Postpartum Weight Loss and Exercise (PRIDE) (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.

Study Overview

• Status: Completed
• Conditions: Glucose Intolerance; Gestational Diabetes
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: Trestletree

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	8 months

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Collaborators: THE C.B. AND IRENE PENNINGTON FOUNDATION
• Investigators: Study Chair: Timothy S. Church, MD, MPH, PhD, 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: Eric Ravussin, PhD, Pennington Biomedical Reserach Center

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: February 14, 2011
• First Submitted That Met QC Criteria: February 14, 2011
• First Posted (Estimate): February 15, 2011

Study Record Updates

• Last Update Posted (Actual): August 24, 2021
• Last Update Submitted That Met QC Criteria: August 23, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Women; Postpartum; GDM
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Body Weight; Pregnancy Complications; Body Weight Changes; Hyperglycemia; Weight Loss; Glucose Intolerance; Diabetes, Gestational
• Other Study ID Numbers: PBRC 10041