The IBEP Study: an Intervention for Lifestyle Modification in Women With Gestational Diabetes
IBEP
The IBEP Study: a Randomized Control Trial of an Educational Intervention for Lifestyle Modification in Women With Gestational Diabetes.
1 other identifier
interventional
110
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 8, 2013
CompletedFirst Posted
Study publicly available on registry
May 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedDecember 4, 2015
December 1, 2015
2.8 years
May 8, 2013
December 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
The IBEP Study
2 years
Study Arms (2)
Intensive Behavioral Modification
EXPERIMENTALintensive dietary counseling, increased activity, lactation consult
Routine care
NO INTERVENTIONstandard dietary counseling
Interventions
Intensive dietary counseling, increased physical activity, lactation counseling
Eligibility Criteria
You may qualify if:
- women diagnosed with gestational diabetes between 20 and 34 weeks gestation
You may not qualify if:
- women on chronic steroid therapy
- women with a diagnosis of GDM \<20 weeks or \>34 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Related Publications (1)
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.
PMID: 27398697DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Celeste Durnwald, MD
University of Pennsylvania
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2013
First Posted
May 21, 2013
Study Start
November 1, 2012
Primary Completion
September 1, 2015
Study Completion
December 1, 2015
Last Updated
December 4, 2015
Record last verified: 2015-12