Lifestyle intervention for weight management in kidney transplant recipients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the feasibility and potential effectiveness of a lifestyle intervention designed to prevent weight gain in kidney transplant recipients. Participants will be recruited within 3-5 months post-transplant and will be randomized to receive either standard medical care or standard care plus a lifestyle intervention that includes dietary and physical activity components. The study will assess patient engagement, compliance, and any adverse events related to the interventions, as well as changes in weight and cardiometabolic biomarkers. The goal is to determine if the lifestyle intervention can provide additional benefits compared to standard care alone.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Kansas Medical Center
  Kansas City, Kansas, United States Recruiting

Study contacts

• Principal investigator: John M. Jakicic, PhD — University of Kansas Medical Center
• Study coordinator: John M. Jakicic, PhD
• Email: jjakicic@kumc.edu
• Phone: 913-588-9078

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.