Feasibility and Plausible Effectiveness of a Lifestyle Intervention in Kidney Transplant Recipients (HEAL)
HEAL
Prevention of Weight Gain and Impaired Glucose Metabolism Post Kidney Transplantation: A Pilot and Feasibility Study
2 other identifiers
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2024
CompletedFirst Posted
Study publicly available on registry
October 15, 2024
CompletedStudy Start
First participant enrolled
December 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
June 4, 2025
May 1, 2025
1.8 years
October 10, 2024
May 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Body Weight
Body weight will be assessed in duplicate using a calibrated digital scale to the nearest 0.1 kg.
0 and 6 months
Secondary Outcomes (22)
Body Mass Index
0 and 6 months
Percent body fat
0 and 6 months
Body Fat Mass
0 and 6 months
Lean Body Mass
0 and 6 months
Bone mineral content
0 and 6 months
- +17 more secondary outcomes
Other Outcomes (4)
Medication History
0 and 6 months
Lifestyle and Health History
0 months (prior to randomization)
Post-Intervention Qualitative Interview
6 months
- +1 more other outcomes
Study Arms (2)
Standard Medical Care
ACTIVE COMPARATORStandard Care Intervention will continue to receive their regular standard clinical care during the 6-month intervention period of this study and will also receive brief conducts (\<10 minutes) from the research staff at weeks 6, 12, and 18.
Standard Medical Care plus Lifestyle Intervention
EXPERIMENTALStandard Medical Care plus Lifestyle Intervention will continue to receive their regular standard clinical care and a behavioral intervention focused on dietary modification and physical activity for body weight regulation.
Interventions
Standard Care Intervention will continue to receive their regular standard clinical care during the 6-month intervention period of this study.
Participants will receive brief conducts (\<10 minutes) remotely (telephone or video platform) with the research staff at weeks 6, 12, and 18.
Participants will be provided weekly individual behavioral sessions during the 6-month intervention to assist in supporting recommended changes in energy intake (diet) and physical activity.
An energy balanced diet to meet energy needs that will allow for weight maintenance will be prescribed. This will be estimated using the Mifflin-St. Joer equation to estimate resting metabolic rate and for most participants we anticipate using a physical activity correction of 1.3 to account for energy needs for physical activity. This will provide the initial estimate of energy intake needs to maintain weight stability; however, the prescribed level of energy intake will be adjusted at 4-week intervals across the intervention based on the observed changes in weight, eating behaviors, and physical activity patterns in an effort to prevent excessive weight gain. Within the context of this level of energy intake, we will prescribe a diet that is consistent with the dietary recommendations of the National Kidney Foundation.
Physical activity will be recommended in the form of aerobic types of activity such as brisk walking and will progress in 4-week intervals from an initial amount of 50 minutes per week to 150 minutes per week across the initial 6 months of the intervention. Moderate intensity will be prescribed, and will be anchored using RPE (rating of perceived exertion) to allow intensity to be self-regulated according to the participant's capacity. Physical activity will be prescribed in the form of walking; however, the participant will be permitted to engage in other forms of physical activity that meet the recommended dose and intensity.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John M. Jakicic, PhD
University of Kansas Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 10, 2024
First Posted
October 15, 2024
Study Start
December 17, 2024
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
March 1, 2027
Last Updated
June 4, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- The data will be made available no later than the time of an associated publication of study outcomes or at the end of the performance period, whichever comes first. The data provided to the repository will be available indefinitely while that repository continues to exist.
- Access Criteria
- The information included with the IPD will be made available to appropriate individuals only after the requester confirms their willingness to comply with an appropriate "Data Use Agreement" that complies with NIH policies, the policies of the institution where the study has been conducted, and the elements of informed consent.
The summary data for each of the study outcomes and other additional demographic characteristics will be made available. The Study Protocol (which includes the statistical analysis plan), Manual of Procedures, Data Collection Forms, and a Data Dictionary to explain the data variables will be provided.