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Completed

NCT Number: NCT01858233

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

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.

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Key information

Conditions

Gestational Diabetes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases Weight Gain During Pregnancy Weight Loss After Pregnancy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intensive Behavioral Modification

Behavioral

Intensive dietary counseling, increased physical activity, lactation counseling

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

The IBEP Study: a Randomized Control Trial of an Educational Intervention for Lifestyle Modification in Women With Gestational Diabetes.

Acronym: IBEP

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
May 21, 2013
Registry last updated
Dec 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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