RECRUITING

The Osteoarthritis Prevention Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

The Osteoarthritis Prevention Study

Quick Facts

Study Start:2024-03-21
Study Completion:2028-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05946044

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.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female
  2. * BMI ≥ 30 kg/m2
  3. * An eligible knee will have no OA by xray and MRI
  4. * No or infrequent knee pain (\< 15 days/month) in the same knee
  1. * symptomatic or severe coronary artery disease
  2. * unable to walk without a device
  3. * blindness
  4. * type 1 diabetes
  5. * active treatment for cancer
  6. * during the past 12 months knee fracture, anterior cruciate ligament (ACL), medial collateral ligament (MCL), or meniscus injury with or without surgical repair
  7. * knee injection during the past 6 months
  8. * bilateral knee OA by x-ray Kellgren-Lawrence (KL) ≥ 2
  9. * bilateral knee OA by MRI
  10. * bilateral symptomatic knee OA (frequent bilateral knee pain \> 15 days per month)
  11. * BMI\< 30.0 kg/m2
  12. * male sex
  13. * claustrophobia
  14. * contraindication to MRI including body weight \> 300 lbs or knee coil does not fit
  15. * unwillingness or inability to change eating and physical activity habits due to environment
  16. * cannot speak and read English
  17. * planning to leave area \> 2 months during the 48-month intervention period

Contacts and Locations

Study Contact

Jovita Newman
CONTACT
336-758-3969
jollajk@wfu.edu

Principal Investigator

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

Study Locations (Sites)

Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27516
United States
Wake Forest University
Winston-Salem, North Carolina, 27109
United States

Collaborators and Investigators

Sponsor: Wake Forest University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-21
Study Completion Date2028-07-31

Study Record Updates

Study Start Date2024-03-21
Study Completion Date2028-07-31

Terms related to this study

Keywords Provided by Researchers

  • Obesity
  • Knee Pain

Additional Relevant MeSH Terms

  • Osteoarthritis, Knee