Weight Loss Program for Obesity

Overseen By Dana Burns

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Disqualifiers: Children, prisoners, pregnant women

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

Compensation: Varies

Number of Visits: 1

Duration: 40 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This project will be a single-arm feasibility study, with a treatment intervention that includes three interrelated components: (1) patient education using a proven weight loss curriculum, and (2) technology tools for making healthy lifestyle choices.

Do I need to stop my current medications for the trial?

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

What data supports the effectiveness of this treatment for weight loss in obesity?

There is limited evidence for the effectiveness of educational interventions for kidney transplant recipients, and more research is needed to develop effective lifestyle interventions for obese children or adolescents with diabetes or kidney disease. However, a behavioral intervention was tested for its effect on BMI and physical activity after renal transplantation, suggesting some potential for lifestyle changes to help manage weight. ^{1 2 3 4 5}

Is the weight loss program for obesity generally safe for humans?

The weight loss program, which includes meal replacements, behavioral education, and physical activity, has been shown to improve kidney function and reduce the need for medications in people with chronic kidney disease, indicating it is generally safe for humans. ^{3 5 6 7 8}

How is the Weight Loss Program for Obesity treatment different from other treatments for obesity?

This weight loss program is unique because it focuses on education and lifestyle tools specifically tailored for individuals with chronic kidney disease (CKD) who are candidates for kidney transplantation. It emphasizes a conservative, non-surgical approach with a focus on personalized dietary changes and multidisciplinary support, which is not commonly available in standard obesity treatments. ^{4 5 7 9 10}

Research Team

Evan Sisson

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

This trial is for individuals with obesity who are preparing for a kidney transplant. Participants should be interested in weight loss and willing to use educational materials and technology tools designed to help them make healthier lifestyle choices.

Inclusion Criteria

On the waiting list for kidney transplant at VCUHS

BMI greater than 35 kg/m2

Exclusion Criteria

Pregnant women

Prisoners

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a weight loss treatment intervention including medications, patient education, and technology tools for healthy lifestyle choices

40 weeks

Weekly visits for weeks 1-12, then monthly visits on weeks 16, 24, 28, 32, and 36

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Education regarding Weight loss
• Lifestyle tools for weight loss

Trial Overview The study tests a program that combines patient education on weight loss with the use of tech tools to support healthy living. It's a single-arm feasibility study, meaning all participants receive the same intervention without comparison groups.

Participant Groups

Group I: Subjects on the waiting list for kidney transplant at VCUHS with BMI greater than 35 kg/m2. Experimental Treatment 3 Interventions

This project will be a single-arm feasibility study, with a treatment intervention that includes three interrelated components: (1) the use of medications for weight loss, (2) patient education using a proven weight loss curriculum, and (3) technology tools for making healthy lifestyle choices.

Education regarding Weight loss is already approved in United States, European Union for the following indications:

Approved in United States as Weight Loss Education for:

• Pre-kidney transplant weight management
• Obesity management

Approved in European Union as Weight Management Education for:

• Pre-kidney transplant weight management
• Obesity management

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

American Society of Health-System Pharmacists Research and Education Foundation

Collaborator

Trials

5

Recruited

370+

Findings from Research

An 8-month behavioral intervention aimed at preventing weight gain in kidney transplant recipients showed high patient satisfaction but did not result in significantly different weight changes compared to usual care, with both groups experiencing minimal weight gain.

Both the intervention and control groups maintained similar levels of physical activity, averaging around 10,800 steps per day, indicating that the behavioral intervention did not enhance physical activity levels beyond standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of a Behavioral Versus an Educational Weight Management Intervention After Renal Transplantation: A Randomized Controlled Trial. Schmid-Mohler, G., Zala, P., Graf, N., et al.[2022]

A systematic review of nine trials, including three randomized controlled trials, found limited evidence supporting the effectiveness of patient education programs for kidney transplant recipients, primarily due to moderate to high risk of bias in the studies.

The most promising educational interventions identified were video-assisted teaching before discharge and monthly pharmaceutical counseling, suggesting that tailored educational approaches may improve patient outcomes post-transplant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Limited evidence for the effectiveness of educational interventions for renal transplant recipients. Results from a systematic review of controlled clinical trials. Urstad, KH., Wahl, AK., Andersen, MH., et al.[2019]

The ExeRTiOn online resource, designed to help prevent weight gain after kidney transplantation, was positively received by both patients and healthcare professionals, highlighting its role in filling a guidance gap and emphasizing the importance of goal setting and progress monitoring.

Feedback from participants indicated areas for improvement in the resource, which will be used to refine ExeRTiOn before it undergoes a randomized controlled feasibility trial, ensuring it meets the needs of kidney transplant recipients effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability and experience testing to refine an online intervention to prevent weight gain in new kidney transplant recipients. Castle, EM., Greenwood, J., Chilcot, J., et al.[2022]

The review found that there is a lack of effective evidence-based lifestyle interventions for obese children and adolescents with diabetes, and no effective interventions for those with kidney diseases, highlighting a significant gap in treatment options.

