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

Part of paid clinical trials in Kansas City, Kansas.

Sponsor
University of Kansas Medical Center
Study ID
NCT06640179
Status
Recruiting
Apply to this trial

Conditions

  • Glucose Control
  • Kidney Transplant
  • Overweight or Obese Adults

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Dec 17, 2024
Status verified
May 2025
Primary completion
Oct 1, 2026
Completion
Mar 1, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Body Weight [ Time Frame: 0 and 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Kansas Medical CenterKansas CityKansas66160
HEAL Study
[email protected]
913-588-5882
John M. Jakicic, PhD (PRINCIPAL_INVESTIGATOR)
Diane Cibrik, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Kansas City, KS

By research site
University of Kansas Medical Center· Kansas City, KS

Related Studies