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NCT Number: NCT06688825

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

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.

Recruiting

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Children, prisoners, pregnant women

Treatment and study plan

Education regarding Weight loss

Behavioral

Per American Association of Clinical Endocrinology (AACE) guidelines

Lifestyle tools for weight loss

Behavioral

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

Blood Draw

Biological

Per American Association of Clinical Endocrinology (AACE) guidelines

Primary outcomes

  1. Quality of Life-Lite survey

    Time frame: 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.

  2. Meal recall survey

    Time frame: 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

  3. PrevenT2 education T

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Dana Burns

CONTACT

[email protected]

804-828-5180

Evan Sisson

CONTACT

[email protected]

804-828-8076

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • American Society of Health-System Pharmacists Research and Education Foundation

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 14, 2024
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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