The Osteoarthritis Prevention Study
- Conditions
- Osteoarthritis, Knee
- Registration Number
- NCT05946044
- Lead Sponsor
- Wake Forest University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 1230
Inclusion Criteria:<br><br> - Female<br><br> - BMI = 30 kg/m2<br><br> - An eligible knee will have no OA by xray and MRI<br><br> - No or infrequent knee pain (< 15 days/month) in the same knee<br><br>Exclusion Criteria:<br><br> - symptomatic or severe coronary artery disease<br><br> - unable to walk without a device<br><br> - blindness<br><br> - type 1 diabetes<br><br> - active treatment for cancer<br><br> - during the past 12 months knee fracture, anterior cruciate ligament (ACL), medial<br> collateral ligament (MCL), or meniscus injury with or without surgical repair<br><br> - knee injection during the past 6 months<br><br> - bilateral knee OA by x-ray Kellgren-Lawrence (KL) = 2<br><br> - bilateral knee OA by MRI<br><br> - bilateral symptomatic knee OA (frequent bilateral knee pain > 15 days per month)<br><br> - BMI< 30.0 kg/m2<br><br> - male sex<br><br> - claustrophobia<br><br> - contraindication to MRI including body weight > 300 lbs or knee coil does not fit<br><br> - unwillingness or inability to change eating and physical activity habits due to<br> environment<br><br> - cannot speak and read English<br><br> - planning to leave area > 2 months during the 48-month intervention period
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Structural knee Osteoarthritis (OA) MRI change Scores
- Secondary Outcome Measures
Name Time Method Knee Pain Scores;Mobility Scores;Health-Related Quality of Life Scores