Prevention of Gestational Diabetes
Primary Purpose
Gestational Diabetes
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lifestyle: diet and exercise
Close follow-up: reporting diaries of food and exercise
Sponsored by
About this trial
This is an interventional prevention trial for Gestational Diabetes focused on measuring Gestational diabetes mellitus, Lifestyle intervention, Oral glucose tolerance test, Insulin treatment, Pregnancy outcomes
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Lifestyle, follow-up, early care, standard care high/low risk
Close follow-up
Arm Description
Lifestyle: The women received counseling by a clinical nutritionist six times and by a physiotherapist six times during pregnancy.
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.
Outcomes
Primary Outcome Measures
Number of at risk participants developing GDM during pregnancy
Secondary Outcome Measures
The effect of intervention on fetal growth
Full Information
NCT ID
NCT01130012
First Posted
May 11, 2010
Last Updated
December 14, 2010
Sponsor
Kuopio University Hospital
Collaborators
South Ostrobothnia Hospital District
1. Study Identification
Unique Protocol Identification Number
NCT01130012
Brief Title
Prevention of Gestational Diabetes
Official Title
Feasibility of a Lifestyle Intervention in Early Risk Pregnancy in Preventing Deterioration in Glucose Tolerance?
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Kuopio University Hospital
Collaborators
South Ostrobothnia Hospital District
4. Oversight
5. Study Description
Brief 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
A 75-g oral glucose tolerance test (OGTT) was performed at weeks 8-12
voluntary women in early pregnancy (n=96)
54 high risk mothers were randomized
lifestyle intervention group (n=27)
close follow-up (n=27)
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
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
Primary outcomes
number of at risk participants developing GDM during pregnancy in the two arms
Secondary outcomes
the effect of intervention on fetal growth
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
Keywords
Gestational diabetes mellitus, Lifestyle intervention, Oral glucose tolerance test, Insulin treatment, Pregnancy outcomes
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
440 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle, follow-up, early care, standard care high/low risk
Arm Type
Other
Arm Description
Lifestyle: The women received counseling by a clinical nutritionist six times and by a physiotherapist six times during pregnancy.
Arm Title
Close follow-up
Arm Type
Other
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle: diet and exercise
Intervention Description
Lifestyle: The women received counseling by a clinical nutritionist six times and by a physiotherapist six times during pregnancy.
Intervention Type
Behavioral
Intervention Name(s)
Close follow-up: reporting diaries of food and exercise
Intervention 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.
Primary Outcome Measure Information:
Title
Number of at risk participants developing GDM during pregnancy
Secondary Outcome Measure Information:
Title
The effect of intervention on fetal growth
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eeva Korpi-Hyövälti, MD
Organizational Affiliation
South Ostrobothnia Hospital District
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
22898328
Citation
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.
Results Reference
derived
PubMed Identifier
21429234
Citation
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.
Results Reference
derived
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Prevention of Gestational Diabetes
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