Clinical trial NCT06640179: Feasibility and Plausible Effectiveness of a Lifestyle Intervention in Kidney Transplant Recipients (HEAL)
Official title: Prevention of Weight Gain and Impaired Glucose Metabolism Post Kidney Transplantation: A Pilot and Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Transplant
Overweight or Obese Adults
Glucose Control
Keywords: kidney transplant
overweight
obesity
glucose control
weight control
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-10-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Body Weight
timeFrame: 0 and 6 months
Secondary outcomes:
measure: Body Mass Index
timeFrame: 0 and 6 months
measure: Percent body fat
timeFrame: 0 and 6 months
measure: Body Fat Mass
timeFrame: 0 and 6 months
measure: Lean Body Mass
timeFrame: 0 and 6 months
measure: Bone mineral content
timeFrame: 0 and 6 months
measure: Waist Circumference
timeFrame: 0 and 6 months
measure: Hip Circumference
timeFrame: 0 and 6 months
measure: Resting blood pressure
timeFrame: 0 and 6 months
measure: Resting heart rate
timeFrame: 0 and 6 months
measure: Physical Function
timeFrame: 0 and 6 months
measure: Fasting glucose
timeFrame: 0 and 6 months
measure: Fasting Insulin
timeFrame: 0 and 6 months
measure: Insulin Resistance
timeFrame: 0 and 6 months
measure: Kidney function
timeFrame: 0 and 6 months
measure: Physical activity
timeFrame: 0 and 6 months
measure: Physical Activity
timeFrame: 0 and 6 months
measure: Sedentary behavior
timeFrame: 0 and 6 months
measure: Energy Intake (Dietary Intake)
timeFrame: 0 and 6 months
measure: Weight Loss Strategies
timeFrame: 0 and 6 months
measure: Weight Loss Strategies
timeFrame: 0 and 6 months
measure: Health-Related Quality of Life
timeFrame: 0 and 6 months
measure: Adverse and Serious Adverse Events
timeFrame: 0 and 6 months and at other times when reported by the participant
Other outcomes:
measure: Medication History
timeFrame: 0 and 6 months
measure: Lifestyle and Health History
timeFrame: 0 months (prior to randomization)
measure: Post-Intervention Qualitative Interview
timeFrame: 6 months
measure: Post-Intervention Qualitative Questionnaire
timeFrame: 6 months
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: John M. Jakicic, PhD
role: PRINCIPAL_INVESTIGATOR
References: