NCT01489163CompletedNot Applicable
Translational Diabetes Prevention in GDM
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Kaiser Permanente
- Enrollment
- 352
- Locations
- 2
- Primary Endpoint
- postpartum body weight
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Control
No Intervention
Lifestyle Counseling
Experimental
Intervention: Lifestyle Counseling (Behavioral)
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)
Investigators
Study Sites (2)
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