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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01858233
First received: May 8, 2013
Last updated: May 16, 2013
Last verified: May 2013
  Purpose

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 Intervention
Gestational Diabetes
Weight Gain During Pregnancy
Weight Loss After Pregnancy
Behavioral: Intensive Behavioral Modification

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • The IBEP Study [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 120
Study Start Date: November 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01858233

Contacts
Contact: Celeste P Durnwald, MD 215-662-6913 celeste.durnwald@uphs.upenn.edu

Locations
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Celeste P Durnwald, MD         
Sub-Investigator: Kelly Allison, PhD         
Sponsors and Collaborators
University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01858233     History of Changes
Other Study ID Numbers: IBEP
Study First Received: May 8, 2013
Last Updated: May 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Gestational diabetes

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

ClinicalTrials.gov processed this record on October 21, 2014