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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
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.
University of Kansas Medical Center
Kansas City, Kansas, United States
RECRUITINGBody Weight
Body weight will be assessed in duplicate using a calibrated digital scale to the nearest 0.1 kg.
Time frame: 0 and 6 months
Body Mass Index
Measurements of weight and height will be used to compute BMI (kg/m2).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 0 and 6 months
Waist Circumference
Circumference measures of the waist taken horizontally at both the iliac crest and the umbilicus will be performed.
Time frame: 0 and 6 months
Hip Circumference
Circumference measures of the hip taken horizontally at widest portion of the buttocks will be performed.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 0 and 6 months
Fasting glucose
Fasting glucose will be measured from a blood sample collected after at least an 8-hour fasting period.
Time frame: 0 and 6 months
Fasting Insulin
Fasting insulin will be measured from a blood sample collected after at least an 8-hour fasting period.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 0 and 6 months and at other times when reported by the participant
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