Postpartum Weight Loss and Exercise (PRIDE)

Sponsor

Pennington Biomedical Research Center (Other)

Overall Status

Completed

CT.gov ID

NCT01296516

Collaborator

THE C.B. AND IRENE PENNINGTON FOUNDATION (Other)

Enrollment

Location

Arms

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

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	Phase
Gestational Diabetes Glucose Intolerance	Behavioral: Non-intervention group Behavioral: Face to face Behavioral: Telehelath Group	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

7 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 :

Feb 1, 2011

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2017

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 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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pennington Biomedical Research Center	Baton Rouge	Louisiana	United States	70808

Sponsors and Collaborators

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

Investigators

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