Preventing knee osteoarthritis through diet and exercise in obese women over 50

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of a combined intervention of dietary weight loss and exercise in preventing knee osteoarthritis (OA) in adult females aged 50 and older who are obese and experience little to no knee pain. Participants will be randomly assigned to either the intervention group or an attention control group, with the primary focus on assessing structural changes in the knee through MRI. Secondary outcomes will include pain levels, mobility, quality of life, and the cost-effectiveness of the intervention. The study will involve multiple sites, including locations in the U.S. and Australia, and will enroll approximately 1,230 participants.

Why it matters

Who can join: the full rules

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

Where it's running

• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting
• Wake Forest University
  Winston-Salem, North Carolina, United States Recruiting
• University of Sydney
  Sydney, Australia Recruiting
• University of North Carolina at Chapel Hill
  Chapel Hill, North Carolina, United States Active not recruiting

Study contacts

• Principal investigator: Stephen P Messier, Ph.D. — Wake Forest University
• Study coordinator: Jovita Newman
• Email: jollajk@wfu.edu
• Phone: 336-758-3969

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.