Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
440 participants
INTERVENTIONAL
2005-04-30
2006-12-31
Brief Summary
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* 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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Lifestyle, follow-up, early care, standard care high/low risk
Lifestyle: The women received counseling by a clinical nutritionist six times and by a physiotherapist six times during pregnancy.
Lifestyle: diet and exercise
Lifestyle: The women received counseling by a clinical nutritionist six times and by a physiotherapist six times during pregnancy.
Close follow-up
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.
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.
Interventions
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Lifestyle: diet and exercise
Lifestyle: The women received counseling by a clinical nutritionist six times and by a physiotherapist six times during pregnancy.
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.
Eligibility Criteria
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Inclusion Criteria
* fasting glucose 4.8-5.5 mmol/l and 2-hour glucose of OGTT \<7.8 mmol/l
Exclusion Criteria
* gestational diabetes at weeks 8-12
FEMALE
Yes
Sponsors
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South Ostrobothnia Hospital District
UNKNOWN
Kuopio University Hospital
OTHER
Responsible Party
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Kuopio University Hospital
Principal Investigators
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Eeva Korpi-Hyövälti, MD
Role: PRINCIPAL_INVESTIGATOR
South Ostrobothnia Hospital District
References
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Korpi-Hyovalti E, Heinonen S, Schwab U, Laaksonen DE, Niskanen L. Effect of intensive counselling on physical activity in pregnant women at high risk for gestational diabetes mellitus. A clinical study in primary care. Prim Care Diabetes. 2012 Dec;6(4):261-8. doi: 10.1016/j.pcd.2012.07.004. Epub 2012 Aug 13.
Korpi-Hyovalti EA, Laaksonen DE, Schwab US, Vanhapiha TH, Vihla KR, Heinonen ST, Niskanen LK. Feasibility of a lifestyle intervention in early pregnancy to prevent deterioration of glucose tolerance. BMC Public Health. 2011 Mar 24;11:179. doi: 10.1186/1471-2458-11-179.
Other Identifiers
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KUH16032005
Identifier Type: -
Identifier Source: org_study_id