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

NCT ID: NCT01858233

Last Updated: 2015-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gestational Diabetes Weight Gain During Pregnancy Weight Loss After Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intensive Behavioral Modification

intensive dietary counseling, increased activity, lactation consult

Group Type EXPERIMENTAL

Intensive Behavioral Modification

Intervention Type BEHAVIORAL

Intensive dietary counseling, increased physical activity, lactation counseling

Routine care

standard dietary counseling

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intensive Behavioral Modification

Intensive dietary counseling, increased physical activity, lactation counseling

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Celeste Durnwald, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 27398697 (View on PubMed)

Other Identifiers

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IBEP

Identifier Type: -

Identifier Source: org_study_id