The Osteoarthritis Prevention Study

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 50
Healthy Volunteers: t
View:

• 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

Locations
United States
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
Wake Forest University
RECRUITING
Winston-salem
Other Locations
Australia
University of Sydney
RECRUITING
Sydney
Contact Information
Primary
Jovita Newman
jollajk@wfu.edu
336-758-3969
Time Frame
Start Date: 2024-03-21
Estimated Completion Date: 2029-07-31
Participants
Target number of participants: 1230
Treatments
No_intervention: Attention Control
This comparison group provides attention, social interaction, and healthy lifestyle classes. There will be 4, 1-hour face-to-face group meetings per year featuring community health professionals, quarterly newsletters, and quarterly text messages.
Experimental: Diet and Exercise
The dietary component of the weight loss intervention is characterized by the frequency of contacts, methods to induce dietary restriction, and behavioral therapy strategies. The first 6 months of the diet program is an energy-restricted diet with the option of using partial meal replacements and nutritious snacks (Rapid Nutrition, PLC). The weight loss goal for the diet and exercise group is a minimum of 10% of baseline body weight by the end of year 1. The weight loss phase is followed by 3 years of a weight-loss maintenance program, with the goal of sustaining the achieved weight loss. The exercise component includes 60-minute sessions 2 days per week for 48 months.
Related Therapeutic Areas
Obesity
Arthritis
Osteoarthritis
Sponsors
Collaborators: Office of Behavioral and Social Sciences Research (OBSSR), Centers for Disease Control and Prevention, National Center for Complementary and Integrative Health (NCCIH), Rapid Nutrition PLC, Office of Disease Prevention, Office of Research on Women's Health (ORWH), Arthritis Foundation, University of Missouri-Columbia, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Leads: Wake Forest University

This content was sourced from clinicaltrials.gov

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