The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) supports a range of clinical trials studying new and existing interventions for prevention and treatment of arthritis, musculoskeletal, and skin diseases. Recruitment for this clinical trial complete. Updates will be made to this page when the study completes data analysis and results become available. Please check back often and find out how these studies have contributed to generating new knowledge about diseases and conditions within the NIAMS mission area.
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Study Description
Obesity is a modifiable risk factor for knee osteoarthritis (OA), and weight loss is an effective non-pharmacologic treatment to reduce pain. Recently, the investigators determined that under ideal, highly controlled circumstances, a diet-induced weight loss of 10% combined with exercise was significantly better at reducing pain than either intervention alone. Compared to the investigators previous long term weight loss and exercise trials of knee OA, the diet-induced weight loss and exercise group was twice as effective at relieving pain. Whether the investigators results can be generalized to less rigorously monitored patient cohorts is unknown. Thus the challenge the investigators now face is to provide the practical means to implement this proven treatment in the community setting. This study aims to develop and demonstrate the effectiveness of a systematic, practical, cost-effective diet-induced weight loss and exercise intervention in both urban and rural communities that can reduce pain and improve other clinical outcomes in knee OA patients. This pragmatic community-based trial will determine if the investigators previous findings translate to real-world settings and will address common concerns about barriers to effectiveness/ implementation.
ELIGIBILITY CRITERIA:
Inclusion Criteria:
Ambulatory, community-dwelling, overweight and obese (BMI ≥ 27 kg/m2) men and women greater than or equal to 50 years who meet the American College of Rheumatology clinical criteria for knee OA with self-reported disability due to knee OA.
Exclusion Criteria:
- Significant co-morbid disease that would threaten safety or impair ability to participate in interventions or testing (Blindness; Type 1 diabetes; Severe coronary artery disease)
- Not sufficiently overweight or obese, BMI < 27 kg/m2
- Not having knee pain
- Inability to finish 18-month study or unlikely to be compliant (Planning to leave area > 2 month during the next 18 months; Unwilling to change eating or physical activity habits; Unwilling to discontinue pain medication use for 3 days prior to testing visit)
- Age, age < 50
- Other conditions that may prohibit the effective delivery of the intervention (Unable to provide own transportation to exercise center; Unable to read or write.
Study Design:
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcome Assessor)
Primary Purpose: Treatment
Study Location:
United States, North Carolina
Study Website:
https://clinicaltrials.gov/ct2/show/NCT02577549?term=Messier+Knee+OA&rank=1