{"NCTID":"NCT06688825","clinicalTrial":{"derivedSection":{"conditionBrowseModule":{"ancestors":[{"id":"D050177","term":"Overweight"},{"id":"D044343","term":"Overnutrition"},{"id":"D009748","term":"Nutrition Disorders"},{"id":"D009750","term":"Nutritional and Metabolic Diseases"},{"id":"D001835","term":"Body Weight"},{"id":"D012816","term":"Signs and Symptoms"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"}],"meshes":[{"id":"D009765","term":"Obesity"}]},"interventionBrowseModule":{"ancestors":[{"id":"D013048","term":"Specimen Handling"},{"id":"D019411","term":"Clinical Laboratory Techniques"},{"id":"D019937","term":"Diagnostic Techniques and Procedures"},{"id":"D003933","term":"Diagnosis"},{"id":"D011677","term":"Punctures"},{"id":"D013514","term":"Surgical Procedures, Operative"},{"id":"D008919","term":"Investigative Techniques"}],"meshes":[{"id":"D001800","term":"Blood Specimen Collection"}]},"miscInfoModule":{"versionHolder":"2026-03-13"}},"hasResults":false,"protocolSection":{"armsInterventionsModule":{"armGroups":[{"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.","interventionNames":["Behavioral: Education regarding Weight loss","Behavioral: Lifestyle tools for weight loss","Biological: Blood draw"],"label":"Subjects on the waiting list for kidney transplant at VCUHS with BMI greater than 35 kg/m2.","type":"EXPERIMENTAL"}],"interventions":[{"armGroupLabels":["Subjects on the waiting list for kidney transplant at VCUHS with BMI greater than 35 kg/m2."],"description":"Per American Association of Clinical Endocrinology (AACE) guidelines","name":"Education regarding Weight loss","type":"BEHAVIORAL"},{"armGroupLabels":["Subjects on the waiting list for kidney transplant at VCUHS with BMI greater than 35 kg/m2."],"description":"Calorie App, Continuous GlucosWe Monitor (CGM), Weight Scale, Food Scale","name":"Lifestyle tools for weight loss","type":"BEHAVIORAL"},{"armGroupLabels":["Subjects on the waiting list for kidney transplant at VCUHS with BMI greater than 35 kg/m2."],"description":"Per American Association of Clinical Endocrinology (AACE) guidelines","name":"Blood draw","type":"BIOLOGICAL"}]},"conditionsModule":{"conditions":["Kidney Transplant; Complications","Obesity"]},"contactsLocationsModule":{"centralContacts":[{"email":"emsisson@vcu.edu","name":"Evan Sisson","phone":"804-828-8076","role":"CONTACT"},{"email":"dburns@vcu.edu","name":"Dana Burns","phone":"804-828-5180","role":"CONTACT"}],"locations":[{"city":"Richmond","contacts":[{"email":"emsisson@vcu.edu","name":"Evan Sisson","phone":"804-828-8076","role":"CONTACT"},{"email":"dburns@vcu.edu","name":"Dana Burns","phone":"804-828-5180","role":"CONTACT"}],"country":"United States","facility":"Virginia Commonwealth University","geoPoint":{"lat":37.55376,"lon":-77.46026},"state":"Virginia","status":"RECRUITING","zip":"23298"}],"overallOfficials":[{"affiliation":"Virginia Commonwealth University","name":"Evan Sisson","role":"PRINCIPAL_INVESTIGATOR"}]},"descriptionModule":{"briefSummary":"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.","detailedDescription":"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.\nObesity, hypertension, and ESRD disproportionately affect the Black community, and Black patients have been historically disadvantaged by race-inclusive calculations that overestimated their kidney function.\nEffective 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.\nThey also required transplant programs to identify Black candidates who may have been wrongly denied qualification"},"designModule":{"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","interventionModelDescription":"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.","maskingInfo":{"masking":"NONE","maskingDescription":"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."},"primaryPurpose":"TREATMENT"},"enrollmentInfo":{"count":30,"type":"ESTIMATED"},"phases":["NA"],"studyType":"INTERVENTIONAL"},"eligibilityModule":{"eligibilityCriteria":"

Inclusion Criteria:

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

Exclusion Criteria:

