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Exercise and Dietary Weight Loss for Osteoarthritis (CLIP-OA Trial)
N/A
Waitlist Available
Led By Brian Focht, PhD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 2 years
Awards & highlights
CLIP-OA Trial Summary
This trial is testing whether a community-based diet and exercise program can help improve mobility in people with knee osteoarthritis better than the current standard program.
Eligible Conditions
- Osteoarthritis
CLIP-OA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mobility Disability
Secondary outcome measures
Anthropometric Battery
Change in physical activity
Cost effectiveness
+5 moreCLIP-OA Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Exercise and Dietary Weight LossExperimental Treatment1 Intervention
For the first 6 months, participants will meet at a community center for 3 group-based sessions and 1 individual session each month. Sessions include a 45 minute exercise component and a 45 minute dietary weight loss component. Exercise will consist of progressive aerobic and strength training. The dietary component will focus on decreasing caloric intake, while being nutritionally safe. All diets will be monitored by a Registered Dietitian. During months 7-12, participants will meet for 1 group session and 1 individual session per month. The final 12-24 months, bimonthly phone calls are provided to the participants to aid in retention efforts.
Group II: Walk with EaseActive Control1 Intervention
The Arthritis Foundation's (AF) WWE is a self-management program for symptoms of arthritis (pain, fatigue, stiffness,etc.) through exercise. It is a 6 week program involving 3 sessions per week each lasting about 60 minutes. The WWE sessions are comprised of walking, stretching and strengthening exercises, and health education lectures. These group classes will be lead by an AF instructor. Each participant will complete 2 consecutive WWE classes for a total of 12 weeks in the program. During the final week of the program, participants will be trained and transitioin to the self-directed version of WWE for maintenance of exercise. To aid in retention efforts, phone contacts are provided to participants on a monthly basis from 4-12 months and bi-monthly from 12 to 24 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise and Dietary Weight Loss
2016
N/A
~230
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Who is running the clinical trial?
Ohio State UniversityLead Sponsor
829 Previous Clinical Trials
505,516 Total Patients Enrolled
5 Trials studying Osteoarthritis
669 Patients Enrolled for Osteoarthritis
National Institutes of Health (NIH)NIH
2,698 Previous Clinical Trials
7,492,272 Total Patients Enrolled
20 Trials studying Osteoarthritis
4,641 Patients Enrolled for Osteoarthritis
National Institute on Aging (NIA)NIH
1,672 Previous Clinical Trials
28,018,436 Total Patients Enrolled
29 Trials studying Osteoarthritis
9,831 Patients Enrolled for Osteoarthritis
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