Weight Loss Intervention for Obesity Before Knee Surgery

Overseen By Jeff Honas, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Cancer, Diabetes Type 1, Renal insufficiency, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if losing weight before knee replacement surgery improves recovery and reduces complications. It involves two groups: one will follow a special weight loss plan called the Multi-Component Weight Loss Intervention before surgery and maintain the weight afterward, while the other will receive standard care without specific diet advice. The trial targets individuals scheduled for knee surgery with a BMI between 35 and 40 who are patients at the University of Kansas Health System. Participants must have access to a Bluetooth-enabled device to join remote sessions. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance surgical outcomes for future patients.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does list certain health conditions that would exclude you from participating, such as untreated hyperuricemia, active inflammatory bowel disease, and others. It's best to discuss your specific medications with the trial coordinators.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this weight loss intervention is safe for individuals undergoing knee surgery?

Research has shown that a weight loss program before knee surgery is safe for patients. One study found that following a strict weight loss plan, including a very low-calorie diet and counseling, is possible and safe just before knee replacement surgery.

Another study suggested that losing weight and exercising can reduce knee pain for people with osteoarthritis. This approach not only alleviates pain but also improves outcomes after knee surgery.

Overall, past patients found this type of weight loss program manageable. These studies reported no major safety issues, allowing prospective participants to feel confident about its safety based on past research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the multi-component weight loss intervention for obesity before knee surgery because it offers a holistic approach, combining dietary changes, physical activity, and behavioral strategies. Unlike standard care, which often focuses solely on surgery preparation, this intervention aims to reduce weight and improve overall health, potentially leading to better surgical outcomes and faster recovery. By addressing multiple lifestyle factors, it not only targets weight loss but also enhances patients' long-term well-being.

What evidence suggests that this trial's treatments could be effective for obesity before knee surgery?

Research has shown that losing weight before knee surgery can lead to better outcomes. Studies have found that combining weight loss with exercise can help reduce knee pain from osteoarthritis. In this trial, participants in the intervention arm will follow a multi-component weight loss plan, including a very-low-calorie diet, exercise, and behavior counseling. This approach has successfully helped people lose weight and improve mobility. Although direct evidence on its impact on knee surgeries is limited, weight loss is known to lower the risk of surgical complications such as infections and pain. This comprehensive approach offers a thorough preparation for surgery. ^{1 4 5 6 7}

Who Is on the Research Team?

Steve Herrmann, PhD

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals aged 50-75 with a BMI of 35 to ≤40 kg/m2, scheduled for total knee replacement surgery at KUOrtho and able to participate in remote sessions via Bluetooth-enabled devices. It's not suitable for those outside this age and BMI range or without the required technology.

Inclusion Criteria

I am a patient at KUOrtho and meet all requirements for knee replacement surgery.

I own a device capable of telehealth sessions and syncing with health monitors.

My knee replacement surgery is scheduled for 3 months or more from now.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgical Weight Loss Intervention

Participants undergo a multi-component weight loss intervention including a very low-calorie diet, increased physical activity, and individual behavior counseling

12 weeks

Regular virtual counseling sessions

Surgery and Immediate Post-surgical Period

Participants undergo Total Knee Arthroplasty (TKA) and are monitored for immediate post-surgical recovery

2 weeks

Post-surgical Weight Maintenance Intervention

Participants follow a conventional maintenance diet and continue physical activity and behavior counseling to maintain weight loss

12 weeks

Regular virtual counseling sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Multi-Component Weight Loss Intervention

Trial Overview The study tests a weight loss program before knee surgery, including a very low-calorie diet and behavior counseling, followed by a maintenance diet after surgery. Participants are randomly assigned to either this intervention or standard care without dietary advice.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Multi-component weight loss intervention

Group II: Standard Care Control Active Control 1 Intervention

Standard care

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

South Dakota State University

Collaborator

Trials

21

Recruited

10,100+

Published Research Related to This Trial

A dietitian-led preoperative very low calorie diet resulted in clinically significant weight loss (average of 7.1 kg) for 141 patients with obesity, which improved their American Society of Anesthesiologists scores and reduced estimated surgical risks.

The median risk of serious postoperative complications decreased from 4.8% to 3.9% and the risk of any complications from 6% to 5.1%, indicating that this dietary intervention may enhance safety for patients undergoing non-bariatric elective surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a dietitian-led very low calorie diet clinic on perioperative risk for patients with obesity awaiting elective, non-bariatric surgery: A retrospective cohort study. Griffin, SB., Palmer, MA., Strodl, E., et al.[2023]

A very low calorie diet (VLCD) program for 46 adults with obesity awaiting elective surgery resulted in significant weight loss (average -6.5 kg) compared to standard care, which showed no weight loss (+0.15 kg).

The VLCD program also led to a greater reduction in waist circumference and improved quality of life, all while maintaining muscle mass, indicating its feasibility and effectiveness as a pre-operative intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a very low calorie diet program into the pre-operative model of care for obese general elective surgery patients: Outcomes of a feasibility randomised control trial. Hollis, G., Franz, R., Bauer, J., et al.[2021]

An 8-week low-energy diet before total knee replacement led to an average weight loss of 10.7 kg in patients, which was maintained one year after surgery, indicating the feasibility and safety of preoperative weight loss interventions.

