Kidney Transplant; Complications, Obesity
Conditions
Brief summary
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.
Detailed description
To optimize care for overweight/obese patients who are awaiting kidney transplants by implementing a referral process and a multi-pronged, team-based nurse/pharmacist/dietitian weight loss treatment intervention to help these patients achieve transplant criteria. Obesity, hypertension, and ESRD disproportionately affect the Black community, and Black patients have been historically disadvantaged by race-inclusive calculations that overestimated their kidney function. Effective January 5, 2023, the Organ Procurement and Transplantation Network Board of Directors requires use of a race-neutral estimated glomerular filtration rate (eGFR) to qualify candidates for kidney transplant. They also required transplant programs to identify Black candidates who may have been wrongly denied qualification
Interventions
BEHAVIORALEducation regarding Weight loss
Per American Association of Clinical Endocrinology (AACE) guidelines
BEHAVIORALLifestyle tools for weight loss
Calorie App, Continuous GlucosWe Monitor (CGM), Weight Scale, Food Scale
BIOLOGICALBlood draw
Per American Association of Clinical Endocrinology (AACE) guidelines
Sponsors
Virginia Commonwealth University
American Society of Health-System Pharmacists Research and Education Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* on the waiting list for kidney transplant at VCUHS * BMI greater than 35 kg/m2
Exclusion criteria
* Children, prisoners, pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life-Lite survey | Only completed at baseline and week 40 | Impact of Weight on Quality of Life-Lite (IWQOL-Lite©) Screening. IWQOL-Lite© is a validated, 31-item, self-report measure of obesity-specific quality of life in adults. The scale structure of the IWQOL-Lite has been verified with confirmatory factor analysis. In addition to a total score, there are scores on five domains: Physical function (11 items) Self-esteem (7 items) Sexual life (4 items) Public distress (5 items) Work (4 items) Scores range from 0 to 100, with 100 representing the best quality of life. |
| Meal recall survey | completed at weeks 1, 4, 8, 12, 20 and 28 | A meal recall survey, also known as a 24-hour dietary recall, is a structured interview that asks a person to recall what they ate and drank in the previous 24 hours. The goal is to gather detailed information about a person's diet, including portion sizes, cooking methods, and time of consumption. This information can be used to identify dietary patterns, assess nutrient intake, and develop nutrition recommendations |
| PrevenT2 education T | Weekly for weeks 1-12, then monthly on weeks 16, 24, 28, 32 and 36 | A program from the National Diabetes Prevention Program that helps people with prediabetes to change their risk of developing type 2 diabetes using a CDC-approved curriculum. The PreventT2 program can help people with prediabetes cut their risk of developing type 2 diabetes in half. T |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREvan Sisson
Virginia Commonwealth University
Outcome results
None listed