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Completed

NCT Number: NCT01296516

Postpartum Weight Loss and Exercise (PRIDE)

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.

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-intervention group

Behavioral

A pedometer and written material on a healthy lifestyle.

Other names: Placebo

Face to Face

Behavioral

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

Telehelath Group

Behavioral

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

Other names: Trestletree

Primary outcomes

  1. Incidence of glucose intolerance

    Time frame: 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 outcomes

  1. Weight loss

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • THE C.B. AND IRENE PENNINGTON FOUNDATION

Registry information

Official study title

Early Postpartum Treatment of Gestational Diabetes With Weight Loss and Exercise

Acronym: PRIDE

Important dates

Study start
2011
Primary completion
2016
Study completion
2017
First posted
Feb 15, 2011
Registry last updated
Aug 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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