The research emphasizes the urgent need for further studies to develop targeted interventions that can promote lifestyle changes in these vulnerable populations, as current options are insufficient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle change interventions for children and adolescents with diabetes or kidney disease. Sanderson, LL.[2013]

In a study of 80 morbidly obese kidney transplant candidates with a mean follow-up of 24 months, 26.3% achieved successful weight loss to a BMI under 35 kg/m2, particularly among women and those closer to the target.

The study highlighted that only 14.6% of patients had prior nutritional counseling, suggesting that tailored nutritional interventions could improve weight loss outcomes for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conservative Management of Obesity in Kidney Transplant Candidates. Hajjar, R., Marcotte, C., Chan, G.[2022]

In a study of 71 adults participating in a 12-week weight management program, significant weight loss was associated with improved kidney function, as indicated by a correlation between weight loss and increased glomerular filtration rate (GFR).

Most participants (76.1%) improved in their chronic kidney disease (CKD) stage, and there were notable improvements in blood sugar levels, blood pressure, and lipid profiles, leading to a reduction in medications for hypertension (61.8%) and diabetes (83.3%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Community-Based Weight Loss Program on Renal Function. Schwasinger-Schmidt, TE., Elhomsy, G., Paull-Forney, BG.[2020]

The study identified 40 weight management programs across North America specifically for individuals with chronic kidney disease (CKD), including commercial, community-based, and medically supervised options, with three programs tailored specifically for CKD.

Common barriers to accessing these programs included high food costs, lack of support, and time commitments, while successful programs were characterized by being patient-centered and evidence-based, highlighting the need for future research to engage CKD patients in program development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

North American Weight Management Programs for People Living With Chronic Kidney Disease: An Environmental Scan. Hamadi, A., Clemens, KK., Ernst, J., et al.[2023]

The workshop highlighted that obesity significantly contributes to chronic kidney disease (CKD) and that effective obesity treatments, such as lifestyle changes, medications, and metabolic surgery, can improve outcomes for CKD patients.

Experts from various fields collaborated to create strategies for better engagement in obesity management among patients and healthcare providers, aiming to develop a comprehensive approach to tackle obesity in individuals with CKD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obstacles and Opportunities in Managing Coexisting Obesity and CKD: Report of a Scientific Workshop Cosponsored by the National Kidney Foundation and The Obesity Society. Friedman, AN., Schauer, PR., Beddhu, S., et al.[2023]

A 71-year-old man with advanced chronic kidney disease and obesity successfully lost 16 kg in 2 months through a qualitative, ad libitum coach-assisted diet, allowing him to meet the weight criteria for kidney transplant wait-listing.

The patient maintained a stable weight and kidney function over 35 months, demonstrating that with proper multidisciplinary support, individuals with chronic kidney disease can effectively manage their weight and improve their eligibility for transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight Loss in Advanced Chronic Kidney Disease: Should We Consider Individualised, Qualitative, ad Libitum Diets? A Narrative Review and Case Study. Capizzi, I., Teta, L., Vigotti, FN., et al.[2018]

A structured weight management program (WMP) led to significant weight loss in 135 obese patients with chronic kidney disease (CKD) over 24 months, indicating its effectiveness for this population.

Higher compliance with the WMP was associated with greater weight loss and a reduction in systolic blood pressure, suggesting that adherence to the program is crucial for achieving health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compliance with a structured weight loss program is associated with reduced systolic blood pressure in obese patients with chronic kidney disease. MacLaughlin, HL., Sarafidis, PA., Greenwood, SA., et al.[2021]

References

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

Comparison of a Behavioral Versus an Educational Weight Management Intervention After Renal Transplantation: A Randomized Controlled Trial. [2022]

2. Ireland pubmed.ncbi.nlm.nih.gov

Limited evidence for the effectiveness of educational interventions for renal transplant recipients. Results from a systematic review of controlled clinical trials. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Usability and experience testing to refine an online intervention to prevent weight gain in new kidney transplant recipients. [2022]

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

Lifestyle change interventions for children and adolescents with diabetes or kidney disease. [2013]

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

Conservative Management of Obesity in Kidney Transplant Candidates. [2022]

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

Impact of a Community-Based Weight Loss Program on Renal Function. [2020]

7. England pubmed.ncbi.nlm.nih.gov

North American Weight Management Programs for People Living With Chronic Kidney Disease: An Environmental Scan. [2023]

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

Obstacles and Opportunities in Managing Coexisting Obesity and CKD: Report of a Scientific Workshop Cosponsored by the National Kidney Foundation and The Obesity Society. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Weight Loss in Advanced Chronic Kidney Disease: Should We Consider Individualised, Qualitative, ad Libitum Diets? A Narrative Review and Case Study. [2018]

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

Compliance with a structured weight loss program is associated with reduced systolic blood pressure in obese patients with chronic kidney disease. [2021]