Actively Recruiting
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
Eligibility Criteria
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
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
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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