The Impact of a Mobile Application Designed for Adults at Risk of Developing Diabetes on Following the Mediterranean Diet Plan, Physical Activity and Metabolic Parameters: a Study Protocol for a Randomized Controlled Trial
Phase: NA
Conditions: Diabetes Mellitus Risk, PreDiabetes
Sponsor: Akdeniz University

The Impact of a Mobile Application Designed for Adults at Risk of Developing 
Diabetes on Following the Mediterranean Diet Plan, Physical Activity and 
Metabolic Parameters: a Study Protocol for a Randomized Controlled Trial  
Abstract 
Aim: The aim of this study is to determine whether a prediabetes mobile application 
(PREDIABE-TR) designed in Turkish to inform and advise individuals at risk of 
developing diabetes about healthy eating and physical exercise can make a difference in 
the participants’ eating according to the Mediterranean Diet Plan, or in their physical 
activity and other diabetes-related metabolic parameters.   
Methods: A total of 120 adults at risk of developing diabetes will be assigned into an 
experimental and a control group by means of Stratified Permuted Block Randomization. 
The adults in the experimental group will be using the PREDIABE-TR mobile application 
for a period of 6 months. Over the same period, the control group will use the Turkish 
Nutrition Guide and the Diabetes Checklists mobile application distributed by the Turkish 
Ministry of Health. At the end of the six-month period, a review will be made of the 
diabetes metabolic data, physical activity levels and the Mediterranean Diet eating 
behaviors. At the same time, an assessment will be made of the control group’s use of the 
mobile application with the help of the Mobile Application Usability Scale (MAUS). 
Statistical data will be analyzed using the SPSS program. 
Discussion: The benefits of interventions to promote a healthy lifestyle are evident in 
terms of preventing a transition from prediabetes to diabetes and maintaining present 
status. The current novel coronavirus (Covid-19) pandemic has clearly shown the 
advantages of and necessity for remote interventions. In this study, we will attempt to 
determine whether or not the use of the PREDIABE-TR mobile application can promote a 
healthy lifestyle and achieve a reduced risk of diabetes. 
Impact: This study will serve to provide evidence of the practicality, acceptability and 
cost effectiveness of various applications (such as mobile apps) that can be an alternative 
to face-to-face consultation and other medical practices. This alternative can be suggested 
to policy- and decision-makers. Such applications can also be considered preventive 
strategies.  
Trial Registration: (ClinicalTrials.gov identifier). 

Protocol version:  
Keywords: Diabetes risk, prediabetes, mobile application, physical activity, 
Mediterranean Diet, metabolic variables. 
 
INTRODUCTION 
The “prediabetic” stage that is the interval leading to manifest diabetes from normal 
glucose metabolism is observed to transition into Type 2 diabetes in 5%-10% of 
individuals each year (Tabak et al., 2012; Turkish Ministry of Health, Türkiye Diabetes 
Program 2015-2020). It was reported in the United States that there were over 88 million 
people with prediabetes in 2020. This means that one out of every three Americans has 
prediabetes. More importantly, eight out of every ten adults are unaware that they have 
prediabetes (Centers for Diseases Control and Prevention-CDC, 2020). The frequency of 
prediabetes is reported in the “Turkish Survey on the Epidemiology of Diabetes” 
(TURDEP-II-2010) as 28.7% (Turkish Ministry of Health, Türkiye Diabetes Program 
2015-2020). It can be seen in Türkiye that in the past 12 years, there has been an increase 
of 106% in prediabetes when compared with the TURDEP-I report (Satman et al., 2013). 
According to TURDEP data, three out of every 10 adults have prediabetes and over time, 
there continues to be a remarkable progressive increase in the number of individuals with 
the condition. 
There are a number of studies that have been conducted in Türkiye assessing various 
complications and variables related to prediabetes (Avishovi, 2019; Demirel, 2019).  We 
found in the accessible resources in the Turkish literature that there are a few studies on 
mobile applications designed to monitor individuals with diabetes (Kılıç, 2018; Orhan, 
2018; Timurtaş, 2019), and others that evaluate the effect of such applications (Kılıç, 
2018; Orhan, 2018), but we have not found any research published on a Turkish mobile 
app for individuals with prediabetes or about the effect of such an app on metabolic 
variables. The aim of this study is to determine whether participants at risk of diabetes 
making use of a prediabetes mobile application (PREDIABE-TR) designed in Turkish to 
inform and advise about healthy eating and physical exercise can record a difference in 

