Prevention of Diabetes Mellitus Type 2 in Women Post Gestational Diabetes Mellitus Diagnosis
NCT ID: NCT01480895
Last Updated: 2011-11-29
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
180 participants
INTERVENTIONAL
2007-03-31
2010-04-30
Brief Summary
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Appropriate changes in everyday diet and physical exercise may reduce the chances for future GDM and type 2 DM.
The investigators aim was to determine GDM frequency in the Negev area in Jewish and Bedouin populations and to construct a plan for follow up and reduce future problems by changing their life style.
Detailed Description
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Many studies report higher incidence of DM type 2 following Gestational Diabetes Mellitus (GDM). GDM is defined as glucose intolerance which is detected during pregnancy in healthy women. Its frequency varies between 1 to 14% in pregnant women in different populations. Although usually glucose intolerance disappears after delivery,many of these women may develop future GMD or DM type 2. This can be delayed or even prevented by appropriate diet and increased physical activity.
The aim of our study was:
1. To determine GDM frequency in Jewish and Bedouin populations in the Negev area in southern Israel.
2. To approach Jewish and Bedouin GDM women before discharge from the hospital and invite them to join the study and divide them into intervention group and control respectively.
3. To study whether intervention in life style leads to similar results in both populations.
4. To propose a model for predicting persistent lifestyle change intervention.
The study included 180 women diagnosed with GDM ,133 Jewish and 47 Bedouin women.The women were divided in two groups, an intervention group (77 Jewish and 26 Bedouin) and control ones (56 Jewish and 21 Bedouin women). At their first visit, 3 months after delivery all women filled forms about demographic data, nutrition and physical habits. All of them, including the control group were given full information about GDM and increased risk for DM.
All the women signed their informed consent forms for participation in the study. The intervention group had several group meetings every several months. Metabolic parameters were determined, including plasma insulin ,glucose and lipids levels.Height, weight, BMI, blood pressure and abdominal circumference were measured too. The same parameters were determined one and two years post partum. The intervention group had several group meetings every several months with a dietician and a physical exercise instructor.
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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Post GDM follow-up group.
Lifestyle instruction for Jews and Bedouin GDM women.
Every several months the women had instructions and checkups.
lifestyle intervention group.
The women in this group had participated in lifestyle intervention by diet instructions and physical exercise program.
Lifestyle instruction for Jews and Bedouin GDM women.
Every several months the women had instructions and checkups.
Interventions
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Lifestyle instruction for Jews and Bedouin GDM women.
Every several months the women had instructions and checkups.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
43 Years
FEMALE
Yes
Sponsors
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Soroka University Medical Center
OTHER
Responsible Party
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Naomi Meyerstein
Dr Naomi Meyerstein M D
Other Identifiers
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SOR452307CTL
Identifier Type: -
Identifier Source: org_study_id