The Osteoarthritis Prevention Study
NCT05946044 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1230
Last updated 2025-07-23
Summary
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
Interventions
- BEHAVIORAL
-
Diet and Exercise
Group and individual weight loss and weight maintenance sessions combined with exercise throughout the 48 months.
Sponsors & Collaborators
-
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
collaborator NIH -
Arthritis Foundation
collaborator OTHER -
National Center for Complementary and Integrative Health (NCCIH)
collaborator NIH -
Office of Disease Prevention
collaborator UNKNOWN -
Office of Research on Women's Health (ORWH)
collaborator NIH -
Office of Behavioral and Social Sciences Research (OBSSR)
collaborator NIH -
Centers for Disease Control and Prevention
collaborator FED -
University of Missouri-Columbia
collaborator OTHER -
Rapid Nutrition PLC
collaborator UNKNOWN -
Wake Forest University
lead OTHER
Principal Investigators
-
Stephen P Messier, Ph.D. · Wake Forest University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-03-21
- Primary Completion
- 2029-07-31
- Completion
- 2029-07-31
Countries
- United States
- Australia
Study Locations
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