Postpartum Weight Loss and Exercise (PRIDE) (PRIDE)
|Gestational Diabetes Glucose Intolerance||Behavioral: Non-intervention group Behavioral: Face to face Behavioral: Telehelath Group|
|Study Design:||Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
|Official Title:||Early Postpartum Treatment of Gestational Diabetes With Weight Loss and Exercise|
- Incidence of glucose intolerance [ Time Frame: 8 Months ]To examine the incidence of glucose abnormalities (impaired fasting glucose, impaired glucose tolerance, type 2 diabetes) and health outcomes (changes in body fat, waist circumference and blood lipids)in women with a history of gestational diabetes, 12 months postpartum.
- Weight loss [ Time Frame: 8 months ]Weight loss through increased physical activity and dietary modification will achieve similar results when delivered via face-to-face contact (DPP) or via telehealth
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||December 2017|
|Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Placebo Comparator: Control Group
A group matched for age and BMI will be selected to serve as control subjects in this study.
Behavioral: Non-intervention group
A pedometer and written material on a healthy lifestyle.
Other Name: Placebo
Active Comparator: Face-to-face group
Participants randomized to the face-to-face intervention will attend motivational meetings held once per week in Phase I and biweekly in Phase II. Behavioral sessions will be led by a trained interventionist and will take place at Pennington Biomedical Research Center.
Behavioral: Face to face
Motivational meetings held once per week; Behavioral sessions weill be led by a trained interventionist.
Active Comparator: Telehealth Group
Participants randomized to the Telehealth intervention will receive behavioral counseling through Trestletree, phone system.
Behavioral: Telehelath Group
Participants will speak to Trestletree personnel once a week via phone.
Other Name: Trestletree
The objective is in comparison to a group of women not enrolled in the lifestyle intervention, 8 months of intensive lifestyle intervention aimed at promoting 7% weight loss through increased physical activity and dietary modification in women with a history of GDM will:
- decrease body weight and
- reduce the rate of metabolic abnormalities, 12 months after delivery
Please refer to this study by its ClinicalTrials.gov identifier: NCT01296516
|United States, Louisiana|
|Pennington Biomedical Research Center|
|Baton Rouge, Louisiana, United States, 70808|
|Principal Investigator:||Leanne M. Redman, PhD||Pennington Biomedical Research Center|
|Study Director:||Karen Elkind-Hirsh, PhD||Womans' Research Hospital|
|Study Chair:||Catherine Chamagne, PhD||Pennington Biomedical Research Center|
|Study Chair:||Timothy S. Church, MD, MPH, PhD||Pennington Biomedical Research Center|
|Study Chair:||Eric Ravussin, PhD||Pennington Biomedical Reserach Center|