothers were randomized

      • lifestyle intervention group (n=27)
      • close follow-up (n=27)

  2. An OGTT was performed again at weeks 26-28

    • the lifestyle intervention group (n=27)
    • the close follow-up group (n=27)
    • other high-risk women of the early care group (n=42)who were not randomized

  3. An OGTT was also performed at weeks 26-28 in two neighboring municipalities

    • a standard care high-risk group(n=171)who did not undergo early intervention

  4. Primary outcomes

    • number of at risk participants developing GDM during pregnancy in the two arms

  5. Secondary outcomes

    • the effect of intervention on fetal growth

Study Type

Interventional

Enrollment (Actual)

440

Phase

  • Not Applicable

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • high risk for gestational diabetes
  • fasting glucose 4.8-5.5 mmol/l and 2-hour glucose of OGTT <7.8 mmol/l

Exclusion Criteria:

  • normal glucose tolerance at weeks 8-12
  • gestational diabetes at weeks 8-12

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Lifestyle, follow-up, early care, standard care high/low risk
Lifestyle: The women received counseling by a clinical nutritionist six times and by a physiotherapist six times during pregnancy.
Behavioral: Lifestyle: diet and exercise
Lifestyle: The women received counseling by a clinical nutritionist six times and by a physiotherapist six times during pregnancy.
Other: Close follow-up
Follow-up: The women received information of the results of a glucose tolerance test (OGTT), reported food records three times during pregnancy, exercise history and exercise diaries monthly.
Behavioral: Close follow-up: reporting diaries of food and exercise
Follow-up: The women received information of the results of a glucose tolerance test (OGTT), reported food records three times during pregnancy, exercise history and exercise diaries monthly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Number of at risk participants developing GDM during pregnancy

Secondary Outcome Measures

Outcome Measure
The effect of intervention on fetal growth

Collaborators and Investigators

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

Sponsor

Kuopio University Hospital

Collaborators

South Ostrobothnia Hospital District

Investigators

  • Principal Investigator: Eeva Korpi-Hyövälti, MD, South Ostrobothnia Hospital District

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2005

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

May 11, 2010

First Submitted That Met QC Criteria

May 24, 2010

First Posted (Estimate)

May 25, 2010

Study Record Updates

Last Update Posted (Estimate)

December 15, 2010

Last Update Submitted That Met QC Criteria

December 14, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUH16032005

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.

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