Diet and Exercise for Osteoarthritis Prevention

(TOPS Trial)

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by Stephen P Messier, Ph.D.

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Wake Forest University

Disqualifiers: Coronary artery disease, Type 1 diabetes, Cancer, others

No Placebo Group

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Diet and Exercise, Weight Loss Program, Exercise Therapy, Dietary Intervention for osteoarthritis prevention?

Research shows that combining diet and exercise can lead to significant weight loss and improve symptoms like knee pain and physical function in people with knee osteoarthritis. Weight loss is considered one of the best non-drug ways to slow down the progression of osteoarthritis. ^{1 2 3 4 5}

Is diet and exercise generally safe for humans?

Diet and exercise interventions are generally considered safe for humans, but restrictive dieting can have harmful effects. It's important to focus on developing a healthy lifestyle rather than just weight loss. ^{6 7 8 9 10}

How is the Diet and Exercise treatment for osteoarthritis different from other treatments?

The Diet and Exercise treatment for osteoarthritis is unique because it combines weight loss through dietary changes and physical activity to reduce pain and improve function, targeting inflammation and musculoskeletal health without relying on medication. ^{1 11 12 13 14}

Research Team

Stephen P Messier, Ph.D.

Principal Investigator

Wake Forest University

Eligibility Criteria

This trial is for women over 50 with obesity who have no or rare knee pain and no signs of knee osteoarthritis on X-rays or MRI. They must not be using walking aids, have a BMI ≥ 30 kg/m2, and can't be undergoing cancer treatment, have type 1 diabetes, severe heart issues, recent major knee injuries or surgeries.

Inclusion Criteria

I am female.

My knee does not show arthritis on X-ray or MRI.

I rarely have knee pain, less than 15 days a month.

Exclusion Criteria

Blindness

I experience pain in both knees for more than 15 days each month.

I am currently receiving treatment for cancer.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 48-month intervention of dietary weight loss, exercise, and weight-loss maintenance

48 months

Bi-weekly exercise sessions, quarterly group meetings

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Diet and Exercise (Behavioral Intervention)

Trial Overview The study tests if dieting to lose weight combined with exercise can prevent knee osteoarthritis in at-risk women. Participants will either follow this program or join an attention control group. The effects on their knees will be monitored through MRIs and other health measures.

Participant Groups

Group I: Diet and Exercise Experimental Treatment 1 Intervention

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.

Group II: Attention Control Active Control 1 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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of North Carolina at Chapel Hill Chapel Hill, NC

Brigham and Women's Hospital Boston, MA

Wake Forest University Winston-Salem, NC

Who Is Running the Clinical Trial?

Wake Forest University

Lead Sponsor

Trials

193

Patients Recruited

151,000+

Centers for Disease Control and Prevention

Collaborator

Trials

902

Patients Recruited

25,020,000+

University of Missouri-Columbia

Collaborator

Trials

387

Patients Recruited

629,000+

Arthritis Foundation

Collaborator

Trials

36

Patients Recruited

46,500+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Patients Recruited

677,000+

Office of Research on Women's Health (ORWH)

Collaborator

Trials

34

Patients Recruited

36,300+

Office of Behavioral and Social Sciences Research (OBSSR)

Collaborator

Trials

6

Patients Recruited

8,100+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Patients Recruited

1,090,000+

Office of Disease Prevention

Collaborator

Trials

1

Patients Recruited

1,200+

Rapid Nutrition PLC

Collaborator

Trials

1

Patients Recruited

1,200+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and weight loss in obese older adults with knee osteoarthritis: a preliminary study. Messier, SP., Loeser, RF., Mitchell, MN., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"It's the single best thing I've done in the last 10 years": a qualitative study exploring patient and dietitian experiences with, and perceptions of, a multi-component dietary weight loss program for knee osteoarthritis. Lawford, BJ., Bennell, KL., Jones, SE., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of weight maintenance on symptoms of knee osteoarthritis in obese patients: a twelve-month randomized controlled trial. Christensen, R., Henriksen, M., Leeds, AR., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight loss as treatment for knee osteoarthritis symptoms in obese patients: 1-year results from a randomised controlled trial. Bliddal, H., Leeds, AR., Stigsgaard, L., et al.[2011]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Intensive Diet and Exercise for Arthritis (IDEA) trial: design and rationale. Messier, SP., Legault, C., Mihalko, S., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect, process, and economic evaluation of a combined resistance exercise and diet intervention (ProMuscle in Practice) for community-dwelling older adults: design and methods of a randomised controlled trial. van Dongen, EJI., Haveman-Nies, A., Wezenbeek, NLW., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How effective are traditional dietary and exercise interventions for weight loss? Miller, WC.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effectiveness of diet-plus-exercise interventions vs. diet-only interventions for weight loss: a meta-analysis. Wu, T., Gao, X., Chen, M., et al.[2009]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise during and after very-low-calorie dieting. Phinney, SD.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise-focused versus weight-focused maintenance programs on the management of obesity. Leermakers, EA., Perri, MG., Shigaki, CL., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet-induced weight loss alone or combined with exercise in overweight or obese people with knee osteoarthritis: A systematic review and meta-analysis. Hall, M., Castelein, B., Wittoek, R., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of physical activity and dietary restriction interventions on weight loss and the musculoskeletal function of overweight and obese older adults with knee osteoarthritis: a systematic review and mixed method data synthesis. Alrushud, AS., Rushton, AB., Kanavaki, AM., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inflammatory cytokines mediate the effects of diet and exercise on pain and function in knee osteoarthritis independent of BMI. Runhaar, J., Beavers, DP., Miller, GD., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of lifestyle diet and exercise interventions for osteoarthritis. Messier, SP., Callahan, LF., Golightly, YM., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Exercise and weight loss in obese older adults with knee osteoarthritis: a preliminary study. [2022]

2. England pubmed.ncbi.nlm.nih.gov

"It's the single best thing I've done in the last 10 years": a qualitative study exploring patient and dietitian experiences with, and perceptions of, a multi-component dietary weight loss program for knee osteoarthritis. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Effect of weight maintenance on symptoms of knee osteoarthritis in obese patients: a twelve-month randomized controlled trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Weight loss as treatment for knee osteoarthritis symptoms in obese patients: 1-year results from a randomised controlled trial. [2011]

5. England pubmed.ncbi.nlm.nih.gov

The Intensive Diet and Exercise for Arthritis (IDEA) trial: design and rationale. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Effect, process, and economic evaluation of a combined resistance exercise and diet intervention (ProMuscle in Practice) for community-dwelling older adults: design and methods of a randomised controlled trial. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

How effective are traditional dietary and exercise interventions for weight loss? [2019]

8. England pubmed.ncbi.nlm.nih.gov

Long-term effectiveness of diet-plus-exercise interventions vs. diet-only interventions for weight loss: a meta-analysis. [2009]

9. United States pubmed.ncbi.nlm.nih.gov

Exercise during and after very-low-calorie dieting. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Effects of exercise-focused versus weight-focused maintenance programs on the management of obesity. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Diet-induced weight loss alone or combined with exercise in overweight or obese people with knee osteoarthritis: A systematic review and meta-analysis. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Effect of physical activity and dietary restriction interventions on weight loss and the musculoskeletal function of overweight and obese older adults with knee osteoarthritis: a systematic review and mixed method data synthesis. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Inflammatory cytokines mediate the effects of diet and exercise on pain and function in knee osteoarthritis independent of BMI. [2020]

14. England pubmed.ncbi.nlm.nih.gov

OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of lifestyle diet and exercise interventions for osteoarthritis. [2022]