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NCT06640179: HEAL

Feasibility and Plausible Effectiveness of a Lifestyle Intervention in Kidney Transplant Recipients (HEAL)

Recruiting now NA Last updated 4 June 2025
What this trial tests

NA trial testing Standard medical care in Kidney Transplant in 60 participants. Currently enrolling.

Timeline
17 December 2024
Primary endpoint
1 October 2026
1 March 2027

Quick facts

Lead sponsorUniversity of Kansas Medical Center
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment60
Start date17 December 2024
Primary completion1 October 2026
Estimated completion1 March 2027
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Kansas Medical Center

Who can join

18 and older, any sex, with Kidney Transplant or Overweight or Obese Adults. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical trial is to learn whether if it is feasible to implement a study of patients receiving kidney transplantation, to learn if these patients will complete selective outcomes measurements, and to examine if a lifestyle intervention may assist with preventing weight gain compared to standard medical care. The main questions it aims to answer are: * Is it feasible to recruit and retain patients who have undergone kidney transplantation into a study to compare standard medical care to standard medical care plus a lifestyle intervention focused on prevention of weight gain? * Will participants engage in the interventions and be compliant to the components of the interventions? * Will there be any difference between the interventions between the interventions for the occurrence of adverse events specific to kidney transplantation? * Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on preventing weight gain compared to standard medical care alone? * Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on body composition compared to standard medical care alone? * Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on fasting glucose compared to standard medical care alone? * Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on fasting insulin compared to standard medical care alone? * Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on insulin sensitivity compared to standard medical care alone? * Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on physical function compared to standard medical care alone? * Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on health-related quality of life compared to standard medical care alone? * Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on changes in dietary intake compared to standard medical care alone? * Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on physical activity and sedentary behavior compared to standard medical care alone? Participants will: * Participants will continue with their standard medical care following kidney transplantation. * Participants only receiving standard medical care will also complete brief monitoring visits at week 6, 12, and 18. * Participants receiving the lifestyle intervention will attend weekly intervention sessions and will be recommended to modify their diet and physical activity behaviors in an effort to prevent weight gain. * Participants will complete outcome measurements as the start of the study and again after 6 months in the study. * After 6 months in the study, participants will also complete a brief intervention and answer other questions about their experience in the study.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Standard medical care

Trials testing the same drug.

Other recruiting trials for Kidney Transplant

Currently open trials in the same condition.

Other University of Kansas Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06640179.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing