NCT01130012

Prevention of Gestational Diabetes

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 440 (actual)
• Sponsor: Kuopio University Hospital · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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

Conditions

• Gestational Diabetes

Interventions

Type	Name	Description
BEHAVIORAL	Lifestyle: diet and exercise	Lifestyle: The women received counseling by a clinical nutritionist six times and by a physiotherapist six times during pregnancy.
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.

Timeline

• Start date: 2005-04-01
• Primary completion: 2006-05-01
• Completion: 2006-12-01
• First posted: 2010-05-25
• Last updated: 2010-12-15