their implementation of the Mediterranean Diet, their engaging in physical activity and in 
other diabetes-related metabolic parameters. 
 
Hypotheses 
Our hypotheses were formulated in line with PICOS (Population-Intervention-
Comparison-Outcome-Study); significance was set at 0.05 (Higgins et al., 2019). In 
addition to standard applications, the intervention group will be using the PREDIABE-TR 
mobile app. The control group will only use standard applications. In this context, our 
research hypotheses are the following: 
H1a: When compared with the control group, the eating behaviors with regard to adopting 
the Mediterranean Diet of prediabetic adults using the PREDIABE-TR app will be at a 
higher level. 
H1b: When compared with the control group, the physical activity (MET, number of 
steps) of prediabetic adults using the PREDIABE-TR app will be at a higher level. 
H1c: When compared with the control group, the metabolic parameters (A1C, Impaired 
Fasting Glucose-IFG, Impaired Glucose Tolerance-IGT) of prediabetic adults using the 
PREDIABE-TR app will be at lower levels. 
H1d: When compared with the control group, prediabetic adults using the PREDIABE-
TR app will lose more weight. 
 
METHODS 
Study design 
This study protocol was drawn up for a single center, single-blind (participant), pretest-
posttest, follow-up, parallel group (1:1 ratio) randomized controlled trial (Fig.1). The 
study protocol was prepared on the basis of the following Standard Protocol Items: 
Recommendations for Interventional Trials (SPIRIT) guidelines (Chan et al., 2013) and 
the Consolidated Standards of Reporting Trials, Non-Pharmacological Treatment 
Interventions Checklist (CONSORT-NPT) (Boutron et al., 2017). The study was 
registered on ClinicalTrials.gov on XXX with the ID XXXX. 

Study setting and population 
This study will be carried out at the Yıldırım Beyazıt Family Health Center (FHC) No. 9, 
a facility in the city of Kutahya, in western Türkiye. No. 9 is an FHC that addresses a large 
city population and where 5 physicians and 5 midwives work. The target sample will 
consist of prediabetic adults. The study will be conducted in the FHC between January 
and July 2023.  
Sample size determination  
The study universe will consist of adults of the ages 45-65 who have received a diagnosis 
of prediabetes and are registered at the Kütahya  FHC No. 9. The sample size determined 
by power analysis is based on calculations made with the G-Power program that were 
used in a similar study. Effect size is 0.666 (Chen et al., 2015, Everett et al., 2018); level 
of significance, 0.05; confidence interval limit 95%; testing power, 90%. The optimal 
number of participants calculated in the two-way hypothesis review was found to be 49 
for each group. In previous studies (Chen et al., 2015; Zhang et al., 2017), the size was 
increased by 10% to allow for losses. Ultimately, the decision was to enroll 60 participants 
in each group. 
Inclusion criteria  
• Individuals to be included will be those who: are prediabetic (Impaired Fasting 
Glucose-IFG=100-125 mg/dl-mmol/L, A1C=5.7%-6.4% or Impaired Glucose 
Tolerance-IGT=140-190 mg/dl-mmol/L), 
• are active Android/IOS cell phone users, 
• are not pregnant or have any malignancy, 
• have no hearing or vision impairment, 
• are at least primary school graduates and fluent in Turkish. 
Exclusion criteria 
• Individuals who have a diagnosis of diabetes or are using an insulin pump or oral 
antidiabetic agents, 
• have vision impairment, 

