Primary prevention of gestational diabetes among women at risk: a cluster-randomized controlled trial
Completed
- Conditions
- Pregnancy and ChildbirthGestational diabetes
- Registration Number
- ISRCTN33885819
- Lead Sponsor
- The Urho Kaleva Kekkonen (UKK) Institute for Health Promotion Research (Finland)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 600
Inclusion Criteria
Pregnant women in their 8-12th pregnancy week and with at least one of the following criteria:
1. Body mass index at least 25 kg/m2
2. Age at least 40 years
3. History of gestational diabetes or macrosomic child
4. Type 1 or 2 diabetes in any of the first stage relatives
Exclusion Criteria
1. Age < 18 years
2. Type 1 or 2 diabetes before pregnancy
3. Twin pregnancy or otherwise problematic pregnancy based on physician's opinion
4. Physical disability preventing from exercising
5. Substance abuse or history of severe mental illness
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prevention of gestational diabetes, assessed by: <br>1. Oral glucose tolerance test during pregnancy weeks 26-28<br>2. Weight of the newborn
- Secondary Outcome Measures
Name Time Method 1. Maternal weight development. Maternal weight will be measured 5 times during pregnancy, on pregnancy weeks 8-9, 16-18, 22-24, 32-34 and 36-37, and 6-8 weeks after delivery.<br>2. Child weight development, followed one year after delivery. <br>3. Need of insulin treatment during pregnancy. This will be determined at time of possible GDM diagnosis (earliest 26-28th week of pregnancy based on Oral Glucose Tolerance Test [OGTT]).