Children, prisoners, pregnant women

","healthyVolunteers":false,"minimumAge":"18 Years","sex":"ALL","stdAges":["ADULT","OLDER_ADULT"]},"identificationModule":{"briefTitle":"Feasibility Study for the Comprehensive Overweight/Obesity Management Pre-Kidney Transplant (COMPKT) Program","nctId":"NCT06688825","officialTitle":"Feasibility Study for the Comprehensive Overweight/Obesity Management Pre-Kidney Transplant (COMPKT) Program","orgStudyIdInfo":{"id":"HM20029799"},"organization":{"class":"OTHER","fullName":"Virginia Commonwealth University"}},"outcomesModule":{"primaryOutcomes":[{"description":"

Impact of Weight on Quality of Life-Lite (IWQOL-Lite©) Screening.\nIWQOL-Lite© is a validated, 31-item, self-report measure of obesity-specific quality of life in adults.\nThe 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.

","measure":"Quality of Life-Lite survey","timeFrame":"Only completed at baseline and week 40"},{"description":"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.\nThe goal is to gather detailed information about a person's diet, including portion sizes, cooking methods, and time of consumption.\nThis information can be used to identify dietary patterns, assess nutrient intake, and develop nutrition recommendations","measure":"Meal recall survey","timeFrame":"completed at weeks 1, 4, 8, 12, 20 and 28"},{"description":"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.\nThe PreventT2 program can help people with prediabetes cut their risk of developing type 2 diabetes in half.\nT","measure":"PrevenT2 education T","timeFrame":"Weekly for weeks 1-12, then monthly on weeks 16, 24, 28, 32 and 36"}]},"oversightModule":{"isFdaRegulatedDevice":false,"isFdaRegulatedDrug":false,"isUsExport":false,"oversightHasDmc":false},"sponsorCollaboratorsModule":{"collaborators":[{"class":"OTHER","name":"American Society of Health-System Pharmacists Research and Education Foundation"}],"leadSponsor":{"class":"OTHER","name":"Virginia Commonwealth University"},"responsibleParty":{"type":"SPONSOR"}},"statusModule":{"completionDateStruct":{"date":"2026-03","type":"ESTIMATED"},"expandedAccessInfo":{"hasExpandedAccess":false},"lastUpdatePostDateStruct":{"date":"2025-11-19","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-11-17","overallStatus":"RECRUITING","primaryCompletionDateStruct":{"date":"2026-03","type":"ESTIMATED"},"startDateStruct":{"date":"2024-09-16","type":"ACTUAL"},"statusVerifiedDate":"2025-11","studyFirstPostDateStruct":{"date":"2024-11-14","type":"ACTUAL"},"studyFirstSubmitDate":"2024-10-29","studyFirstSubmitQcDate":"2024-11-12"}}},"labeledClinicalTrialsCriteria":{"data":{"criteriaTree":{"id":"root","items":[{"id":"inclusion","items":[{"data":{"age":18,"operator":">=","type":"ageRule"},"hash":"[[\"age:18\",\"operator:>=\",\"type:ageRule\"]]","id":"rule_3925dfb6_7c0e_4895_b434_aea5a07147d4","type":"rule"}],"operator":"AND","type":"group"},{"id":"exclusion","items":[],"operator":"OR","type":"group"}],"type":"group"},"disease":{"_type":"DocumentReference","path":"diseases/E7FvorVuNJjGzy9wH7fy"},"hasManualMappings":false,"nctId":"NCT06688825","sourceBatch":{"_type":"DocumentReference","path":"apps/clinicalTrials/clinicalTrialsBatches/batch_68a836a93f24819087210dd6c5f89ba0"},"status":"RECRUITING","updatedAt":{"_type":"Date","value":"Mon Sep 29 2025 07:50:29 GMT+0000 (Coordinated Universal Time)"},"version":"v3.1"},"included":{},"ref":{"_type":"DocumentReference","path":"apps/clinicalTrials/clinicalTrialsTrees/NCT06688825-E7FvorVuNJjGzy9wH7fy"},"snapshot":{"exists":true,"id":"NCT06688825-E7FvorVuNJjGzy9wH7fy","ref":{"_type":"DocumentReference","path":"apps/clinicalTrials/clinicalTrialsTrees/NCT06688825-E7FvorVuNJjGzy9wH7fy"}}}}

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