Postpartum Weight Loss and Exercise (PRIDE)
Completed · Not applicable · Has a placebo group
Conditions studied: Gestational Diabetes, Glucose Intolerance
In brief
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.
Key facts
- Study ID
- NCT01296516
- Run by
- Pennington Biomedical Research Center
- People needed
- 7
- Starts
- 2011-02-01
- Expected to finish
- 2017-12-01
- Last updated by the study team
- 2021-08-24
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States
Full record on ClinicalTrials.gov
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