Kidney TransplantHEALNCT06640179
Feasibility and Plausible Effectiveness of a Lifestyle Intervention in Kidney Transplant Recipients (HEAL)
A study testing Standard medical care, Monitoring Contacts and Behavioral Sessions in people with Kidney Transplant and Overweight or Obese Adults, run by University of Kansas Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant, Overweight or Obese Adults, Glucose Control
- What is being tested?
- Standard medical care, Monitoring Contacts and Behavioral Sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2024to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
HEAL Study, 913-588-5882, jjakicic@kumc.edu
John M. Jakicic, PhD
About this study
Official title: 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?
Read more
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.
- Being tested
- Standard medical care, Monitoring Contacts, Behavioral Sessions, Diet, Physical Activity
- Keywords
- kidney transplant, overweight, obesity, glucose control, weight control
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard medical careOther
Standard Care Intervention will continue to receive their regular standard clinical care during the 6-month intervention period of this study.
Monitoring ContactsBehavioural
Participants will receive brief conducts (<10 minutes) remotely (telephone or video platform) with the research staff at weeks 6, 12, and 18.
Behavioral SessionsBehavioural
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.
DietBehavioural
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 ActivityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Medical Care | Active comparator | 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. Receives: Other: Standard medical care; Behavioral: Monitoring Contacts |
| Standard Medical Care plus Lifestyle Intervention | Experimental | 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. Receives: Other: Standard medical care; Behavioral: Behavioral Sessions; Behavioral: Diet; Behavioral: Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
Body weight will be assessed in duplicate using a calibrated digital scale to the nearest 0.1 kg.
Measured: 0 and 6 months
Secondary outcomes (22)
Body Mass Index
Measurements of weight and height will be used to compute BMI (kg/m2).
Measured: 0 and 6 months
Percent body fat
Percent body fat will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA).
Measured: 0 and 6 months
Body Fat Mass
Body fat mass (kg) will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA).
Measured: 0 and 6 months
Lean Body Mass
Lean body mass (kg) will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA).
Measured: 0 and 6 months
Bone mineral content
Bone mineral content (grams) will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA).
Measured: 0 and 6 months
Waist Circumference
Circumference measures of the waist taken horizontally at both the iliac crest and the umbilicus will be performed.
Measured: 0 and 6 months
Hip Circumference
Circumference measures of the hip taken horizontally at widest portion of the buttocks will be performed.
Measured: 0 and 6 months
Resting blood pressure
Resting blood pressure will be measured in duplicate following a 5-minute seated rest period using an automated measuring system.
Measured: 0 and 6 months
Resting heart rate
Resting heart rate will be measured following a 5-minute seated rest period using an automated measuring system.
Measured: 0 and 6 months
Physical Function
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.
Measured: 0 and 6 months
Fasting glucose
Fasting glucose will be measured from a blood sample collected after at least an 8-hour fasting period.
Measured: 0 and 6 months
Fasting Insulin
Fasting insulin will be measured from a blood sample collected after at least an 8-hour fasting period.
Measured: 0 and 6 months
Insulin Resistance
HOMA-IR will be used as a measure of Insulin resistance, which is computed from measures of fasting glucose and fasting insulin.
Measured: 0 and 6 months
Kidney function
Kidney function will be measured using glomerular filtration rate (GFR) measured from a blood sample after at least 8 hours of fasting.
Measured: 0 and 6 months
Physical activity
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.
Measured: 0 and 6 months
Physical Activity
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.
Measured: 0 and 6 months
Sedentary behavior
Sedentary behavior is measured using an 8-item survey that is completed for weekdays and weekend days. Time spent in sedentary behavior is reported.
Measured: 0 and 6 months
Energy Intake (Dietary Intake)
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.
Measured: 0 and 6 months
Weight Loss Strategies
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.
Measured: 0 and 6 months
Weight Loss Strategies
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.
Measured: 0 and 6 months
Health-Related Quality of Life
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.
Measured: 0 and 6 months
Adverse and Serious Adverse Events
Participants will be queried using a survey developed specifically for this study will be used to assess for adverse events and serious adverse events.
Measured: 0 and 6 months and at other times when reported by the participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start17 Dec 2024
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John M. Jakicic, PhD, University of Kansas Medical Center
- Investigators
- John M. Jakicic, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640179
- Sponsor's protocol ID
- STUDY001680081
- Other IDs
- R01DK137986-01
- Acronym
- HEAL
- Status last verified
- Jun 2026
- First submitted
- 10 Oct 2024
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Weight Gain and Impaired Glucose Metabolism Post Kidney Transplantation: A Pilot and Feasibility Study
- ClinicalTrials.gov ID
- NCT06640179
- Acronym / sponsor ID
- HEAL / STUDY001680081
- Keywords
- kidney transplant, overweight, obesity, glucose control, weight control
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 17 Dec 2024 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Medical Care | Active comparator | Other: Standard medical care, Behavioral: Monitoring ContactsStandard 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 | Experimental | Other: Standard medical care, Behavioral: Behavioral Sessions, Behavioral: Diet, Behavioral: Physical ActivityStandard 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard medical careStandard Care Intervention will continue to receive their regular standard clinical care during the 6-month intervention period of this study. | Other | Standard Medical Care, Standard Medical Care plus Lifestyle Intervention |
| Monitoring ContactsParticipants will receive brief conducts (<10 minutes) remotely (telephone or video platform) with the research staff at weeks 6, 12, and 18. | Behavioural | Standard Medical Care |
| Behavioral SessionsParticipants 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. | Behavioural | Standard Medical Care plus Lifestyle Intervention |
| DietAn 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. | Behavioural | Standard Medical Care plus Lifestyle Intervention |
| Physical ActivityPhysical 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. | Behavioural | Standard Medical Care plus Lifestyle Intervention |
Primary outcome
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.
22 secondary outcomes
Body Mass Index
Time frame: 0 and 6 months
Percent body fat
Time frame: 0 and 6 months
Body Fat Mass
Time frame: 0 and 6 months
Lean Body Mass
Time frame: 0 and 6 months
Bone mineral content
Time frame: 0 and 6 months
Waist Circumference
Time frame: 0 and 6 months
Hip Circumference
Time frame: 0 and 6 months
Resting blood pressure
Time frame: 0 and 6 months
Resting heart rate
Time frame: 0 and 6 months
Physical Function
Time frame: 0 and 6 months
Fasting glucose
Time frame: 0 and 6 months
Fasting Insulin
Time frame: 0 and 6 months
Insulin Resistance
Time frame: 0 and 6 months
Kidney function
Time frame: 0 and 6 months
Physical activity
Time frame: 0 and 6 months
Physical Activity
Time frame: 0 and 6 months
Sedentary behavior
Time frame: 0 and 6 months
Energy Intake (Dietary Intake)
Time frame: 0 and 6 months
Weight Loss Strategies
Time frame: 0 and 6 months
Weight Loss Strategies
Time frame: 0 and 6 months
Health-Related Quality of Life
Time frame: 0 and 6 months
Adverse and Serious Adverse Events
Time frame: 0 and 6 months and at other times when reported by the participant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John M. Jakicic, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard medical care, Monitoring Contacts and Behavioral Sessions in people with Kidney Transplant and Overweight or Obese Adults, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John M. Jakicic, PhD (913-588-9078, jjakicic@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight (time frame: 0 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.