Postpartum Weight Loss and Exercise (PRIDE)

Not Applicable

Completed

• Conditions: Gestational Diabetes; Glucose Intolerance
• Interventions: Behavioral: Face to face; Behavioral: Telehelath Group; Behavioral: Non-intervention group

• 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

Arm && Interventions

Group	Intervention	Description
Face-to-face group	Face to face	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.
Telehealth Group	Telehelath Group	Participants randomized to the Telehealth intervention will receive behavioral counseling through Trestletree, phone system.
Control Group	Non-intervention group	A group matched for age and BMI will be selected to serve as control subjects in this study.

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