The Osteoarthritis Prevention Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age50+
SponsorWake Forest University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Diet and Exercise

    Behavioral

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

Treatment groups

1,230 Participants
are divided into 2 treatment groups
Group A: Attention ControlNo intervention 0 interventions
Group B: Diet and ExerciseExperimental treatment 1 intervention

Trial outcomes

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).

Time frame
Month 48

Secondary outcomes

1

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.

Time frame
Month 48
2

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.

Time frame
Month 48
3

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.

Time frame
Month 48

Other outcomes

1

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.

Time frame
Month 48
2

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.

Time frame
Month 48
3

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.

Time frame
Month 48
4

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.

Time frame
Month 48

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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