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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK137986-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Body Weight | Body weight will be assessed in duplicate using a calibrated digital scale to the nearest 0.1 kg. | 0 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index | Measurements of weight and height will be used to compute BMI (kg/m2). | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Medication History | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| John M. Jakicic, PhD | Contact | 913-588-9078 | jjakicic@kumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| John M. Jakicic, PhD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Recruiting | Kansas City | Kansas | 66160 | United States |
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.
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.
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.
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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). | 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). | 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). | 0 and 6 months |
| Waist Circumference | Circumference measures of the waist taken horizontally at both the iliac crest and the umbilicus will be performed. | 0 and 6 months |
| Hip Circumference | Circumference measures of the hip taken horizontally at widest portion of the buttocks will be performed. | 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. | 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. | 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. | 0 and 6 months |
| Fasting glucose | Fasting glucose will be measured from a blood sample collected after at least an 8-hour fasting period. | 0 and 6 months |
| Fasting Insulin | Fasting insulin will be measured from a blood sample collected after at least an 8-hour fasting period. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 0 and 6 months and at other times when reported by the participant |
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 | 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 | 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 |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004032 | Diet |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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