Feasibility Study for the Comprehensive Overweight/Obesity Management Pre-Kidney Transplant (COMPKT) Program

NCT06688825 | Recruiting

• 1 other identifier: HM20029799
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplant; Complications; Obesity

Outcome Measures

Primary Outcomes (3)

• 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.

  Only completed at baseline and week 40

• 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

  completed at weeks 1, 4, 8, 12, 20 and 28

• 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

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

Study Arms (1)

Subjects on the waiting list for kidney transplant at VCUHS with BMI greater than 35 kg/m2.

EXPERIMENTAL

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.

Behavioral: Education regarding Weight loss; Behavioral: Lifestyle tools for weight loss; Biological: Blood draw

Interventions

Education regarding Weight loss BEHAVIORAL

Per American Association of Clinical Endocrinology (AACE) guidelines

Subjects on the waiting list for kidney transplant at VCUHS with BMI greater than 35 kg/m2.

Lifestyle tools for weight loss BEHAVIORAL

Calorie App, Continuous GlucosWe Monitor (CGM), Weight Scale, Food Scale

Subjects on the waiting list for kidney transplant at VCUHS with BMI greater than 35 kg/m2.

Blood draw BIOLOGICAL

Per American Association of Clinical Endocrinology (AACE) guidelines

Subjects on the waiting list for kidney transplant at VCUHS with BMI greater than 35 kg/m2.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• on the waiting list for kidney transplant at VCUHS
• BMI greater than 35 kg/m2

You may not qualify if:

• Children, prisoners, pregnant women

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• American Society of Health-System Pharmacists Research and Education Foundation: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Evan Sisson

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Evan Sisson

CONTACT

804-828-8076; emsisson@vcu.edu

Dana Burns

CONTACT

804-828-5180; dburns@vcu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: November 14, 2024
• Study Start: September 16, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

US (1)