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

Virginia Commonwealth University (VCU)

Status: Enrolling

Conditions: Kidney Transplant; Complications; Obesity

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06688825

HM20029799

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Children, prisoners, pregnant women

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

Behavioral: Education regarding Weight loss

Biological: Blood draw

Behavioral: Lifestyle tools for weight loss