Actively Recruiting
The Osteoarthritis Prevention Study
Led by Wake Forest University · Updated on 2025-07-23
1230
Participants Needed
4
Research Sites
279 weeks
Total Duration
On this page
Sponsors
W
Wake Forest University
Lead Sponsor
N
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
The Osteoarthritis Prevention Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27516
Actively Recruiting
3
Wake Forest University
Winston-Salem, North Carolina, United States, 27109
Actively Recruiting
4
University of Sydney
Sydney, Australia
Actively Recruiting
Research Team
J
Jovita Newman
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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