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The Osteoarthritis Prevention Study

RECRUITINGN/ASponsored by Wake Forest University
Actively Recruiting
PhaseN/A
SponsorWake Forest University
Started2024-03-21
Est. completion2029-07-31
Eligibility
Age50 Years+
SexFEMALE
Healthy vol.Accepted
Locations3 sites

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

Age: 50 Years+Sex: FEMALEHealthy 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

Conditions2

ArthritisOsteoarthritis, Knee

Locations3 sites

Massachusetts

1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Paul Oh617-525-8349paoh@bwh.harvard.edu

North Carolina

2 sites
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27516
Cortney Armitano-Lago919-962-2025Cortney_Lago@med.unc.edu
Wake Forest University
Winston-Salem, North Carolina, 27109
Jovita Newman336-758-3969jollajk@wfu.edu

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