RECRUITING

The Osteoarthritis Prevention Study

Description

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.

Conditions

Osteoarthritis, Knee
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Related Conditions:

Osteoarthritis, Knee

Study Overview

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Study Details

Study overview

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.

The Osteoarthritis Prevention Study

The Osteoarthritis Prevention Study

Condition
Osteoarthritis, Knee
Intervention / Treatment

-

Contacts and Locations

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02115

Chapel Hill

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States, 27516

Winston-Salem

Wake Forest University, Winston-Salem, North Carolina, United States, 27109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

50 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Wake Forest University,

Stephen P Messier, Ph.D., PRINCIPAL_INVESTIGATOR, Wake Forest University

Study Record Dates

2028-07-31