Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1230 participants
INTERVENTIONAL
2024-03-21
2029-07-31
Brief Summary
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Detailed Description
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Participants will be 1,230 ambulatory, community dwelling females with obesity (BMI ≥ 30 kg/m2), and aged ≥ 50 years. Structural and symptomatic eligibility will be determined at the individual knee level. The eligible knee will have no radiographic (Kellgren Lawrence (KL) score ≤ 1) and no MRI knee OA with no or infrequent knee pain (\< 15 days/month) in the same knee. The primary aim is to 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 using the MRI OA Knee Score (MOAKS). Secondary aims will determine the intervention effects on the Knee Injury and Osteoarthritis Outcome Score (KOOS) pain, mobility (6 minute walk distance), and health-related quality of life (SF-36). Mechanistic secondary outcomes include knee joint compressive forces as a measure of joint loading, IL-6 as an inflammatory measure, and weight loss and exercise self-efficacy. A cost-effectiveness analysis will establish the value of the 48-month D+E (diet and exercise) intervention.
This study is significant in that it will test a critically needed primary prevention intervention of dietary weight loss, exercise, and weight-loss maintenance for females at risk for the development of knee OA designed to reduce incident structural knee OA compared to an attention control group, and intended to maximize health benefits at a reasonable cost.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
No interventions assigned to this group
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.
Diet and Exercise
Group and individual weight loss and weight maintenance sessions combined with exercise throughout the 48 months.
Interventions
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Diet and Exercise
Group and individual weight loss and weight maintenance sessions combined with exercise throughout the 48 months.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* cannot speak and read English
* planning to leave area \> 2 months during the 48-month intervention period
50 Years
FEMALE
Yes
Sponsors
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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
Arthritis Foundation
OTHER
National Center for Complementary and Integrative Health (NCCIH)
NIH
Office of Disease Prevention
UNKNOWN
Office of Research on Women's Health (ORWH)
NIH
Office of Behavioral and Social Sciences Research (OBSSR)
NIH
Centers for Disease Control and Prevention
FED
University of Missouri-Columbia
OTHER
Rapid Nutrition PLC
UNKNOWN
Wake Forest University
OTHER
Responsible Party
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Principal Investigators
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Stephen P Messier, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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IRB00080136
Identifier Type: -
Identifier Source: org_study_id
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