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Primary prevention of gestational diabetes among women at risk: a cluster-randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN33885819
Enrollment
600
Registered
2007-10-03
Start date
2007-09-15
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational diabetes Pregnancy and Childbirth Gestational diabetes

Interventions

14 counties are participating in the trial. They are randomised to the intervention and control groups (7 counties each). Intervention group: Intensified, tailored diet and physical activity counsel

Sponsors

The Urho Kaleva Kekkonen (UKK) Institute for Health Promotion Research (Finland)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Prevention of gestational diabetes, assessed by: 1. Oral glucose tolerance test during pregnancy weeks 26-28 2. Weight of the newborn

Secondary

MeasureTime frame
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. 2. Child weight development, followed one year after delivery. 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]).

Countries

Finland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 29, 2026