Preventing knee osteoarthritis through diet and exercise in obese women over 50
The Osteoarthritis Prevention Study
This study is testing if a weight loss diet and exercise can help prevent knee osteoarthritis in obese women over 50 who don’t have much knee pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1230 (estimated) |
| Ages | 50 Years and up |
| Sex | Female |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 4 sites (Boston, Massachusetts and 3 other locations) |
| Trial ID | NCT05946044 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a combined intervention of dietary weight loss and exercise in preventing knee osteoarthritis (OA) in adult females aged 50 and older who are obese and experience little to no knee pain. Participants will be randomly assigned to either the intervention group or an attention control group, with the primary focus on assessing structural changes in the knee through MRI. Secondary outcomes will include pain levels, mobility, quality of life, and the cost-effectiveness of the intervention. The study will involve multiple sites, including locations in the U.S. and Australia, and will enroll approximately 1,230 participants.
Who should consider this trial
Good fit: Ideal candidates for this study are adult females aged 50 and older with a BMI of 30 or higher, who have no or infrequent knee pain.
Not a fit: Patients with existing knee osteoarthritis, severe coronary artery disease, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the incidence of knee osteoarthritis in at-risk populations, improving quality of life and reducing healthcare costs.
How similar studies have performed: Previous studies have shown that dietary weight loss and exercise can effectively manage knee osteoarthritis symptoms, suggesting this preventive approach may also be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Boston, Massachusetts and 3 other locations
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
- Wake Forest University — Winston-Salem, North Carolina, United States (Recruiting)
- University of Sydney — Sydney, Australia (Recruiting)
Study contacts
- Principal investigator: Stephen P Messier, Ph.D. — Wake Forest University
- Study coordinator: Jovita Newman
- Email: jollajk@wfu.edu
- Phone: 336-758-3969
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.