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Postpartum Weight Loss and Exercise (PRIDE) (PRIDE)

Primary Purpose

Gestational Diabetes, Glucose Intolerance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Non-intervention group
Face to face
Telehelath Group
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gestational Diabetes focused on measuring Women, Postpartum, GDM

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Pennington Biomedical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Control Group

Face-to-face group

Telehealth Group

Arm Description

A group matched for age and BMI will be selected to serve as control subjects in this study.

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.

Participants randomized to the Telehealth intervention will receive behavioral counseling through Trestletree, phone system.

Outcomes

Primary Outcome Measures

Incidence of glucose intolerance
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
Weight loss through increased physical activity and dietary modification will achieve similar results when delivered via face-to-face contact (DPP) or via telehealth

Full Information

First Posted
February 14, 2011
Last Updated
August 23, 2021
Sponsor
Pennington Biomedical Research Center
Collaborators
THE C.B. AND IRENE PENNINGTON FOUNDATION
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1. Study Identification

Unique Protocol Identification Number
NCT01296516
Brief Title
Postpartum Weight Loss and Exercise (PRIDE)
Acronym
PRIDE
Official Title
Early Postpartum Treatment of Gestational Diabetes With Weight Loss and Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center
Collaborators
THE C.B. AND IRENE PENNINGTON FOUNDATION

4. Oversight

Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes, Glucose Intolerance
Keywords
Women, Postpartum, GDM

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
A group matched for age and BMI will be selected to serve as control subjects in this study.
Arm Title
Face-to-face group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Telehealth Group
Arm Type
Active Comparator
Arm Description
Participants randomized to the Telehealth intervention will receive behavioral counseling through Trestletree, phone system.
Intervention Type
Behavioral
Intervention Name(s)
Non-intervention group
Other Intervention Name(s)
Placebo
Intervention Description
A pedometer and written material on a healthy lifestyle.
Intervention Type
Behavioral
Intervention Name(s)
Face to face
Intervention Description
Motivational meetings held once per week; Behavioral sessions weill be led by a trained interventionist.
Intervention Type
Behavioral
Intervention Name(s)
Telehelath Group
Other Intervention Name(s)
Trestletree
Intervention Description
Participants will speak to Trestletree personnel once a week via phone.
Primary Outcome Measure Information:
Title
Incidence of glucose intolerance
Description
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.
Time Frame
8 Months
Secondary Outcome Measure Information:
Title
Weight loss
Description
Weight loss through increased physical activity and dietary modification will achieve similar results when delivered via face-to-face contact (DPP) or via telehealth
Time Frame
8 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leanne M. Redman, PhD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karen Elkind-Hirsh, PhD
Organizational Affiliation
Womans' Research Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Catherine Chamagne, PhD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Timothy S. Church, MD, MPH, PhD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Eric Ravussin, PhD
Organizational Affiliation
Pennington Biomedical Reserach Center
Official's Role
Study Chair
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States

12. IPD Sharing Statement

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Postpartum Weight Loss and Exercise (PRIDE)

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