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.
12345Is 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.
35678How 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.
457910Eligibility 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
I am under 18 years old.
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Subjects on the waiting list for kidney transplant at VCUHS with BMI greater than 35 kg/m2.Experimental Treatment3 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Virginia Commonwealth UniversityRichmond, VA
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Who Is Running the Clinical Trial?
Virginia Commonwealth UniversityLead Sponsor
American Society of Health-System Pharmacists Research and Education FoundationCollaborator
References
Comparison of a Behavioral Versus an Educational Weight Management Intervention After Renal Transplantation: A Randomized Controlled Trial. [2022]In the first year following renal transplantation, preventing weight gain to minimize overweight or obesity is particularly important. The aim of this study is to test the effect of an 8-month behavioral intervention BMI and physical activity.
Limited evidence for the effectiveness of educational interventions for renal transplant recipients. Results from a systematic review of controlled clinical trials. [2019]To describe the content and evaluate the effectiveness of patient education programs for renal recipients.
Usability and experience testing to refine an online intervention to prevent weight gain in new kidney transplant recipients. [2022]Weight gain in the first year following kidney transplantation increases the risk of adverse health outcomes. Currently, there is no recognized intervention available to prevent weight gain after kidney transplantation. An online kidney transplant-specific resource, entitled Exercise in Renal Transplant Online (ExeRTiOn), has been co-created by a multi-professional team, including patients, to assist with weight prevention. This study aimed to evaluate patient and health care professional usability and experience of the ExeRTiOn online resource.
Lifestyle change interventions for children and adolescents with diabetes or kidney disease. [2013]The purpose of this research letter is to report on the availability of evidence-based interventions for promoting lifestyle change in children and adolescents with diabetes or kidney disease. References for this review were obtained using several electronic databases, including Ebsco Host, PsychInfo, Medline, and CINAHL. Search topics included transplant adherence, diabetes adherence, kidney adherence, obesity and transplant, kidney disease, transplant noncompliance, renal failure, renal disease, chronic kidney failure, end-stage renal disease, obesity and diabetes, overweight and kidney disease, overweight and diabetes, overweight, treatment interventions and overweight, treatment interventions for obesity, children and obesity, growth chart, diabetes intervention, kidney disease intervention, obesity intervention, obesity and transplantation, obesity transplant intervention, motivational interviewing, physical activity level, physical activity, exercise intervention, body mass index measurement, body fat percentage, psychosocial issues of kidney disease, psychosocial issues of transplant, and coping with kidney disease. Search results included English language only and between the years 2000 and 2009. Very few lifestyle interventions have been shown to be effective for obese children or adolescents with diabetes and none for obese children and adolescents with kidney diseases. More research is needed to develop effective interventions for this vulnerable population.
Conservative Management of Obesity in Kidney Transplant Candidates. [2022]Obesity is prevalent in patients with chronic kidney disease and is associated with increased complications after kidney transplantation (KT). A body mass index limit is used in most transplant programs, though few studies have focused on conservative weight loss in KT candidates. The objective of this retrospective study is to evaluate the efficacy of a basic conservative weight management program in morbidly obese KT candidates and to perform a comprehensive nutritional evaluation.
Impact of a Community-Based Weight Loss Program on Renal Function. [2020]Introduction Obesity is associated with increased morbidity and mortality and is an independent risk factor for the development and progression of chronic kidney disease (CKD). This study investigated the effect of a community-based, lifestyle-focused, weight-loss intervention on renal function among participants at baseline following 12 weeks of therapy.  Methods A retrospective analysis of adults enrolled in a weight management program from 2009 to 2014 was conducted. Participants consumed at least 800 kilocalories per day in meal replacements, attended weekly behavioral education classes, and expended approximately 300 kilocalories per day in physical activity. The primary outcome was the association of weight loss and changes in glomerular filtration rate (GFR). Secondary outcomes included changes in blood sugar levels, lipid parameters, blood pressure, and the use of medication for hypertension and diabetes mellitus.  Results Of the 71 participants, 63.4% were female, the average weight was 289 pounds, the average body mass index (BMI) of 53, and baseline GFR 47 ml/min/1.73m2. Following 12 weeks of the intervention, 76.1% of participants improved in CKD stage, 22.4% remained within the same stage, and 1.5% progressed to a higher stage (3A to 3B). Analysis revealed a correlation between weight loss and improved GFR (p=0.0006). Improvements were noted in blood sugar levels, blood pressure, and lipids (p<0.05). Medications were reduced in 61.8% of participants for hypertension and 83.3% for diabetes. Conclusions A significant correlation was observed between weight loss and improved renal function, with most participants improving in CKD stage. Participants also improved in markers of chronic disease and required fewer medications. When controlling for both diabetes and hypertension, the effect of improved renal function persisted.
