Postpartum Weight Loss and Exercise (PRIDE)

NCT01296516 | Completed

• 1 other identifier: PBRC 10041
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes; Glucose Intolerance

Keywords

Women; Postpartum; GDM

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Weight loss

  8 months

Study Arms (3)

Control Group

PLACEBO COMPARATOR

A group matched for age and BMI will be selected to serve as control subjects in this study.

Behavioral: Non-intervention group

Face-to-face group

ACTIVE COMPARATOR

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

Telehealth Group

ACTIVE COMPARATOR

Participants randomized to the Telehealth intervention will receive behavioral counseling through Trestletree, phone system.

Behavioral: Telehelath Group

Interventions

Non-intervention group BEHAVIORAL

A pedometer and written material on a healthy lifestyle.

Also known as: Placebo

Control Group

Face to face BEHAVIORAL

Motivational meetings held once per week; Behavioral sessions weill be led by a trained interventionist.

Face-to-face group

Telehelath Group BEHAVIORAL

Participants will speak to Trestletree personnel once a week via phone.

Also known as: Trestletree

Telehealth Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Postpartum Women ≥18 years to 45 years (inclusive) of age who experienced GDM during index pregnancy
• English-speaking

You may not qualify if:

• Women enrolled in COPSS-GDM will be excluded if they met the following 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
• History or clinical manifestation of any eating disorder
• Smoking
• Pregnancy or pregnancy planned during the coming year
• Unwilling or unable to adhere to the clinical evaluation schedule over the twelve -month study period

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• THE C.B. AND IRENE PENNINGTON FOUNDATION: collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational; Glucose Intolerance

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia

Study Officials

• Leanne M. Redman, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

• Karen Elkind-Hirsh, PhD

  Womans' Research Hospital

  STUDY DIRECTOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: February 14, 2011
• First Posted: February 15, 2011
• Study Start: February 1, 2011
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: August 24, 2021

Record last verified: 2021-08

Locations

US (1)