RecruitingNot ApplicableNCT05946044

The Osteoarthritis Prevention Study


Sponsor

Wake Forest University

Enrollment

1,230 participants

Start Date

Mar 21, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This large multicenter clinical trial is testing whether a combined program of dietary weight loss, exercise, and long-term weight maintenance can prevent knee osteoarthritis from developing in women who are at high risk due to obesity. Participants are women aged 50 and older with obesity (BMI of 30 or above) who do not yet have knee osteoarthritis and have little or no knee pain, and the primary measure of success is whether the intervention reduces changes visible on knee MRI scans over 48 months. Women must be ambulatory, free of active cancer, and able to change their eating and activity habits to participate, among other criteria. Participation involves following a structured diet and exercise program for 4 years and attending regular clinic visits for MRI scans, function tests, and questionnaires. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALDiet and Exercise

Group and individual weight loss and weight maintenance sessions combined with exercise throughout the 48 months.


Locations(4)

Brigham and Women's Hospital

Boston, Massachusetts, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Wake Forest University

Winston-Salem, North Carolina, United States

University of Sydney

Sydney, Australia

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NCT05946044


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