Prevention of Gestational Diabetes

Kuopio University Hospital

Status: Completed

Conditions: Gestational Diabetes

Treatments: Behavioral: Close follow-up: reporting diaries of food and exercise; Behavioral: Lifestyle: diet and exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT01130012

KUH16032005

Details and patient eligibility

About

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

Full 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

Enrollment: 440 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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440 participants in 2 patient groups

Lifestyle, follow-up, early care, standard care high/low risk

Other group

Description:

Lifestyle: The women received counseling by a clinical nutritionist six times and by a physiotherapist six times during pregnancy.

Treatment:

Behavioral: Lifestyle: diet and exercise

Close follow-up

Other group

Description:

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.

Treatment:

Behavioral: Close follow-up: reporting diaries of food and exercise