North American Weight Management Programs for People Living With Chronic Kidney Disease: An Environmental Scan. [2023]The availability and accessibility of patient-centered weight management programs is critical to mitigate the increasing prevalence of obesity in people living with chronic kidney disease (CKD). Little is known about the availability of contemporary programs that can safely and effectively support individuals living with obesity and CKD across North America.
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]The National Kidney Foundation (NKF) and The Obesity Society (TOS) cosponsored a multispecialty international workshop in April 2021 to advance the understanding and management of obesity in adults with chronic kidney disease (CKD). The underlying rationale for the workshop was the accumulating evidence that obesity is a major contributor to CKD and adverse outcomes in individuals with CKD, and that effective treatment of obesity, including lifestyle intervention, weight loss medications, and metabolic surgery, can have beneficial effects. The attendees included a range of experts in the areas of kidney disease, obesity medicine, endocrinology, diabetes, bariatric/metabolic surgery, endoscopy, transplant surgery, and nutrition, as well as patients with obesity and CKD. The group identified strategies to increase patient and provider engagement in obesity management, outlined a collaborative action plan to engage nephrologists and obesity medicine experts in obesity management, and identified research opportunities to address gaps in knowledge about the interaction between obesity and kidney disease. The workshop's conclusions help lay the groundwork for development of an effective, scientifically based, and multidisciplinary approach to the management of obesity in people with CKD.
Weight Loss in Advanced Chronic Kidney Disease: Should We Consider Individualised, Qualitative, ad Libitum Diets? A Narrative Review and Case Study. [2018]In advanced chronic kidney disease, obesity may bring a survival advantage, but many transplant centres demand weight loss before wait-listing for kidney graft. The case here described regards a 71-year-old man, with obesity-related glomerulopathy; referral data were: weight 110 kg, Body Mass Index (BMI) 37 kg/m², serum creatinine (sCr) 5 mg/dL, estimated glomerular filtration rate (eGFR) 23 mL/min, blood urea nitrogen (BUN) 75 mg/dL, proteinuria 2.3 g/day. A moderately restricted, low-protein diet allowed reduction in BUN (45-55 mg/dL) and good metabolic and kidney function stability, with a weight increase of 6 kg. Therefore, he asked to be enrolled in a weight-loss program to be wait-listed (the two nearest transplant centres required a BMI below 30 or 35 kg/m²). Since previous low-calorie diets were not successful and he was against a surgical approach, we chose a qualitative, ad libitum coach-assisted diet, freely available in our unit. In the first phase, the diet is dissociated; he lost 16 kg in 2 months, without need for dialysis. In the second maintenance phase, in which foods are progressively combined, he lost 4 kg in 5 months, allowing wait-listing. Dialysis started one year later, and was followed by weight gain of about 5 kg. He resumed the maintenance diet, and his current body weight, 35 months after the start of the diet, is 94 kg, with a BMI of 31.7 kg/m², without clinical or biochemical signs of malnutrition. This case suggests that our patients can benefit from the same options available to non-CKD (chronic kidney disease) individuals, provided that strict multidisciplinary surveillance is assured.
Compliance with a structured weight loss program is associated with reduced systolic blood pressure in obese patients with chronic kidney disease. [2021]The effectiveness of lifestyle-based weight loss programs in obese patients with chronic disease has not been widely studied. This study examined the effectiveness of a weight management program (WMP), and sought to determine factors associated with successful weight loss in obese patients with chronic kidney disease (CKD).