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

Gestational Diabetes Clinical Trial

— IBEP  

Official title:

The IBEP Study: a Randomized Control Trial of an Educational Intervention for Lifestyle Modification in Women With Gestational Diabetes.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01858233
• Other study ID #: IBEP
• 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

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes
• Weight Gain
• Weight Gain During Pregnancy
• Weight Loss
• Weight Loss After Pregnancy

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