No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
50 and older
Sex
Female
Study type
Interventional
Purpose
Prevention
Participants needed
1,230 (estimated)
Sponsor
Wake Forest University · Other
Who this trial is looking for
This trial is looking for adult women aged 50 and older who are obese but have little to no knee pain. Participants will engage in a program involving weight loss, exercise, and maintaining their weight to help prevent knee osteoarthritis.
Are You a Good Fit for This Trial?
Rules you outBilateral knee osteoarthritisClaustrophobiaContraindication to MRI
You may be able to join if
I am female
I have a BMI of 30 or greater
I have no knee osteoarthritis on x-ray or MRI
I have little to no knee pain, less than 15 days a month
You may not be able to join if
I have symptomatic or severe coronary artery disease
I cannot walk without a walking device
I am blind
I have type 1 diabetes
I am receiving treatment for cancer
I have had a knee injury in the past year
I have had a knee injection in the past 6 months
I have a BMI of less than 30
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 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.
Trial Locations
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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
* a…
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
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