feasibility and plausible effectiveness of a lifestyle intervention in kidney transplant recipients (heal)

Conditions: Kidney Transplant; Overweight or Obese Adults; Glucose Control

Summary: 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.


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.

Keywords: kidney transplant overweight obesity glucose control weight control