Feasibility of a Lifestyle Intervention in Early Risk Pregnancy in Preventing Deterioration in Glucose Tolerance?
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gestational Diabetes
- Sponsor
- Kuopio University Hospital
- Enrollment
- 440
- Primary Endpoint
- Number of at risk participants developing GDM during pregnancy
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
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
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
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of at risk participants developing GDM during pregnancy
Secondary Outcomes
- The effect of intervention on fetal growth