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

Part of paid clinical trials in Richmond, Virginia.

Sponsor
Virginia Commonwealth University
Study ID
NCT06688825
Status
Recruiting

Conditions

  • Kidney Transplant; Complications
  • Obesity

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study 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.

Key Dates

Start date
Sep 16, 2024
Status verified
Jun 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Quality of Life-Lite survey [ Time Frame: Only completed at baseline and week 40 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Virginia Commonwealth UniversityRichmondVirginia23298
Evan Sisson
804-828-8076
Dana Burns
804-828-5180

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