Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06640179

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

Led by University of Kansas Medical Center · Updated on 2025-06-04

60

Participants Needed

1

Research Sites

114 weeks

Total Duration

On this page

Sponsors

U

University of Kansas Medical Center

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Received a kidney transplant within the prior 3 to 5 months from a deceased or living donor, with clearance from the transplant physician
  • Male or female of any race or ethnic group
  • 18 years of age or older
  • Body mass index (BMI) greater than 22 kg/m2 and weight within the limit of the body composition scan device (max 350 pounds)
  • Able to provide informed consent
  • Able to get clearance from the kidney transplant physician to participate in diet and physical activity interventions and outcome assessments
  • Able to walk for exercise
Not Eligible

You will not qualify if you...

  • Pregnant, breastfeeding, or planning pregnancy during the study; females of childbearing age not using double barrier contraception
  • History of bariatric surgery
  • Currently taking anti-obesity medications
  • Medical conditions or treatments affecting body weight such as diabetes, hyperthyroidism, uncontrolled hypothyroidism, chronic liver disease, cancer, gastrointestinal disorders
  • Current congestive heart failure, angina, uncontrolled arrhythmia, recent heart attack or procedures, or requiring chronic anticoagulation
  • Resting blood pressure systolic ≥160 mmHg or diastolic ≥100 mmHg or unstable treatment for hypertension
  • Eating disorders preventing diet or activity changes
  • Alcohol or substance abuse
  • Untreated or unstable psychological conditions including depression or bipolar disorder
  • Plans to relocate or commitments preventing attendance at sessions or assessments

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160

Actively Recruiting

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Research Team

J

John M. Jakicic, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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