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The Osteoarthritis Prevention Study for Women

This study is testing if a program of diet, exercise, and weight-loss maintenance can prevent knee osteoarthritis (OA) in women. You may be able to join if you are a woman aged 50 or older, have a BMI of 30 or higher, and have no or infrequent knee pain. The study will compare this program to a control group to see if it prevents changes in your knee as seen on an MRI after 48 months. The goal is to find ways to prevent OA, which is a common cause of disability.

Study design
This is an interventional study planning to enroll 1230 participants. It compares a diet and exercise program to an attention control group.
What's involved
The intervention involves group and individual weight loss and weight maintenance sessions combined with exercise throughout 48 months.
Compensation
Not stated in the trial record.
Follow-up
Your knee osteoarthritis will be assessed at Month 48.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05946044

The Osteoarthritis Prevention Study

Recruiting
NAAges 50+InterventionalPrevention
Wake Forest University
~1,230 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:Diet and Exercise

At a glance

Recruiting sites
3 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Structural knee Osteoarthritis (OA) MRI change Scores
Measured over Month 48

Conditions

Osteoarthritis, Knee

Explore related trials

Osteoarthritis

Where it's being run

4 sites across 3 states
North Carolina2
Massachusetts1
Australia1

Study leadership

  • Stephen P Messier, Ph.D. · PRINCIPAL_INVESTIGATOR · Wake Forest University

Who to contact

Jovita Newman
[email protected]
336-758-3969
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Structural knee Osteoarthritis (OA) MRI change ScoresMonth 48

    Compare the effects of a 48-month intervention of dietary weight loss, exercise, and weight-loss maintenance to an attention control group in preventing the development of structural (MRI) knee OA. Assessed using the MRI Osteoarthritis Knee Score (MOAKS). The MOAKS evaluates degenerative changes in the knee, including the location and severity of osteophyte formation, bone marrow lesions, and cartilage loss. The MOAKS classification system of osteophytes has grades ranging from 0 (none) to 3 (large).