Postpartum Weight Loss and Exercise (PRIDE)

Gestational Diabetes Clinical Trial

— PRIDE  

Official title:

Early Postpartum Treatment of Gestational Diabetes With Weight Loss and Exercise

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01296516
• Other study ID #: PBRC 10041
• Status: Completed
• Phase: N/A
• Start date: February 2011
• Est. completion date: December 2017

Study information

• Verified date: August 2021
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes
• Glucose Intolerance
• Weight Loss

Intervention

Behavioral:
• Non-intervention group
A pedometer and written material on a healthy lifestyle.
• Face to face
Motivational meetings held once per week; Behavioral sessions weill be led by a trained interventionist.
• Telehelath Group
Participants will speak to Trestletree personnel once a week via phone.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	THE C.B. AND IRENE PENNINGTON FOUNDATION

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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