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NCT Number: NCT06640179

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

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.

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Key information

Conditions

Kidney Transplant Body Weight Glucose Control Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight or Obese Adults Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location status: Recruiting

Location contact

Diane Cibrik, MD

PRINCIPAL_INVESTIGATOR

HEAL Study

CONTACT

[email protected]

913-588-5882

John M. Jakicic, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard Medical Care

Other

Standard Care Intervention will continue to receive their regular standard clinical care during the 6-month intervention period of this study.

Monitoring Contacts

Behavioral

Participants will receive brief conducts (<10 minutes) remotely (telephone or video platform) with the research staff at weeks 6, 12, and 18.

Behavioral Sessions

Behavioral

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.

Diet

Behavioral

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

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Body Mass Index

    Time frame: 0 and 6 months

    Measurements of weight and height will be used to compute BMI (kg/m2).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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.

  7. Hip Circumference

    Time frame: 0 and 6 months

    Circumference measures of the hip taken horizontally at widest portion of the buttocks will be performed.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

John M. Jakicic, PhD

CONTACT

[email protected]

913-588-9078

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Acronym: HEAL

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 15, 2024
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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