The Use of a Consumer-Based mHealth Dietary App and Health Coaching With Kidney Transplant Recipients

Study Overview
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Brief Summary
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The purpose of the study is to test the feasibility mHealth dietary app + health coaching for improving primary outcomes (recruitment, retention, and adherence) and secondary outcomes (perceived stress [ Perceived Stress Scale], exercise self-efficacy[Exercise Self-efficacy Scale], vegetable intake [Fruit, Vegetables, and Fiber Screen] fat intake [Lose-it Premium database], carbohydrate intake [Lose-it Premium database], weight, [Wi-Fi weight scale using the Lose-it Premium database], and blood pressure [Wi-Fi blood pressure cuff using the Lose-it Premium database].

Detailed Description
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The proposed study seeks to shift the paradigm for promoting diet intake and physical activity using education and self-report to provide a powerful combination of mHealth dietary app and health coaching (set goals, provide ongoing feedback, and self-monitor behaviors). To the investigators knowledge, this is the first time a mHealth dietary app and health coaching intervention has been used in kidney transplant recipients to link real-time data for monitoring dietary intake and physical activity. The long-term goal of this work is to enhance well-being in kidney recipients via lifestyle self-management of care for dietary intake and physical activity to ultimately prevent chronic diseases. The proposed study is important because early weight gain after kidney transplant is associated with adverse effects on the transplanted kidney function resulting in increased health care cost and poor quality of life. Interventions are needed to monitor kidney transplant recipients diet and physical activity in real-time to prevent health decline.

Official Title
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The Use of a Consumer-Based mHealth Dietary App and Health Coaching With Kidney Transplant Recipients

Conditions
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Kidney Transplant, Kidney Transplant; Complications

Intervention / Treatment
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* Behavioral: mHealth dietary app + health coaching intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 or older men and women functioning KTR (not on dialysis) ability to speak, read, and hear English, possession of a smartphone capable of accessing and downloading a mHealth dietary app Wi-Fi or Internet access, greater than 3 months post-transplant (due to medication adjustments and decreased functional levels), not hospitalized capable of self-consent per capacity screening. Exclusion Criteria: Participation in a weight loss program participation in a structured exercise program diagnosis of dementia.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| mHealth dietary app + health coaching intervention<br>A feasibility study will be utilized to establish the recruitment, retention, and adherence with post-kidney transplant recipients using a consumer-based mHealth dietary app + health coaching. | Behavioral: mHealth dietary app + health coaching intervention<br>* The Lose-It app will be set up with Gmail accounts with unique unidentifiable codes developed by the research team. Participants be trained to enter their dietary intake and physical activity daily for 12-weeks. Participants will monitor their vegetable intake, fat intake, carbohydrate intake, weight, and blood pressure. Wi-Fi connected weight scales and blood pressure cuff will be supplied for weight and blood pressure monitoring. Participants will be taught how to sync the data from the scales and blood pressure cuff to the app for the research team to access. Participants will perform a return demonstration to confirm that they can record their dietary intake daily, physical activity, weight, and blood pressure using the Lose-It app. We also review with the participant the My Plate method for proper nutrition and the steps to distance conversion chart.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Feasibility of the study Recruitment for the Study | Recruitment (percent of participants approached to be in the study), will be recorded by the research assistant. | Baseline | 
| The Feasibility of Participant Retention for the Study | Retention (percent of participants that dropped during the study), will be recorded by the research assistant. | To assess for a change in participant retention from Baseline, 4 weeks, 8 weeks, and 12 weeks | 
| The Feasibility of Adherence for using the Lose- It App to Record Diet and Physical Actvity | Adherence (percent to adhere to logging daily dietary intake and physical activity) will be recorded continuously each day by the Lose-It app. | To assess for a change in participant adherence from Baseline, 4 weeks, 8 weeks, and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Stress Level | Perceived Stress Scale will be evaluated by using the Perceived Stress Scale (PSS).The PSS is a 10-item questionnaire using a Likert Scale to rate feelings of stress from 0 never to 4 very often. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise. | To assess for a change in participant perceived stress from Baseline, 4 weeks, 8 weeks, and 12 weeks | 
| Exercise Self-Efficacy | Exercise Self-Efficacy Scale will be evaluated by using the Self-Efficacy for Exercise (SEE) Scale. The SEE is a 9-item questionnaire using a Likert Scale to rate feelings of stress from 0 not confident to 10 very confident. | To assess for a change in participant exercise self-efficacy from Baseline, 4 weeks, 8 weeks, and 12 weeks | 
| Fruit and Vegetable Intake | Fruit and vegetable intake will be assessed using the Fruit, Vegetable and Fiber Screen which uses a scale to assess fruit and vegetable intake using a Likert Scale to rate intake from less than1/ per week to more than 2 a day. | To assess for a change in participant fruit, vegetable, and fiber intake from Baseline, 4 weeks, 8 weeks, and 12 weeks | 
| Fiber Intake | Fiber intake will be assessed using the Fruit, Vegetable and Fiber Screen which uses a scale to assess fruit and vegetable intake using a Likert Scale to rate intake from less than1/ per week to more than 2 a day. | To assess for a change in participant fruit, vegetable, and fiber intake from Baseline, 4 weeks, 8 weeks, and 12 weeks | 
| Fat Intake | The participant will record their percent of fat intake each day into the Lose-it Premium application. | To assess for a change in participant fat intake from Baseline, 4 weeks, 8 weeks, and 12 weeks | 
| Carbohydrate Intake | The participant will record their percent of carbohydrate intake each day into the Lose-it Premium application. | To assess for a change in participant carbohydrate intake from Baseline, 4 weeks, 8 weeks, and 12 weeks | 
| Weight | Weight (pounds) will be measured each day by the participant using a wireless Wi Fi weight scale. The data from the wireless weight scale will sync the data from the participant's mobile phone to the premium password-protect Lose-It database each day. | To assess for a change in participant weight from Baseline, 4 weeks, 8 weeks, and 12 weeks | 
| Systolic Blood Pressure | Systolic blood pressure (millimeters of mercury [mmHg]) will be recorded each day by the participant using a wireless Wi Fi blood pressure cuff. The data from the wireless cuff will sync from the participant's mobile phone to the premium password-protect Lose-It database each day. | To assess for a change in participant systolic blood pressure from Baseline, 4 weeks, 8 weeks, and 12 weeks | 
| Diastolic Blood Pressure | Systolic blood pressure (millimeters of mercury [mmHg]) will be recorded each day by the participant using a wireless Wi Fi blood pressure cuff. The data from the wireless cuff will sync from the participant's mobile phone to the premium password-protect Lose-It database each day. | To assess for a change in participant diastolic blood pressure from Baseline, 4 weeks, 8 weeks, and 12 weeks |