The Osteoarthritis Prevention Study

NCT05946044 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1230

Last updated 2025-07-23

No results posted yet for this study

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05946044 on ClinicalTrials.gov