We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01858233
Recruitment Status : Completed
First Posted : May 21, 2013
Last Update Posted : December 4, 2015
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Gestational Diabetes Weight Gain During Pregnancy Weight Loss After Pregnancy Behavioral: Intensive Behavioral Modification

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The IBEP Study: a Randomized Control Trial of an Educational Intervention for Lifestyle Modification in Women With Gestational Diabetes.
Study Start Date : November 2012
Primary Completion Date : September 2015
Study Completion Date : December 2015
Arms and Interventions

Arm Intervention/treatment
Experimental: Intensive Behavioral Modification
intensive dietary counseling, increased activity, lactation consult
Behavioral: Intensive Behavioral Modification
Intensive dietary counseling, increased physical activity, lactation counseling
No Intervention: Routine care
standard dietary counseling


Outcome Measures

Primary Outcome Measures :
  1. The IBEP Study [ Time Frame: 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 :
  1. The IBEP Study [ Time Frame: 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.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01858233


Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Celeste Durnwald, MD University of Pennsylvania
More Information

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01858233     History of Changes
Other Study ID Numbers: IBEP
First Posted: May 21, 2013    Key Record Dates
Last Update Posted: December 4, 2015
Last Verified: December 2015

Keywords provided by University of Pennsylvania:
Gestational diabetes

Additional relevant MeSH terms:
Diabetes, Gestational
Diabetes Mellitus
Body Weight
Weight Loss
Weight Gain
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Signs and Symptoms
Body Weight Changes
Pregnancy Complications