Weight Loss for Knee Health in Obese Individuals

(ROCCK Trial)

Overseen By Alyssa King, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Lower extremity injury, Knee OA, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 6 months

88 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Weight Loss for improving knee health in obese individuals?

Research shows that weight loss can improve physical function and reduce symptoms in obese individuals with knee osteoarthritis, suggesting it may be effective for knee health. ^{1 2 3 4 5}

Is weight loss safe for obese individuals with knee issues?

Research shows that weight loss programs before knee surgery are generally safe and can lead to improved health and quality of life. One study found that patients maintained weight loss and had better knee function and quality of life after surgery. ^{2 4 6 7 8}

How does weight loss treatment differ from other treatments for knee osteoarthritis in obese individuals?

Weight loss is unique because it directly addresses the root cause of knee osteoarthritis in obese individuals by reducing the stress on the knee joints, potentially improving knee function and even benefiting the cartilage. Unlike other treatments that may focus on symptom relief, weight loss aims for a long-term improvement by targeting obesity, which is a major contributing factor to the condition. ^{2 5 9 10 11}

What is the purpose of this trial?

This trial aims to see if losing weight can improve knee joint health in obese individuals aged 18-45. Participants will follow a weight loss program to reduce stress on their knee joints, potentially restoring cartilage and improving function.

Research Team

Lou DeFrate

Principal Investigator

Duke University

Eligibility Criteria

This trial is for adults aged 18-45 with obesity (BMI of 29 to less than 40) who do not have symptoms of knee osteoarthritis, no history of lower extremity injury, and can fit in an MRI machine. Pregnant individuals or those with metal implants are excluded.

Inclusion Criteria

BMI between 29 and 40

Exclusion Criteria

I experience symptoms of knee arthritis.

Body waist fit in MRI

My thigh does not fit in the MRI machine.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo a 6-month weight loss intervention or wellness education program

6 months

Weekly group sessions and weigh-ins

Follow-up

Participants are monitored for changes in body composition and cartilage health

3 months

Monthly check-ins

Open-label extension (optional)

Participants may opt into continuation of weight management strategies

Long-term

Treatment Details

Interventions

• Weight Loss

Trial Overview The study investigates if weight loss can restore cartilage composition and function in obese individuals. Participants will undergo MR Imaging, gait analysis for joint loading, cartilage strain measurement, and a weight loss program.

Participant Groups

Group I: Weight-Loss Experimental Treatment 1 Intervention

Participants in the weight-loss intervention arm of the study will be enrolled in an individualized 6-month intervention designed to achieve a 10% reduction of body weight relative to baseline. Each participant receives a calorie (kcal) prescription derived from calculations of estimated total energy expenditure (TEE) based on weight, height, sex, age, and activity level using equations developed by the Institute of Medicine \[29\]. Prescribed kcal levels are adjusted downward from the TEE to achieve a weekly weight loss of 1 to 2 pounds, generally a deficit of 500-1000 kcal/day. Intervention activities include individual diet counseling, group support, goal setting, self-monitoring, stress management, and problem solving. Weekly group support and education sessions, along with daily food journaling and weekly weigh-ins, are recognized approaches for successful weight loss \[30-32\]. Once the weight loss goal is achieved, diets will be liberalized for weight maintenance.

Group II: Wellness Education Active Control 1 Intervention

Control participants will be counseled to maintain their baseline body weight and level of physical activity. They will report weights weekly and if their weight deviates from baseline they will be asked to keep daily food logs and counseled to return calorie intakes to weight maintenance level. To document diet intakes/adherence, 3-day food records will be collected at months 0, 3, and 6 and analyzed for calorie and nutrient composition. Participants will be encouraged not to change their physical activity levels from baseline and their activity will be monitored by Actigraph activity monitors worn in 7-day periods at months 0, 3, and 6. In addition, each participant will be invited to enter the weight loss intervention after completion of the health education control course.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Findings from Research

A seven-year follow-up study of 49 patients who underwent total knee arthroplasty (TKA) found that those who participated in a preoperative weight loss program could not maintain their weight loss long-term, gaining an average of 3.1 kg more than the control group.

Despite the inability to maintain weight loss, both groups showed significant improvements in pain, knee function, and health-related quality of life after TKA, indicating that weight loss prior to surgery may still have short-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term results after weight loss intervention in knee arthroplasty patients with obesity. Thomasen, A., Mechlenburg, I., Laursen, JO., et al.[2022]

In a study of 66 total knee replacements in morbidly obese women, only 57% achieved excellent or good results, compared to 86% in nonobese women, indicating that while knee replacement is safe for morbidly obese patients, the outcomes are less favorable than for nonobese patients.

The study found no significant weight loss in morbidly obese patients after knee replacement surgery, suggesting that the procedure should not be viewed as a method for facilitating weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knee replacement in morbidly obese women. Pritchett, JW., Bortel, DT.[2009]

References

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

The effects of weight reduction on the rehabilitation of patients with knee osteoarthritis and obesity. [2019]

2. France pubmed.ncbi.nlm.nih.gov

A critical review of weight loss recommendations before total knee arthroplasty. [2021]

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

Intensive weight loss program improves physical function in older obese adults with knee osteoarthritis. [2008]

4. Pakistan pubmed.ncbi.nlm.nih.gov

Evaluating the effect of obesity on total knee arthroplasty: A longitudinal study. [2019]

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

Weight loss: the treatment of choice for knee osteoarthritis? A randomized trial. [2022]

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

Liraglutide after diet-induced weight loss for pain and weight control in knee osteoarthritis: a randomized controlled trial. [2023]

7. Denmark pubmed.ncbi.nlm.nih.gov

Long-term results after weight loss intervention in knee arthroplasty patients with obesity. [2022]

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

Effects of meaningful weight loss beyond symptomatic relief in adults with knee osteoarthritis and obesity: a systematic review and meta-analysis. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Osteoarthritis - a role for weight management in rheumatology practice: an update. [2018]

10. Denmark pubmed.ncbi.nlm.nih.gov

[Osteoarthritis and obesity. Prognosis and treatment possibilities]. [2006]

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

Knee replacement in morbidly obese women. [2009]