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Clinical Trials in Australia / NCT05946044
Recruiting Not applicable

The Osteoarthritis Prevention Study

NCT05946044 · tracked via the Priya Life Science Australia tracker
Sponsor
Wake Forest University
Phase
Not applicable
Started
2024-03-21
Last updated
2026-07-23

Condition(s) studied

Osteoarthritis, Knee

Investigational drug(s) / intervention(s)

Diet and Exercise

Diet and Exercise: Group and individual weight loss and weight maintenance sessions combined with exercise throughout the 48 months.

Study 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

Sex
FEMALE
Min age
50 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
Brigham and Women's Hospital Boston Massachusetts Recruiting
University of North Carolina at Chapel Hill Chapel Hill North Carolina Active Not Recruiting
Wake Forest University Winston-Salem North Carolina Recruiting
University of Sydney Sydney Australia Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05946044 on ClinicalTrials.gov ↗ ← All trials in Australia