The Osteoarthritis Prevention Study
Recruiting · NCT05946044 · Interventional (participants receive a specific treatment) · Lead sponsor: Wake Forest University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- 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
4 locations listed across 2 US states.
- Brigham and Women's Hospital - Boston, Massachusetts, United States
- University of North Carolina at Chapel Hill - Chapel Hill, North Carolina, United States
- Wake Forest University - Winston-Salem, North Carolina, United States
- University of Sydney - Sydney, Australia