The Osteoarthritis Prevention Study

NCT05946044 | Recruiting DMC

• 2 other identifiers: IRB00080136U01AR082121-01
• Study Type: interventional
• Target: 1,230
• Locations: 2 countries
• Sites: 4

Brief 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

Keywords

Obesity; Knee Pain

Outcome Measures

Primary Outcomes (1)

• Structural knee Osteoarthritis (OA) MRI change Scores

  Compare the effects of a 48-month intervention of dietary weight loss, exercise, and weight-loss maintenance to an attention control group in preventing the development of structural (MRI) knee OA. Assessed using the MRI Osteoarthritis Knee Score (MOAKS). The MOAKS evaluates degenerative changes in the knee, including the location and severity of osteophyte formation, bone marrow lesions, and cartilage loss. The MOAKS classification system of osteophytes has grades ranging from 0 (none) to 3 (large).

  Month 48

Secondary Outcomes (3)

• Knee Pain Scores

  Month 48

• Mobility Scores

  Month 48

• Health-Related Quality of Life Scores

  Month 48

Other Outcomes (5)

• Knee Joint Loading Number

  Month 48

• Inflammation Value

  Month 48

• Self-Efficacy Scores - exercise

  Month 48

Study Arms (2)

Attention Control

NO INTERVENTION

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.

Diet and Exercise

EXPERIMENTAL

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.

Behavioral: Diet and Exercise

Interventions

Diet and Exercise BEHAVIORAL

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

Diet and Exercise

Eligibility Criteria

• Age: 50 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• symptomatic or severe coronary artery disease
• unable to walk without a device
• blindness
• type 1 diabetes
• active treatment for cancer
• during the past 12 months knee fracture, anterior cruciate ligament (ACL), medial collateral ligament (MCL), or meniscus injury with or without surgical repair
• knee injection during the past 6 months
• bilateral knee OA by x-ray Kellgren-Lawrence (KL) ≥ 2
• bilateral knee OA by MRI
• bilateral symptomatic knee OA (frequent bilateral knee pain \> 15 days per month)
• BMI\< 30.0 kg/m2
• male sex
• claustrophobia
• contraindication to MRI including body weight \> 300 lbs or knee coil does not fit
• unwillingness or inability to change eating and physical activity habits due to environment

Sponsors & Collaborators

• Wake Forest University: lead
• 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

Study Sites (4)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27516, United States

RECRUITING

Wake Forest University

Winston-Salem, North Carolina, 27109, United States

RECRUITING

University of Sydney

Sydney, Australia

RECRUITING

Related Publications (1)

• Messier SP, Callahan LF, Losina E, Mihalko SL, Guermazi A, Ip E, Miller GD, Katz JN, Loeser RF, Pietrosimone BG, Soto S, Cook JL, Newman JJ, DeVita P, Spindler KP, Runhaar J, Armitano-Lago C, Duong V, Selzer F, Hill R, Love M, Beavers DP, Saldana S, Stoker AM, Rice PE, Hunter DJ. The osteoarthritis prevention study (TOPS) - A randomized controlled trial of diet and exercise to prevent Knee Osteoarthritis: Design and rationale. Osteoarthr Cartil Open. 2023 Nov 20;6(1):100418. doi: 10.1016/j.ocarto.2023.100418. eCollection 2024 Mar.

  PMID: 38144515 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Obesity

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Stephen P Messier, Ph.D.

  Wake Forest University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jovita Newman

CONTACT

336-758-3969; jollajk@wfu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: assessor-blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 14, 2023
• Study Start: March 21, 2024
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2029
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Investigators whose proposed use of the data has been approved by the study P\&P committee. Proposals should be directed to the study PI, Stephen Messier at messier@wfu.edu or the central contact.

Locations

US (3); AU (1)