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Recruiting
NCT05946044
The Osteoarthritis Prevention Study
Conditions: Osteoarthritis, Knee
Sex: Female
Ages: 50 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 1230
Sponsor: Wake Forest University
Location: Brigham and Women's Hospital Boston Massachusetts
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
Source: ClinicalTrials.gov (NCT05946044). StuddyBuddy aggregates publicly available trial information.