While both groups showed improvements in quality of life and knee function after surgery, there were no statistically significant differences between the diet and control groups, suggesting that while weight loss is beneficial, it may not directly translate to better functional outcomes compared to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight Loss Intervention Before Total Knee Replacement: A 12-Month Randomized Controlled Trial. Liljensøe, A., Laursen, JO., Bliddal, H., et al.[2022]

A systematic review of three studies involving 173 participants found that low-calorie diets before elective surgery led to a significant preoperative weight loss of about 6.67 kg compared to standard care.

However, the evidence suggests that these preoperative weight-loss diets do not significantly reduce postoperative complications or the length of hospital stay, indicating that while they may help with weight loss, they do not improve overall surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of weight-loss diets prior to elective surgery on postoperative outcomes in obesity: A systematic review and meta-analysis. Pavlovic, N., Boland, RA., Brady, B., et al.[2022]

Obesity significantly increases the risk of complications during and after total joint arthroplasty (TJA), including longer surgery times, higher hospitalization costs, and greater chances of infections and other serious issues.

Only 7% of patients denied TJA due to severe obesity were able to lose enough weight to qualify for surgery through lifestyle changes, highlighting the need for effective preoperative weight loss strategies, such as mobile health interventions, to improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity, preoperative weight loss, and telemedicine before total joint arthroplasty: a review. Seward, MW., Chen, AF.[2022]

A preoperative very low-calorie diet (VLCD) led to modest weight loss in patients preparing for bariatric surgery, with an average loss of 4.4% in those with a BMI ≥ 50 kg/m² and 3.8% in those with a BMI < 50 kg/m², indicating its effectiveness across different BMI groups.

The study found high patient compliance (75.5% for BMI < 50 kg/m² and 61.8% for BMI ≥ 50 kg/m²) and overall acceptability of the liquid diet, suggesting that patients were generally satisfied with the regimen despite some differences in hunger levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness, Compliance, and Acceptability of Preoperative Weight Loss with a Liquid Very Low-Calorie Diet Before Bariatric Surgery in Real Practice. Yolsuriyanwong, K., Thanavachirasin, K., Sasso, K., et al.[2020]

In a 3-year randomized trial involving 153 participants with knee osteoarthritis, both intermittent low-energy diet (LED) and daily meal replacements effectively maintained weight loss after an initial average loss of 10.5 kg, challenging the belief that long-term weight regain is inevitable.

The study found no significant difference in the number of knee replacements between the two groups, indicating that both dietary strategies are safe and do not adversely affect the need for surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term weight-loss maintenance in obese patients with knee osteoarthritis: a randomized trial. Christensen, P., Henriksen, M., Bartels, EM., et al.[2023]

In a study of 40 obese patients with chronic osteoarthritis, those who followed a hypocaloric diet using the Optisource® formula lost significantly more weight and fat mass compared to those receiving conventional dietary advice, with an average weight loss of -7.56 kg versus -5.18 kg after 3 months.

Both groups had similar outcomes regarding post-surgical complications and recovery times, indicating that the hypocaloric formula did not negatively impact surgical safety while providing better metabolic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a commercial hypocaloric diet in weight loss and post surgical morbidities in obese patients with chronic arthropathy, a randomized clinical trial. de Luis, DA., Izaola, O., García Alonso, M., et al.[2012]

A multi-component dietary weight loss program, including a ketogenic very low calorie diet and video consultations, was well-received by 24 patients with knee osteoarthritis, highlighting its ease of use and convenience as key factors for adherence.

Support from dietitians and the program's holistic approach, which included educational resources and exercise, were crucial for participants' success, leading to improved knee pain and function over the 6-month period.

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]

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. trials.arthritis.org trials.arthritis.org/trials/NCT05853497

A Multi-Component Weight Loss Intervention to Improve ... However, empirical evidence suggesting the effectiveness of pre-surgical weight loss on surgical and functional outcomes of TKA is extremely limited and is ...

2. trialstoday.org trialstoday.org/list/print/NCT05853497

A Multi-Component Weight Loss Intervention to Improve ... The intervention group will receive weekly 1-on-1 health coaching with a very-low calorie nutrition plan prior to total knee replacement and a ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10163509/

a qualitative study exploring experiences maintaining ... To explore experiences maintaining weight loss 6 months after completing a multicomponent weight loss programme for knee osteoarthritis.

4. acpjournals.org acpjournals.org/doi/abs/10.7326/ANNALS-25-00045

Efficacy of a Very-Low-Calorie Weight Loss Diet Plus ... Clinical trial evidence suggests that weight loss combined with exercise improves knee pain due to osteoarthritis, but whether weight loss ...

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

Comparison of weight loss interventions in overweight and ... PDE and DE interventions may offer the most effective approach for weight loss, potentially leading to significant improvements in pain and physical function.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31679465/

Weight Loss Intervention Before Total Knee Replacement The results suggest that it is feasible and safe to implement an intensive weight loss program shortly before total knee replacement.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT01469403

Weight Loss Intervention Before Total Knee Replacement The intervention program consists of 8 weeks of low-diet, using formula foods, and dietary counseling before surgery. When using formula foods the patients can ...