The Use of a Consumer-Based mHealth Dietary App and Health Coaching With Kidney Transplant Recipients
Conditions: Kidney Transplant, Kidney Transplant; Complications
Sponsor: Ohio State University

  
 
 
 
 
Official Title:  
 The Use of a Consumer-Based mHealth Dietary 
App and Health Coaching with Kidney Transplant 
Recipients Study Information 
NCT Number: NCT05151445 
Document Name: Study Protocol and Statistical analysis Plan 
Document Date: 05/05/2021 

  
 
 
 
Study/Project Title:  The Use of a Consumer-Based mHealth Dietary App and Health Coaching 
with Kidney Transplant Recipients   
 
 
I. Objectives 
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, blood pressure [Wi-Fi weight scale using the Lose-it Premium database], 
heart rate [Wi-Fi blood pressure cuff using the Lose-it Premium database],  and the minutes of physical 
activity per day [Lose-it Premium database]) 
 
Background and Rationale Weight gain and obesity are common after kidney transplant, often leading to 
the development of cardiovascular disease, post-transplant diabetes, and death.1 The increase in weight 
gain during the first year after transplant is associated with the use of immunosuppressive medications, and 
changes in lifestyle, such as dietary intake and insufficient physical activity. Moreover, weight gain is 
affected by factors such as, age, sex, race, and stress.2 Evidence indicates that kidney transplant recipients 
who gain less weight after transplant are physically active, consume fewer carbohydrates, consume more 
vegetables, and experienced less stress.3 Further, limiting dietary fat and increasing post-kidney energy 
expenditures aid in preventing early insulin resistance and cardiovascular disease.4 5 
 
However, few studies have tested dietary and physical activity interventions using real-time mobile health 
applications (mHealth) to enhance lifestyle self-management of care with kidney transplant receipents.6  
 
Our 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 our 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.7 
Interventions are needed to monitor kidney transplant recipients diet and physical activity in real-time to 
prevent health decline. 
 
The goal of the proposed feasibility study is to recruit a sample (N = 20) of post-kidney transplant 
recipients (age 18 and above) who will receive the mHealth dietary app + health coaching intervention for 
12 weeks. We will assess changes over time for the primary outcome and secondary outcomes from 
baseline to 4, 8, and 12 weeks. We plan to submit our findings for publication to the Journal of Progress of 
Transplantation (Impact factor 0.958) or Trends in Transplantation (Impact factor 0.1.69). We hypothesize 
that the mHealth dietary app + health coaching intervention will improve adherence for recording diet and 
physical activity, decrease perceived stress,  increase exercise self-efficacy, increase vegetable intake,  
decrease fat intake, decrease carbohydrate intake,  improve weight control,  improve blood pressure 
control, improve heart rate and an increase the number of minutes of physical activity per day. We will 

  
 
also examine biological differences among the secondary outcomes of perceived stress, exercise self-
efficacy, vegetable intake, fat intake, carbohydrate intake, weight, blood pressure, heart rate and minutes 
of physical activity per day, as previous studies have reported differences in outcomes based on age, sex, 
and race.8,9 The rationale for our hypothesis is that progression of cardiovascular disease and chronic 
disease may be slowed with daily tracking of dietary and physical activity.  
 
 
II. Procedures 
The procedures should include the following: 
 
A. Research Design 
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. 
 
B. Sample 
 
Inclusion Criteria 
(a) age 18 or older men and women, (b) functioning KTR (not on dialysis), (c) ability to speak, read, 
and hear English, (d) possession of a smartphone capable of accessing and downloading a mHealth 
dietary app (e) Wi-Fi or Internet access, (f) greater than 3 months post-transplant (due to medication 
adjustments and decreased functional levels), (g) not hospitalized, and (h) capable of self-consent per 
capacity screening.32 
 
 Exclusion Criteria 
(a) Participation in a weight loss program, (b) participation in a structured exercise program, and (c) 
diagnosis of dementia. 
 
How will subjects be selected? 
 
The participants will be recruited or contacted from a list of kidney recipients that have already 
requested they be contacted for future studies from our previous study (IRB Protocol Number: 
2017B0084). This list consists of approximately 60 people.  This study will also be advertised at the 
Ohio State University Medical Center Kidney Transplant monthly support group. Fliers with study 
information will be made available at the support group. The support group leader will also inform 
the group participants about the study. 
 
After participants meet the initial screening requirements in the recruitment process, we will 
determine capacity to obtain verbal consent using the Evaluation to Sign Consent Form (ESC). The 
ESC consists of five questions (“What are risks associated with the study?” “What are two potential 
risks for participating in the study?” “What is expected from you in this study?” “What if you do not 
want to continue the study?” “What if you experience discomfort?”) and takes less than 10 minutes 
to complete. The ESC allows the participant to reflect upon their understanding of the research 
protocol by answering the five questions. Participants must answer all five questions correctly to be 
included in the study. Anybody who is able to answer all five questions correctly will then be read 
verbal consent script by the study team. 
 
