RecruitingNot applicable

The Osteoarthritis Prevention Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years and older
Sex
Female only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "The primary aim is to compare the effects of a 48-month intervention of dietary weight loss, exercise, and weight-loss maintenance to an attention control group in preventing the development of structural (MRI) knee OA using the MRI OA Knee Score (MOAKS)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether weight loss through diet, exercise, and keeping weight off can prevent knee osteoarthritis, a disease that damages joints. It is for women age 50 or older with obesity and little or no knee pain. Researchers will use MRI scans to look for knee joint damage.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women age 50 or older.
  • Have a body mass index (BMI) of 30 or higher, which is in the obesity range.
  • Have a knee with no osteoarthritis on X-rays or MRI scans.
  • Have pain in that same knee on fewer than 15 days per month, or no pain.

Who can't join

  • Have heart artery disease that causes symptoms or is severe, type 1 diabetes, blindness, or are getting cancer treatment.
  • Cannot walk without a device, such as a cane or walker.
  • Had a knee fracture or an injury to major knee ligaments or cartilage in the past 12 months, with or without surgery; or had a knee injection in the past 6 months.
  • Have osteoarthritis in both knees on X-rays or MRI scans, or have arthritis pain in both knees on more than 15 days per month.
  • Are male or have a BMI below 30.
  • Have a fear of tight spaces or cannot have an MRI, including because you weigh more than 300 pounds or the MRI knee equipment does not fit.
  • Are unwilling to change eating and exercise habits, or your surroundings prevent these changes; or cannot speak and read English.
  • Plan to leave the area for more than 2 months during the 48-month study program.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (3)

MA

NC