Lifestyle program to prevent weight gain after kidney transplant
Tests a lifestyle program with standard care in adults after kidney transplant.
Key facts
- Who runs it
- University of Kansas Medical Center
- Where
- Kansas City, United StatesSee the site
- Trial code
- Registry title
- Feasibility and Plausible Effectiveness of a Lifestyle Intervention in Kidney Transplant Recipients (HEAL)
- Status
- Recruiting
- People taking part
- 60 people, planned
- Started
- 17 Dec 2024
- Expected to end
- 1 Mar 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Standard medical care
- Monitoring Contacts
- Behavioral Sessions
- Diet
- Physical Activity
- Record updated
- 2 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who had a kidney transplant 3-5 months ago and have a body mass index above 22. It tests a lifestyle program to prevent weight gain.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Kidney transplant received within the prior 3-5 months, from a deceased or living donor.
- Earlier treatment
- Must not have had bariatric surgery and must not be on an anti-obesity medication. The kidney transplant doctor must clear the person for the diet and exercise parts.
- Biomarker or test result
- Body mass index (BMI) above 22 kg/m2. The weight must not be over 350 pounds (159 kg), the limit of the body scan machine.
Main reasons for not taking part
- Pregnant, breastfeeding or planning a pregnancy during the study
- Medical conditions that can affect body weight, such as diabetes, thyroid disease, chronic liver disease or cancer
- Heart problems such as heart failure, angina or a prior heart attack
- Resting blood pressure of 160 mmHg or higher (systolic) or 100 mmHg or higher (diastolic), or blood pressure not stable on treatment
- Eating disorders, alcohol or substance abuse
This trial only enrols participants who have had an organ transplant. The registry sentence this rests on: Receiving a kidney transplant within the prior 3-5 months, with the transplant received from a deceased donor or living donor.
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- Receiving a kidney transplant within the prior 3-5 months, with the transplant received from a deceased donor or living donor. NOTE: The patient will be eligible for randomization at 3 months following the kidney transplant, or at a subsequent time once clearance from the kidney transplant physician is given, provided that the time does not exceed 5 months following the kidney transplant
- Both males and females of all race/ethnic groups are eligible for participation in this study
- >=18 years of age
- Body mass index (BMI) >22 kg/m2. There is no maximal BMI provided that the weight does not exceed the weight allowance of the dual-energy x-ray absorptiometer (DXA) that is used to assess body composition (maximal weight for the DXA is 350 pounds)
- Ability to provide informed consent prior to participation in this study
- Ability to provide clearance from their kidney transplant physician to engage in the diet and physical activity components of the proposed intervention and to safely complete the proposed outcome measures
- Ability to walk for exercise
Who cannot take part
- Females who are pregnant, breastfeeding, or reporting a planned pregnancy during the study period. Female participants of childbearing age who are not currently taking contraceptive medication, are not post-menopausal, or have not been surgically sterilized will need to agree to use a double barrier method of contraception
- Currently prescribed an anti-obesity medication
- Current congestive heart failure, angina, uncontrolled arrhythmia, symptoms indicative of an increased acute risk for a cardiovascular event, prior myocardial infarction, coronary artery bypass grafting or angioplasty, conditions requiring chronic anticoagulation (i.e., recent or recurrent DVT)
- Currently treated for psychological issues (i.e., depression, bipolar disorder, etc.) that is accompanied by the following: 1) not on a stable dose of medications for treatment within the previous 12 months, or 2) hospitalized for depression within the previous 5 years
- History of bariatric surgery
- Report current medical condition or treatment for a medical condition that could affect body weight. These may include the following: diabetes mellitus; hyperthyroidism; inadequately controlled hypothyroidism; chronic liver disease; cancer; gastrointestinal disorders including ulcerative colitis, Crohn's disease, or malabsorption syndromes; etc
- Resting systolic blood pressure of >=160 mmHg or resting diastolic blood pressure of >=100 mmHg or not on a stable medical treatment to control hypertension (stable dose is defined as the same dose and type of medication for a period of at least 6 months)
- Eating disorders that would contraindicate modifying eating or physical activity behaviors
- Alcohol or substance abuse
- Report plans to relocate to a location not accessible to the study site or having employment, personal, or travel commitments that prohibit attendance at scheduled intervention sessions or assessments
Where in United States
- University of Kansas Medical CenterKansas City, United StatesContact: HEAL StudyTaking people
About the trial
What the trial wants to find out
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:
Read full original descriptionShow less
* 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.
The 2 groups in the trial
- Standard Medical CareExisting treatment, for comparison
Standard Care Intervention will continue to receive their regular standard clinical care during the 6-month intervention period of this study and will also receive brief conducts (\<10 minutes) from the research staff at weeks 6, 12, and 18.
Treatment: Standard medical care and Monitoring Contacts
- Standard Medical Care plus Lifestyle InterventionTreatment being tested
Standard Medical Care plus Lifestyle Intervention will continue to receive their regular standard clinical care and a behavioral intervention focused on dietary modification and physical activity for body weight regulation.
Treatment: Standard medical care, Behavioral Sessions, Diet, and Physical Activity
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Prevention of Weight Gain and Impaired Glucose Metabolism Post Kidney Transplantation: A Pilot and Feasibility Study
- Plain-language title
- Lifestyle program to prevent weight gain after kidney transplantGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 2 July 2026