| NCT ID | NCT05946044 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wake Forest University |
| Condition | Osteoarthritis, Knee |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,230 participants |
| Start Date | 2024-03-21 |
| Primary Completion | 2029-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,230 participants in total. It began in 2024-03-21 with a primary completion date of 2029-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Stephen P Messier, Ph.D.
PRINCIPAL INVESTIGATOR
Wake Forest University
Frequently Asked Questions
Who can join the NCT05946044 clinical trial?
This trial is open to female participants only, aged 50 Years or older, studying Osteoarthritis, Knee. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05946044 currently recruiting?
Yes, NCT05946044 is actively recruiting participants. Contact the research team at jollajk@wfu.edu for enrollment information.
Where is the NCT05946044 trial being conducted?
This trial is being conducted at Boston, United States, Chapel Hill, United States, Winston-Salem, United States, Sydney, Australia.
Who is sponsoring the NCT05946044 clinical trial?
NCT05946044 is sponsored by Wake Forest University. The principal investigator is Stephen P Messier, Ph.D. at Wake Forest University. The trial plans to enroll 1,230 participants.