The Osteoarthritis Prevention Study
Recruiting now · Not applicable
Conditions studied: Osteoarthritis, Knee
In brief
The goal of this study is to establish the efficacy of an intervention of dietary weight loss, exercise, and weight-loss maintenance for knee Osteoarthritis (OA) prevention in adult females aged ≥ 50 years with obesity and no or infrequent knee pain. The primary aim is to compare the effects of a dietary weight loss, exercise, and weight-loss maintenance to an attention control group in preventing the development of structural Magnetic Resonance Imaging (MRI) knee OA. Secondary aims will determine the intervention effects on pain, mobility, health-related quality of life, knee joint compressive forces, inflammatory measures, weight loss, exercise self-efficacy, and cost-effectiveness of this intervention.
Key facts
- Study ID
- NCT05946044
- Run by
- Wake Forest University
- People needed
- 1230
- Starts
- 2024-03-21
- Expected to finish
- 2029-07-31
- Last updated by the study team
- 2026-07-23
Who can join
Age: 50 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Female
- BMI ≥ 30 kg/m2
- An eligible knee will have no OA by xray and MRI
- No or infrequent knee pain (< 15 days/month) in the same knee
You may not qualify if…
- symptomatic or severe coronary artery disease
- unable to walk without a device
- blindness
- type 1 diabetes
- active treatment for cancer
- during the past 12 months knee fracture, anterior cruciate ligament (ACL), medial collateral ligament (MCL), or meniscus injury with or without surgical repair
- knee injection during the past 6 months
- bilateral knee OA by x-ray Kellgren-Lawrence (KL) ≥ 2
- bilateral knee OA by MRI
- bilateral symptomatic knee OA (frequent bilateral knee pain > 15 days per month)
- BMI< 30.0 kg/m2
- male sex
- claustrophobia
- contraindication to MRI including body weight > 300 lbs or knee coil does not fit
- unwillingness or inability to change eating and physical activity habits due to environment
- cannot speak and read English
- planning to leave area > 2 months during the 48-month intervention period
Where it is running
- Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
- Wake Forest University — Winston-Salem, North Carolina, United States (enrolling)
- University of Sydney — Sydney, Australia (enrolling)
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
Full record on ClinicalTrials.gov
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