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Postpartum Weight Loss and Exercise (PRIDE) (PRIDE)

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ClinicalTrials.gov Identifier: NCT01296516
Recruitment Status : Active, not recruiting
First Posted : February 15, 2011
Last Update Posted : November 21, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Gestational Diabetes Glucose Intolerance Behavioral: Non-intervention group Behavioral: Face to face Behavioral: Telehelath Group

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Study Start Date : February 2011
Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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
Sponsors and Collaborators
Pennington Biomedical Research Center
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

Responsible Party: Leanne Redman, Principle Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01296516     History of Changes
Other Study ID Numbers: PBRC 10041
First Posted: February 15, 2011    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: November 2017

Keywords provided by Leanne Redman, Pennington Biomedical Research Center:

Additional relevant MeSH terms:
Weight Loss
Diabetes, Gestational
Glucose Intolerance
Body Weight Changes
Body Weight
Signs and Symptoms
Pregnancy Complications
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases