- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00164489
Health Promotion of People With Disabilities
Intervention Research Grants to Promote the Health of People With Disabilities
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Park Nicollet Clinic and the Institute for Clinical Systems Integration (ICSI) have developed evidence-based care guidelines and intervention strategies including degenerative joint disease. Included in these guidelines are risk factors for increased limitations, obesity and physical activity.
The aims of this research are to modify well-established weight management techniques and physical activity promotion interventions according to ICSI recommendations, implement the interventions in a diverse patient population, demonstrate the short and long term impact of the interventions.
The approach will be an individual randomized controlled trial of 400 patients, 200 each in a coach-supported intervention, 200 in a self-directed intervention.
Study Type
Enrollment
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Minnesota
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Minneapolis, Minnesota, United States, 55416
- Park Nicollet Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- clinical visit 11/1/2003 to april 30/2004 diagnosis code rheumatoid arthritis or lower extremity osteoarthritis saw a provider that consented to have patients invited to participate consented to being contacted for research
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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height weight: BMI
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Healthy physical activity levels: 20 minutes of physical activity 4+ days/week
|
Secondary Outcome Measures
Outcome Measure |
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improved weight status
|
improved diet
|
decreased pain
|
reduced depression
|
Collaborators and Investigators
Investigators
- Principal Investigator: Barbara Braun, Ph.D., HealthPartners Institute
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDC-NCBDDD-CCR523273
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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