Postpartum Weight Loss and Exercise (PRIDE)

Not Applicable

Completed

• Conditions: Gestational Diabetes; Glucose Intolerance

• Registration Number: NCT01296516
• Lead Sponsor: Pennington Biomedical Research Center

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:

1. decrease body weight and

2. reduce the rate of metabolic abnormalities, 12 months after delivery

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-14
• Study First Submitted QC: 2011-02-14
• Study First Posted: 2011-02-15
• Primary Completion: 2016-12
• Study Completion: 2017-12
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Incidence of glucose intolerance	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

Name	Time	Method
Weight loss	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

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States