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

University of Pennsylvania

Status: Completed

Conditions: Gestational Diabetes; Weight Gain During Pregnancy; Weight Loss After Pregnancy

Treatments: Behavioral: Intensive Behavioral Modification

Study type: Interventional

Funder types: Other

Identifiers

NCT01858233

IBEP

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Intensive Behavioral Modification

Experimental group

Description:

intensive dietary counseling, increased activity, lactation consult

Treatment:

Behavioral: Intensive Behavioral Modification

Routine care

No Intervention group

Description:

standard dietary counseling