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

February 14, 2011
November 27, 2013
February 2011
August 2014   (final data collection date for primary outcome measure)
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.
  • Reduce the incidence of glucose intolerance in women with a history of GDM, 12 months postpartum [ 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.
  • Decrease body weight [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Women with Gestational diabetes mellitus (GDM) measuring for decreased body weight during early postpartum.
Complete list of historical versions of study NCT01296516 on ClinicalTrials.gov Archive Site
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
Weight loss through increased physical activity and dietary modification will achieve greater results [ 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
Not Provided
Not Provided
 
Postpartum Weight Loss and Exercise (PRIDE)
Early Postpartum Treatment of Gestational Diabetes With Weight Loss and Exercise

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.

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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
  • Gestational Diabetes
  • Glucose Intolerance
  • Behavioral: Non-intervention group
    A pedometer and written material on a healthy lifestyle.
    Other Name: Placebo
  • Behavioral: Face to face
    Motivational meetings held once per week; Behavioral sessions weill be led by a trained interventionist.
    Other Name: Face to face
  • Behavioral: Telehelath Group
    Participants will speak to Trestletree personnel once a week via phone.
    Other Name: Trestletree
  • Placebo Comparator: Control Group
    A group matched for age and BMI will be selected to serve as control subjects in this study.
    Intervention: Behavioral: Non-intervention group
  • 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.
    Intervention: Behavioral: Face to face
  • Active Comparator: Telehealth Group
    Participants randomized to the Telehealth intervention will receive behavioral counseling through Trestletree, phone system.
    Intervention: Behavioral: Telehelath Group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
50
August 2014
August 2014   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01296516
PBRC10041 PRIDE
No
Leanne Redman, Pennington Biomedical Research Center
Pennington Biomedical Research Center
THE C.B. AND IRENE PENNINGTON FOUNDATION
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
Pennington Biomedical Research Center
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP