Postpartum Weight Loss and Exercise (PRIDE)
This study is enrolling participants by invitation only.
Sponsor:
Pennington Biomedical Research Center
Collaborator:
THE C.B. AND IRENE PENNINGTON FOUNDATION
Information provided by (Responsible Party):
Leanne Redman, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01296516
First received: February 14, 2011
Last updated: December 7, 2012
Last verified: December 2012
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Purpose
The overall objective of this pilot project is to test in 50 women with a history of gestational diabetes mellitus (GDM), the effectiveness and feasibility of an 8 month intensive lifestyle intervention to reduce the rate of metabolic abnormalities within 1 year after delivery.
| Condition | Intervention |
|---|---|
|
Gestational Diabetes Glucose Intolerance |
Behavioral: Non-intervention group Behavioral: Face to face Behavioral: Telehelath Group |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention |
| Official Title: | Early Postpartum Treatment of Gestational Diabetes With Weight Loss and Exercise |
Resource links provided by NLM:
Further study details as provided by Pennington Biomedical Research Center:
Primary Outcome Measures:
- Incidence of glucose intolerance [ Time Frame: 8 Months ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Weight loss [ Time Frame: 8 months ] [ Designated as safety issue: No ]Weight loss through increased physical activity and dietary modification will achieve similar results when delivered via face-to-face contact (DPP) or via telehealth
| Enrollment: | 50 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
Other Name: Face to face
|
|
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
|
Detailed Description:
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
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Women are required to be enrolled (provided written consent for participation) in the COPSS-GDM study and therefore have met the following inclusion criteria:
- Postpartum Women ≥18 years to 45 years (inclusive) of age who experienced GDM during index pregnancy
- English-speaking
Exclusion Criteria:
Exclusion Criteria:
- Women enrolled in COPSS-GDM will be excluded if they met the following criteria:
Medical Exclusion Criteria
- History or clinical manifestation of any other significant metabolic, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, immune, hepatic, renal, urologic disorders, or cancer
- Regular use of medications for weight control or psychosis
- Current use of medication to treat diabetes Psychiatric and Behavioral Exclusion Criteria
- History or clinical manifestation of any eating disorder
- Smoking
- History of drug or alcohol abuse (up to 14 drinks a week are allowed) within the past two years Other Exclusion Criteria
- Pregnancy or pregnancy planned during the coming year
- Unwilling or unable to adhere to the clinical evaluation schedule over the twelve -month study period
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01296516
Locations
| United States, Louisiana | |
| Pennington Biomedical Research Center | |
| Baton Rouge, Louisiana, United States, 70808 | |
Sponsors and Collaborators
Pennington Biomedical Research Center
THE C.B. AND IRENE PENNINGTON FOUNDATION
Investigators
| 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 |
More Information
No publications provided
| Responsible Party: | Leanne Redman, Principle Investigator, Pennington Biomedical Research Center |
| ClinicalTrials.gov Identifier: | NCT01296516 History of Changes |
| Other Study ID Numbers: | PBRC10041 PRIDE |
| Study First Received: | February 14, 2011 |
| Last Updated: | December 7, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Pennington Biomedical Research Center:
|
Women Postpartum GDM |
Additional relevant MeSH terms:
|
Diabetes Mellitus Weight Loss Diabetes, Gestational Glucose Intolerance Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Body Weight Changes Body Weight Signs and Symptoms Pregnancy Complications Hyperglycemia |
ClinicalTrials.gov processed this record on May 16, 2013