Translational Diabetes Prevention in GDM

Kaiser Permanente1 site in 1 country352 target enrollmentDecember 2011

ConditionsGestational Diabetes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Gestational Diabetes
Sponsor: Kaiser Permanente
Enrollment: 352
Locations: 1
Primary Endpoint: postpartum body weight
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this research study is to implement and evaluate a lifestyle program designed to help women who have high glucose levels during pregnancy make healthful diet and physical activity changes to lose weight. Eligible women will be randomly assigned to life-style intervention or usual medical care.

Registry

clinicaltrials.gov

Start Date

December 2011

End Date

December 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Kaiser Permanente

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Women receiving prenatal care at Kaiser Permanente Santa Clara, Santa Teresa, Hayward, and Oakland
•Pregnancy complicated by high glucose levels starting November 2011

Exclusion Criteria

•Recognized DM prior to pregnancy
•Uncontrolled hypertension during pregnancy
•Severe active thyroid disease during pregnancy
•Severe diseases of the cardio-pulmonary system
•Diagnosis of a severe psychiatric disorder
•Diagnosis of cancer
•Conditions that lead to diet changes
•Addiction to alcohol or illegal drugs
•Current corticosteroid medicine use

Outcomes

Primary Outcomes

postpartum body weight

Time Frame: through 24 months postpartum

Secondary Outcomes

time spent in physical activity (PA) by intensity(through 24 months postpartum)
percent of calories from fat(through 24 months postpartum)
the proportion of women who reach body weight goals(through 24 months postpartum)
postpartum glycemia(through 24 months postpartum)