Feasibility Study for the Comprehensive Overweight/Obesity Management Pre-Kidney Transplant (COMPKT) Program
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVirginia Commonwealth University
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
on the waiting list for kidney transplant at VCUHS
BMI greater than 35 kg/m2
Disqualifiers
Children, prisoners, pregnant women
Trial design
Design model
Single group
Treatments tested in this trial
Education regarding Weight loss
BehavioralPer American Association of Clinical Endocrinology (AACE) guidelines
Lifestyle tools for weight loss
BehavioralCalorie App, Continuous GlucosWe Monitor (CGM), Weight Scale, Food Scale
Blood draw
Biological/VaccinePer American Association of Clinical Endocrinology (AACE) guidelines
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Subjects on the waiting list for kidney transplant at VCUHS with BMI greater than 35 kg/m2.Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Quality of Life-Lite survey
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.
Time frame
Only completed at baseline and week 402
Meal recall survey
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
Time frame
completed at weeks 1, 4, 8, 12, 20 and 283
PrevenT2 education T
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
Time frame
Weekly for weeks 1-12, then monthly on weeks 16, 24, 28, 32 and 36Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Virginia Commonwealth University
Lead sponsor
American Society of Health-System Pharmacists Research and Education Foundation
Collaborator
Source ClinicalTrials.gov