Gestational Diabetes Clinical Trial
— IBEPOfficial title:
The IBEP Study: a Randomized Control Trial of an Educational Intervention for Lifestyle Modification in Women With Gestational Diabetes.
Verified date | December 2015 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The IBEP study is a randomized control trial of a healthy lifestyle intervention program for women with gestational diabetes. The primary aim of the study is to evaluate whether women with gestational diabetes enrolled in an intensive behavioral educational program (IBEP) demonstrate lower mean fasting glucose levels measured by 2 hour 75 gram oral glucose tolerance test (OGTT) at 6 weeks postpartum compared to women with gestational diabetes who undergo routine gestational diabetes education and counseling.
Status | Completed |
Enrollment | 110 |
Est. completion date | December 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - women diagnosed with gestational diabetes between 20 and 34 weeks gestation Exclusion Criteria: - women on chronic steroid therapy - women with a diagnosis of GDM <20 weeks or >34 weeks |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The IBEP Study | To evaluate mean fasting glucose levels measured by 2 hour 75 gram oral glucose tolerance test (OGTT) at 6 weeks in women enrolled in an intensive behavioral educational program compared to women with GDM who undergo routine GDM education and counseling. | 2 years | No |
Secondary | The IBEP Study | To evaluate the amount of weight lost in women enrolled in an intensive behavioral program and whether it correlates with more favorable lipid profiles at 6 weeks postpartum. | 2 years | No |
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