NCT05946044 · Wake Forest University
The Osteoarthritis Prevention Study
(TOPS)
What this study is about
The goal of this study is to establish the effectiveness 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.
View original scientific description
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 participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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
- 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
- Boston, Massachusetts
- Chapel Hill, North Carolina
- Winston-Salem, North Carolina
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 23, 2025 · Source of record for eligibility and locations