Kidney Transplant; ComplicationsNCT06688825
Feasibility Study for the Comprehensive Overweight/Obesity Management Pre-Kidney Transplant (COMPKT) Program
A study testing Education regarding Weight loss, Lifestyle tools for weight loss and Blood draw in people with Kidney Transplant; Complications and Obesity, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant; Complications, Obesity
- What is being tested?
- Education regarding Weight loss, Lifestyle tools for weight loss and Blood draw
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2024to 20 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- on the waiting list for kidney transplant at VCUHS
- BMI greater than 35 kg/m2
Who cannot join
- Children, prisoners, pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
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.
Read the 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
- Conditions
- Kidney Transplant; Complications, Obesity
- Being tested
- Education regarding Weight loss, Lifestyle tools for weight loss, Blood draw
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education regarding Weight lossBehavioural
Per American Association of Clinical Endocrinology (AACE) guidelines
Lifestyle tools for weight lossBehavioural
Calorie App, Continuous GlucosWe Monitor (CGM), Weight Scale, Food Scale
Blood drawBiological
Per American Association of Clinical Endocrinology (AACE) guidelines
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Education regarding Weight loss; Behavioral: Lifestyle tools for weight loss; Biological: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: Weekly for weeks 1-12, then monthly on weeks 16, 24, 28, 32 and 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start16 Sep 2024
- Primary completion20 Oct 2025
- Study completion20 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- American Society of Health-System Pharmacists Research and Education Foundation
- Responsible party
- Sponsor
- Investigators
- Evan Sisson, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688825
- Sponsor's protocol ID
- HM20029799
- Status last verified
- Aug 2026
- First submitted
- 29 Oct 2024
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study for the Comprehensive Overweight/Obesity Management Pre-Kidney Transplant (COMPKT) Program
- ClinicalTrials.gov ID
- NCT06688825
- Acronym / sponsor ID
- HM20029799
- Conditions
- Kidney Transplant; Complications, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- American Society of Health-System Pharmacists Research and Education Foundation
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Subjects on the waiting list for kidney transplant at VCUHS with BMI greater than 35 kg/m2. | Experimental | Behavioral: Education regarding Weight loss, Behavioral: Lifestyle tools for weight loss, Biological: Blood drawThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- on the waiting list for kidney transplant at VCUHS
- BMI greater than 35 kg/m2
Key exclusion criteria (1 listed)
- Children, prisoners, pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education regarding Weight lossPer American Association of Clinical Endocrinology (AACE) guidelines | Behavioural | Subjects on the waiting list for kidney transplant at VCUHS with BMI greater than 35 kg/m2. |
| Lifestyle tools for weight lossCalorie App, Continuous GlucosWe Monitor (CGM), Weight Scale, Food Scale | Behavioural | Subjects on the waiting list for kidney transplant at VCUHS with BMI greater than 35 kg/m2. |
| Blood drawPer American Association of Clinical Endocrinology (AACE) guidelines | Biological | Subjects on the waiting list for kidney transplant at VCUHS with BMI greater than 35 kg/m2. |
Primary outcome
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.
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evan Sisson principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education regarding Weight loss, Lifestyle tools for weight loss and Blood draw in people with Kidney Transplant; Complications and Obesity, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life-Lite survey (time frame: Only completed at baseline and week 40). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.