Postpartum Weight Loss and Exercise (PRIDE)

This study is enrolling participants by invitation only.
Sponsor:
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: November 27, 2013
Last verified: November 2013
  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 2014
Estimated Primary Completion Date: August 2014 (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:

  1. decrease body weight and
  2. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: November 27, 2013
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 August 27, 2014