Health Promotion of People With Disabilities
Primary Purpose
Rheumatoid and Osteoarthritis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Weight control and physical activity promotion
Sponsored by
About this trial
This is an interventional prevention trial for Rheumatoid and Osteoarthritis
Eligibility Criteria
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: -
Sites / Locations
- Park Nicollet Institute
Outcomes
Primary Outcome Measures
height weight: BMI
Healthy physical activity levels: 20 minutes of physical activity 4+ days/week
Secondary Outcome Measures
improved weight status
improved diet
decreased pain
reduced depression
Full Information
NCT ID
NCT00164489
First Posted
September 12, 2005
Last Updated
September 12, 2005
Sponsor
Centers for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT00164489
Brief Title
Health Promotion of People With Disabilities
Official Title
Intervention Research Grants to Promote the Health of People With Disabilities
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Centers for Disease Control and Prevention
4. Oversight
5. Study Description
Brief Summary
This research is meant to evaluate the effectiveness of two different prevention programs for post-acute management of rheumatoid and osteo-arthritis
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid and Osteoarthritis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Weight control and physical activity promotion
Primary Outcome Measure Information:
Title
height weight: BMI
Title
Healthy physical activity levels: 20 minutes of physical activity 4+ days/week
Secondary Outcome Measure Information:
Title
improved weight status
Title
improved diet
Title
decreased pain
Title
reduced depression
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Braun, Ph.D.
Organizational Affiliation
HealthPartners Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Park Nicollet Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Health Promotion of People With Disabilities
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