Postpartum Weight Loss and Exercise (PRIDE) (PRIDE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01296516|
Recruitment Status : Completed
First Posted : February 15, 2011
Last Update Posted : February 15, 2018
|Condition or disease||Intervention/treatment|
|Gestational Diabetes Glucose Intolerance||Behavioral: Non-intervention group Behavioral: Face to face Behavioral: Telehelath Group|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Factorial Assignment|
|Official Title:||Early Postpartum Treatment of Gestational Diabetes With Weight Loss and Exercise|
|Study Start Date :||February 2011|
|Primary Completion Date :||December 2016|
|Study Completion Date :||December 2017|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|