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

Launched by UNIVERSITY OF KANSAS MEDICAL CENTER · Oct 11, 2024

Keywords

ClinConnect Summary

This clinical trial is looking to see if a lifestyle intervention, which encourages changes in diet and physical activity, can help prevent weight gain in adults who have recently received a kidney transplant. The study will compare the usual medical care these patients receive with the same care plus the lifestyle changes. Researchers want to find out if it's possible to recruit and keep participants in the study, if they will stick to the lifestyle changes, and if these changes will improve their health in various ways, such as better blood sugar control and overall quality of life.

To participate, individuals must be at least 18 years old, have received a kidney transplant within the last 3 to 5 months, and have a body mass index (BMI) over 22. They should also be cleared by their kidney transplant doctor to engage in physical activity. Participants will continue with their standard medical care and attend weekly sessions focused on lifestyle changes for six months. They will also complete health assessments at the beginning and end of the study to track their progress. This trial is currently recruiting participants, and it's an opportunity for those eligible to potentially improve their health after a kidney transplant.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.