About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
symptomatic or severe coronary artery disease
unable to walk without a device
blindness
type 1 diabetes
Trial design
Parallel
Treatments tested in this trial
Diet and Exercise
BehavioralGroup and individual weight loss and weight maintenance sessions combined with exercise throughout the 48 months.
Treatment groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
Knee Pain Scores
Compare the effects of a 48-month intervention of dietary weight loss, exercise and weight-loss maintenance to an attention control group on the Knee Injury and Osteoarthritis Outcome Score (KOOS pain). Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score is calculated for the pain subscale. We will transform the score to a 0-100 scale, with 100 representing the most pain and 0 representing no pain.
Mobility Scores
Compare the effects of a 48-month intervention of dietary weight loss, exercise and weight-loss maintenance to an attention control group on 6-minute walk distance. Assessment of 6 minute walk distance (measured in meters). Greater distance indicates better mobility.
Health-Related Quality of Life Scores
Compare the effects of a 48-month intervention of dietary weight loss, exercise and weight-loss maintenance to an attention control group on health-related quality of life (SF-36). Questions from the SF-36 yield 2 broad summary scores: physical health and mental health. Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
Other outcomes
Knee Joint Loading Number
Compare the effects of a 48-month intervention of dietary weight loss, exercise, and weight-loss maintenance to an attention control group on knee joint compressive loads (Newtons). Higher numbers indicate greater loads.
Inflammation Value
Compare the effects of a 48-month intervention of dietary weight loss, exercise, and weight-loss maintenance to an attention control group on plasma Interleukin-6 (IL-6). Higher values indicate more inflammation.
Self-Efficacy Scores - exercise
Compare the effects of a 48-month intervention of dietary weight loss, exercise, and weight-loss maintenance to an attention control group on exercise self-efficacy. Exercise self efficacy will be measured using the walking efficacy for duration scale measures one's ability to walk/jog at a moderately fast pace for various durations. Range 0-100. A higher score indicates a higher self-efficacy. indicate better self-efficacy.
Self-Efficacy Scores - weight loss
Compare the effects of a 48-month intervention of dietary weight loss, exercise, and weight-loss maintenance to an attention control group on weight loss self-efficacy. Weight-loss self efficacy will be measured by the weight efficacy lifestyle questionnaire. A 20-item measure developed to assess self-efficacy for weight management. Participants are asked to rate their confidence to resist the desire to eat using a 10-point scale ranging from 0 not confident to 9 very confident. Total scores range from 0-180. Higher scores indicate better self-efficacy.
Sponsors and contacts
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Wake Forest University
Lead sponsor
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