The IBEP Study: an Intervention for Lifestyle Modification in Women With Gestational Diabetes

Not Applicable

Completed

• Conditions: Gestational Diabetes; Weight Loss After Pregnancy; Weight Gain During Pregnancy
• Interventions: Behavioral: Intensive Behavioral Modification

• Registration Number: NCT01858233
• Lead Sponsor: University of Pennsylvania

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-05-08
• Study First Submitted QC: 2013-05-16
• Study First Posted: 2013-05-21
• Primary Completion: 2015-09
• Status Verified: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-03
• Last Update Posted: 2015-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 110

Inclusion Criteria

• women diagnosed with gestational diabetes between 20 and 34 weeks gestation

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Exclusion Criteria

• women on chronic steroid therapy
• women with a diagnosis of GDM <20 weeks or >34 weeks

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intensive Behavioral Modification	Intensive Behavioral Modification	intensive dietary counseling, increased activity, lactation consult

Primary Outcome Measures

Name	Time	Method
The IBEP Study	2 years	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.

Secondary Outcome Measures

Name	Time	Method
The IBEP Study	2 years	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.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States