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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intensive Behavioral Modification
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gestational Diabetes focused on measuring Gestational diabetes

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intensive Behavioral Modification

Routine care

Arm Description

intensive dietary counseling, increased activity, lactation consult

standard dietary counseling

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 8, 2013
Last Updated
December 3, 2015
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT01858233
Brief Title
The IBEP Study: an Intervention for Lifestyle Modification in Women With Gestational Diabetes
Acronym
IBEP
Official Title
The IBEP Study: a Randomized Control Trial of an Educational Intervention for Lifestyle Modification in Women With Gestational Diabetes.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes, Weight Gain During Pregnancy, Weight Loss After Pregnancy
Keywords
Gestational diabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intensive Behavioral Modification
Arm Type
Experimental
Arm Description
intensive dietary counseling, increased activity, lactation consult
Arm Title
Routine care
Arm Type
No Intervention
Arm Description
standard dietary counseling
Intervention Type
Behavioral
Intervention Name(s)
Intensive Behavioral Modification
Intervention Description
Intensive dietary counseling, increased physical activity, lactation counseling
Primary Outcome Measure Information:
Title
The IBEP Study
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
The IBEP Study
Description
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.
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Celeste Durnwald, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27398697
Citation
Durnwald CP, Kallan MJ, Allison KC, Sammel MD, Wisch S, Elovitz M, Parry S. A Randomized Clinical Trial of an Intensive Behavior Education Program in Gestational Diabetes Mellitus Women Designed to Improve Glucose Levels on the 2-Hour Oral Glucose Tolerance Test. Am J Perinatol. 2016 Oct;33(12):1145-51. doi: 10.1055/s-0036-1585085. Epub 2016 Jul 11.
Results Reference
derived

Learn more about this trial

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

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