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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
Kuopio University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts 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

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

    First Posted
    May 11, 2010
    Last Updated
    December 14, 2010
    Sponsor
    Kuopio University Hospital
    Collaborators
    South Ostrobothnia Hospital District
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    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

    Learn more about this trial

    Prevention of Gestational Diabetes

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