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Lifestyle Intervention for Kidney Transplant Recipients (HEAL)

This study, called HEAL, is looking at whether a lifestyle program can help kidney transplant recipients prevent weight gain. It compares standard medical care to standard care plus a lifestyle intervention that includes weekly behavioral sessions focused on diet and physical activity. The main goal is to see if it's practical to recruit and keep participants in such a study, and if they will follow the intervention. You could join if you are an adult (18 years or older) who received a kidney transplant 3-5 months ago and are overweight or obese. The study will measure your body weight at the beginning and after 6 months to see if the intervention is effective.

Study design
This interventional study plans to enroll 60 participants. It compares standard medical care to standard medical care plus a lifestyle intervention.
What's involved
If you participate, you will receive weekly individual behavioral sessions for 6 months, along with brief remote monitoring contacts at weeks 6, 12, and 18. Your body weight will be measured at the start and after 6 months.
Compensation
Not stated in the trial record.
Follow-up
Your body weight will be measured at 0 and 6 months, indicating a follow-up period of at least 6 months.

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NCT06640179

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

Recruiting
NAAges 18+InterventionalTreatment
University of Kansas Medical Center
~60 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:Standard medical careMonitoring ContactsBehavioral SessionsDietPhysical Activity

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Body Weight
Measured over 0 and 6 months

Conditions

Kidney Transplant
Overweight or Obese Adults
Glucose Control

Explore related trials

Kidney TransplantationObesityOverweight

Where it's being run

1 sites across 1 states
Kansas1

Study leadership

  • John M. Jakicic, PhD · PRINCIPAL_INVESTIGATOR · University of Kansas Medical Center

Who to contact

John M. Jakicic, PhD
[email protected]
913-588-9078
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.
History of bariatric surgery.
Currently prescribed an anti-obesity medication.
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.
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).
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.
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.
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.

What this trial measures

  • Body Weight0 and 6 months

    Body weight will be assessed in duplicate using a calibrated digital scale to the nearest 0.1 kg.