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

May 30, 2025 updated by: John M. Jakicic, PhD, University of Kansas Medical Center

Prevention of Weight Gain and Impaired Glucose Metabolism Post Kidney Transplantation: A Pilot and Feasibility Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center
        • Principal Investigator:
          • John M. Jakicic, PhD
        • Principal Investigator:
          • Diane Cibrik, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard Medical Care
Standard 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.
Other: Standard medical care
Standard Care Intervention will continue to receive their regular standard clinical care during the 6-month intervention period of this study.
Behavioral: Monitoring Contacts
Participants will receive brief conducts (<10 minutes) remotely (telephone or video platform) with the research staff at weeks 6, 12, and 18.
Experimental: Standard Medical Care plus Lifestyle Intervention
Standard 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.
Other: Standard medical care
Standard Care Intervention will continue to receive their regular standard clinical care during the 6-month intervention period of this study.
Behavioral: Behavioral Sessions
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.
Behavioral: Diet
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.
Behavioral: Physical Activity
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Body Weight
Time Frame: 0 and 6 months
Body weight will be assessed in duplicate using a calibrated digital scale to the nearest 0.1 kg.
0 and 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body Mass Index
Time Frame: 0 and 6 months
Measurements of weight and height will be used to compute BMI (kg/m2).
0 and 6 months
Percent body fat
Time Frame: 0 and 6 months
Percent body fat will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA).
0 and 6 months
Body Fat Mass
Time Frame: 0 and 6 months
Body fat mass (kg) will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA).
0 and 6 months
Lean Body Mass
Time Frame: 0 and 6 months
Lean body mass (kg) will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA).
0 and 6 months
Bone mineral content
Time Frame: 0 and 6 months
Bone mineral content (grams) will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA).
0 and 6 months
Waist Circumference
Time Frame: 0 and 6 months
Circumference measures of the waist taken horizontally at both the iliac crest and the umbilicus will be performed.
0 and 6 months
Hip Circumference
Time Frame: 0 and 6 months
Circumference measures of the hip taken horizontally at widest portion of the buttocks will be performed.
0 and 6 months
Resting blood pressure
Time Frame: 0 and 6 months
Resting blood pressure will be measured in duplicate following a 5-minute seated rest period using an automated measuring system.
0 and 6 months
Resting heart rate
Time Frame: 0 and 6 months
Resting heart rate will be measured following a 5-minute seated rest period using an automated measuring system.
0 and 6 months
Physical Function
Time Frame: 0 and 6 months
Physical function will be measured with a 400-meter walk test. The score will be the duration of time (minutes) it takes to complete the 400 meters.
0 and 6 months
Fasting glucose
Time Frame: 0 and 6 months
Fasting glucose will be measured from a blood sample collected after at least an 8-hour fasting period.
0 and 6 months
Fasting Insulin
Time Frame: 0 and 6 months
Fasting insulin will be measured from a blood sample collected after at least an 8-hour fasting period.
0 and 6 months
Insulin Resistance
Time Frame: 0 and 6 months
HOMA-IR will be used as a measure of Insulin resistance, which is computed from measures of fasting glucose and fasting insulin.
0 and 6 months
Kidney function
Time Frame: 0 and 6 months
Kidney function will be measured using glomerular filtration rate (GFR) measured from a blood sample after at least 8 hours of fasting.
0 and 6 months
Physical activity
Time Frame: 0 and 6 months
Physical activity will be assessed with the Paffenbarger questionnaire that queries on walking, flights of stairs climbed, and other sport, recreational, or leisure physic activity. Physical activity is represented by the total minutes of activity per week and estimated kilocalories of physical activity per week.
0 and 6 months
Physical Activity
Time Frame: 0 and 6 months
Physical activity is measured by the Global Physical Activity Questionnaire (GPAQ). This assesses time spent in recreational, occupational, household, and transportation physical activities and is represented as minutes per week.
0 and 6 months
Sedentary behavior
Time Frame: 0 and 6 months
Sedentary behavior is measured using an 8-item survey that is completed for weekdays and weekend days. Time spent in sedentary behavior is reported.
0 and 6 months
Energy Intake (Dietary Intake)
Time Frame: 0 and 6 months
Energy Intake (Dietary Intake) expressed as kilocalories eaten per day (kcal/day) will be measured using the Diet History Questionnaire (DHQ) developed by NCI. A higher score represents more calories eaten.
0 and 6 months
Adverse and Serious Adverse Events
Time Frame: 0 and 6 months and at other times when reported by the participant
Participants will be queried using a survey developed specifically for this study will be used to assess for adverse events and serious adverse events.
0 and 6 months and at other times when reported by the participant
Health-Related Quality of Life
Time Frame: 0 and 6 months
Health-Related Quality of Life will be measured with a 36-item questionnaire (RAND 36-Item Health Survey) that includes 8 subscales of vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health or emotional wellbeing. All items are scored so that a high score defines a more favorable health state. The range of the final score for each subscale is 0-100.
0 and 6 months
Weight Loss Strategies
Time Frame: 0 and 6 months
Weight Loss Strategies will be measured using the Weight Control Strategies Scale that includes 30 items. Each item is scored on a 0-4 scale and the scores across the 30 items are summed to provide an overall score, with a range for the total score being 0 to 120. A higher score is more favorable and represents engaging in more weight control strategies.
0 and 6 months
Weight Loss Strategies
Time Frame: 0 and 6 months
Weight Loss Strategies will be measured using the Eating Behavior Inventory that includes 26 items with each measured on a 5-point scale. The score from each item is summed for a total score, with the being 26-130. A higher score represents engaging in more appropriate weight loss strategies.
0 and 6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Medication History
Time Frame: 0 and 6 months
A questionnaire developed specifically for this study will be used to assessment medication history. The data collected include the type of medication, dose of medication, and frequency that the medication is taken, and what condition the medication is indicated to treat.
0 and 6 months
Lifestyle and Health History
Time Frame: 0 months (prior to randomization)
A questionnaire developed specifically for this study that is conducted as an interview will be used to assess lifestyle and health factors to describe the sample for this study. The score is either "yes" or "no" identifying the presences of a lifestyle or health factor.
0 months (prior to randomization)
Post-Intervention Qualitative Interview
Time Frame: 6 months
Each participant will undergo a qualitative interview in a face-to-face format to allow the investigators to better understand strengths, weaknesses, and barriers that will allow for further intervention refinement prior to proceeding a larger study.
6 months
Post-Intervention Qualitative Questionnaire
Time Frame: 6 months
Each participant will complete a questionnaire to allow the investigators to better understand strengths, weaknesses, and barriers that will allow for further intervention refinement prior to proceeding a larger study.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Kansas Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John M. Jakicic, PhD, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 17, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY001680081
  • R01DK137986-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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