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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01858233
Other study ID # IBEP
Secondary ID
Status Completed
Phase N/A
First received May 8, 2013
Last updated December 3, 2015
Start date November 2012
Est. completion date December 2015

Study information

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

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Behavioral:
Intensive Behavioral Modification
Intensive dietary counseling, increased physical activity, lactation counseling

Locations

Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

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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