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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how weight loss affects knee health in individuals with obesity. Researchers seek to determine if losing weight can improve cartilage condition, the smooth tissue in joints that facilitates movement. Participants will either join a weight-loss program or receive wellness education. Suitable candidates are adults aged 18 to 45 with a BMI of 29 or higher, who do not have knee injuries or symptoms of osteoarthritis. Participants will engage in activities such as MR imaging, walking tests, and weight-loss interventions. As an unphased trial, this study provides participants the chance to contribute to significant research that may lead to better knee health solutions for people with obesity.

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 prior data suggests that this weight loss intervention is safe for knee health in obese individuals?

Research has shown that losing weight can safely and effectively help manage knee osteoarthritis (OA). Studies have found that shedding pounds can ease knee pain and improve knee function. For instance, one study discovered that losing just 5.1 kg (about 11 lbs) can reduce the risk of developing knee OA by half over 10 years.

While losing weight is generally safe, some risks exist. Rapid weight loss might lead to joint instability, loss of muscle and bone, or poor nutrition. However, the weight loss program in this study is designed to be gradual and controlled. Participants aim to lose 1 to 2 pounds per week, which is considered a safe pace.

Overall, losing weight is well-tolerated and can effectively manage knee OA symptoms without medication. ^{1 2 3 4}

Why are researchers excited about this trial?

Researchers are excited about the weight loss intervention for knee health because it offers a comprehensive and personalized approach to weight management. Unlike standard care options that may focus solely on diet or exercise separately, this treatment combines individualized calorie prescriptions, diet counseling, stress management, and group support to achieve a significant and sustained reduction in body weight. This holistic method not only targets weight loss but also emphasizes long-term maintenance, which can potentially lead to improved knee health outcomes for individuals with obesity.

What evidence suggests that weight loss might be an effective treatment for knee health in obese individuals?

Research has shown that losing weight can greatly benefit people with knee osteoarthritis (OA), especially those who are obese. One study found that shedding just 5% of body weight lessened knee pain and improved knee function. Another study found that losing about 11 pounds reduced the risk of developing knee OA by 50% over ten years for women. Even a small amount of weight loss can alter the disease's progression. In this trial, participants in the weight-loss intervention arm will aim for a 10% reduction in body weight, aligning with evidence that both moderate and significant weight loss can help reduce knee pain and improve knee health in people with obesity. ^{2 3 4 5 6}

Who Is on the Research Team?

Lou DeFrate

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10746515/

The osteoarthritis prevention study (TOPS) - PMC These results suggest that in people with obesity, even relatively small amounts of weight loss can potentially portend disease-modifying ...

2. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2799405

Effect of Diet and Exercise on Knee Pain in Patients With ... Moderate (5%) to intensive (10%) weight loss in patients with knee OA and obesity achieved in previous academic center–based efficacy trials ...

3. jrheum.org jrheum.org/content/51/3/224

The Critical Role of Physical Activity and Weight ... In the Framingham Study, a weight loss of 5.1 kg (11.2 lbs) reduced women's risk of developing knee OA by 50% over 10 years. Further, prevention ...

4. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT00381290

Intensive Diet and Exercise for Improving Knee ... The purpose of this study is to compare the effects of a calorie-restricting diet, exercise, and a combination of both in reducing knee inflammation and ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1063458425000238

Comparison of weight loss interventions in overweight and ... Comparing video-based, telehealth-delivered exercise and weight loss programs with online education on outcomes of knee osteoarthritis: a randomized trial.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12183455/

Weight Loss & Osteoarthritis: Risks & Challenges Rapid weight loss may destabilise joints, lead to muscle and bone loss, and increase the risk of malnutrition and osteoporosis.