The Osteoarthritis Prevention Study
ConditionOsteoarthritis, Knee
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age50+
SponsorWake Forest University
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
symptomatic or severe coronary artery disease
unable to walk without a device
blindness
type 1 diabetes
Trial design
Treatments tested in this trial
- Diet and Exercise
Treatment groups
1,230 Participants
are divided into 2 treatment groupsSponsors and collaborators
Wake Forest University
Lead sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
Arthritis Foundation
Collaborator
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Office of Disease Prevention
Collaborator
Office of Research on Women's Health (ORWH)
Collaborator
Office of Behavioral and Social Sciences Research (OBSSR)
Collaborator
Centers for Disease Control and Prevention
Collaborator
University of Missouri-Columbia
Collaborator
Rapid Nutrition PLC
Collaborator
Source ClinicalTrials.gov