C. Measurement / Instrumentation 
Participant Demographic Information (10 minutes) will be obtained using a seven-item 
questionnaire demographics form and Comorbidity Data will be gathered using the Charlson 
Comorbidity Index33  to describe the patient population. Aim 1: Recruitment (percent approached), 

  
 
will be recorded in REDCap by the RA. Retention (percent dropped) will be recorded in REDCap by 
the RA. Adherence (percent to adhere to logging daily dietary intake and physical activity) will be 
recorded continuously each day by the “Lose-It” app. Aim 2: Perceived Stress (10 minutes) will be 
evaluated by using the Perceived Stress Scale (PSS).35 The PSS is a 10-item questionnaire using a 
Likert Scale to rate feelings of stress from 0 “never” to 4 “very often.”   The PSS has demonstrated 
excellent test-retest reliability (intraclass correlation coefficient = 0.954) and internal consistency 
(Cronbach's alpha = 0.810) with adults who have chronic disease.36 Exercise Self-Efficacy (10 
minutes) 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.” The SEE has demonstrated excellent internal consistency (α = 0.92) for adults living with 
chronic disease.37 Vegetable intake will be measured using the Block Fruit-Vegetable-Fiber 
Screener. The Block Fruit-Vegetable-Fiber Screener (5 minutes) has demonstrated high reliability 
(Spearman r-value of 0.71).38 This brief screening tool includes seven questions about fruit and 
vegetable intake and three questions about foods high in fiber, magnesium, and potassium. Fat 
Intake and Carbohydrate Intake (5 minutes) will be recorded each day by the participant using the 
“Lose-It” app. Weight 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. Blood Pressure and Heart Rate 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. Minutes of Physical Activity per Day will be recorded each day by the 
participant using the “Lose-It” app. Clinical Frailty Scale (5 minutes) will be used to measure the 
frailty level of each participant. The screening tool has demonstrated high reliability in adults. This 
brief screening tool consist of nine questions about  a person’s level of frailty. 
 
 
D. Detailed study procedures 
 
The “Lose-It” app will be set up with Gmail accounts with unique unidentifiable codes developed by the 
research team.  Participants will be instructed how to download the “Lose-It” app virtually using Zoom. In 
addition, participants will be taught how to sync to their smartphone and retrieve data from their app. The 
participants will 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, blood pressure, 
heart rate and the minutes of physical activity per day using the “Lose-It” app. 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 “Lose-It” app using the 
Premium database which will Sync all of the data into password protected database 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. Each 
participant will be given a copy of both via email.   
 
 
Session 
mHealth App + Health Coaching Intervention 
Setting: Online video- conference call (Zoom) 
Baseline 
Session 
(Session 1)  
 
Time for 
session: 90 
minutes 
 
The research assistant (RA) will demonstrate proper “Lose-It” app use, set up the 
smartphone application, and how to enter their dietary intake, physical activity, weight, 
blood pressure, heart rate and the minutes of physical activity per day using the “Lose-It” 
app. The RA will demonstrate how to sync the data from the Wi Fi weight scales and blood 
pressure cuff to the “Lose-It” app. 
Participants will perform a return demonstration to confirm that they can access the “Lose-
It” app, sync the data from the Wi Fi scales and blood pressure cuff. 

  
 
 
Week 1-12 
(Sessions 
2-13)  
 
 
Time for 
session: 30 
minutes 
 
 
 
Phase 1: The participant will place the goals (dietary and physical activity) into their “Lose-
It” app via smartphone for goal attainment. 
Phase 2: The participant and the RA will review the electronic report generated from the 
“Lose-It” app for monitoring or assessing progress for dietary intake and physical activity 
each week from baseline to week 12.  
Phase 3: The RA will review with the participant each week for 12 weeks how many days 
they implemented and achieved the solution for their daily goals.  
Phase 4: Time will be allowed for any questions. 
 

  
 
 Risk and Benefits 
The risks for harm to you for participating in this study are minimal. You may feel uncomfortable about 
having the research team knowing about your dietary intake or physical activity level. It is not unusual for 
people with a transplant to occasionally have difficulty with being physical active and controlling their 
weight. We are trying to help people with these common problems. 
 
If you agree to take part in this study, there may or may not be direct medical benefits to you.  
We hope the information learned from this study will in the future benefit other patients with a kidney 
transplant who are having difficulty becoming physically active and assessing their dietary intake. 
E. Internal Validity 
In the previous K award22 study, we found that the primary reason for participants not enrolling 
(65%) into the study was due to the distance of traveling to the research site. Thus, there is a need to 
deliver the intervention activities in home settings via Zoom. The delivery of our study research 
activities is timely due to the Coronavirus (COVID-19) and the fact that our population is 
immunocompromised. Due to the recent pandemic outbreak of the coronavirus (COVID-19) and 
since our population is immunocompromised. We will promote sustainability for participating in the 
study by sending weekly text messages to the participants to thank them for their participation in the 
study. The conduct of this feasibility study will help identify other limitations to consider for future 
studies in a larger multisite clinical trial. We will collect data regarding the time spent on delivering 
the intervention so that we can conduct a cost-effective analysis at a later date.  
 
F. Data Analysis 
Descriptive statistics will be used to summarize sample characteristics. Aim 1) percent approached, 
percent dropped, and percent to adhere to logging daily dietary and physical activity will be analyzed 
using means and standard deviations of these variables and analyzed as differences between the 
baseline and 3-month measurements using the Wilcoxon Signed-Ranked test. Aim 2) Perceived 
Stress Scale, Exercise Self-efficacy Scale, Fruit, Vegetables, and Fiber Screener, fat intake, 
carbohydrate intake, weight, blood pressure, heart rate, and the minutes of physical activity per day 
will be analyzed using the differences among  baseline, 4,8, and 12 weeks using repeated measures 
analysis of variance using the Friedman's Test. Frailty levels will be collected at baseline and 12 
weeks and will be analyzed using means and standard deviations of this variables. Missing Data: We 
will carefully record and code various reasons for missing data (e.g., participants forget to record data 
into the “Lose-It” app) and examine the pattern of missing data. 
 
 
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