This trial is active, not recruiting.

Condition gestational diabetes
Treatment lifestyle counseling
Sponsor Kaiser Permanente
Start date December 2011
End date October 2015
Trial size 350 participants
Trial identifier NCT01489163, CN-03AFerr-02-H


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose prevention
lifestyle counseling
The Phase I intervention will be delivered through 1 individual in-person session and 3 individual telephone counseling contacts. The Phase II intervention begins at 6-week postpartum and will be delivered through 3 individual in-person sessions and 13 telephone counseling contacts over a period of 6 months. The maintenance phase (Phase III) will begin at 8 months postpartum.
(No Intervention)

Primary Outcomes

postpartum body weight
time frame: through 24 months postpartum

Secondary Outcomes

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

Eligibility Criteria

Female participants from 20 years up to 45 years old.

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

Additional Information

Official title Translational Diabetes Prevention in GDM
Principal investigator Assiamira Ferrara, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Kaiser Permanente.