• are pregnant, 
• have any condition that precludes engaging in physical activity, 
• have psychiatric issues or problems with communicating, will be excluded. 
Randomization 
The stratified block randomization (1:1) will be used to attain objectivity in assigning 
individuals to the experimental group that will be using the mobile app and to the controls 
who will be following routine practices (Brugnara et al., 2016; Kautzky-Willer et al., 
2016; Kautzky-Willer et al., 2019). The variable “gender” will be used as the control 
variable in the stratified block randomization. 
Blinding and Preventing Bias  
The researchers cannot be blinded in this study since they were the parties to develop the 
application and will be involved in the training. On the other hand, the participants can be 
blinded because they are to be using either the PREDIABE-TR app or the Türkiye 
Nutrition Guide. In order to prevent bias, the collection of the randomized assignment data 
will be handled by a researcher who is not actively involved in the study; this researcher 
will submit the data in opaque envelopes to the implementing researcher. 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                  
 
Adults with prediabetes registered with the 
Family Health Center 
Eligible prediabetic adults ages 45-65 
(n=120) 
Metabolic measurements Blood glucose, 
A1C 
A1C= 5.7%-6.4%  
IFG= FPG: 5.6-6.9 mmol/L  
IGT= 7.8-10.5 mmol/L 
Prediabetic adults who 
do not meet eligibility 
(inclusion and 
exclusion criteria)  
Stratified Block Randomization (1:1) 
(n=120). 
Intervention group 
PREDIABE-TR mobile app 
usage (six months).  
Routine practice (Brochures of the 
Public Health Directorate, Mobile 
apps of the Ministry of Health, 
etc.)  
MEDAS  
IPAQ  
Metabolic measurements (A1C, 
fasting blood glucose) 
MAUS, CITUS & BLS. 
Active control group 
Baseline: Pre-
intervention 
measurement (T0) 
MEDAS  
IPAQ  
Metabolic measurements (A1C, 
fasting blood glucose) 
Intention to treat 
Analysis  
3rd month Baseline 
post-intervention 
(T2)  
Metabolic measurements 
(A1C, fasting-postprandial 
blood glucose) 
MEDAS  
IPAQ  
Metabolic measurements (A1C, 
fasting blood glucose) 
Intervention  
6th month:  
Baseline to post-
intervention 
measurement 
(T3) 
Allocation  
Enrollment 

 
Intervention Group  
PREDIABE-TR mobile app group 
Prediabetic individuals 45 years of age and over will be asked to use the PREDIABE-TR 
mobile app. The researcher will demonstrate how the application can be downloaded to 
the participants’ phones and how to use it.  Before the PREDIABE-TR app is sent out to 
the participants, its content will be reviewed for suitability and content validity by health 
professionals and experts in health communications, informatics, and social media. The 
mobile app will be used and the process monitored for a period of 6 months. Each week, 
healthy eating and physical activity messages will be sent over the mobile app and a daily 
step count will be announced.  Education about prediabetes, the risk of diabetes, the 
calculation of the body mass index, as well as other motivating self-evaluation tools and 
notifications will be sent out via the PREDIAB-TR mobile app. The adherence of the 
experimental group to the intervention will be assessed in the software and encouraging 
messages will be sent out to ensure continued use of the app. For example: Bracelets 
inscribed with “Congrats! You’ve reached your daily steps goal!” or “Keep Active, Keep 
Protected from Diabetes!” will be distributed as gifts. If requested, the researcher will 
come to the FHC one day every week to meet with the participants. 
The application consists of a total of 3 parts and 4 modules (Figure 2). 
 
 
 
 
 
 
 
 
Modules 
Personal Data 
Healthy Lifestyle 
Practices 
Communication 
Medical History 
and 
Diabetes Risk 
Notifications 
Safety 
 
Fi
1 P di b
bil
d f

• Module 1: Personal data  
Containing data on the participant’s age, gender, telephone number, email and 
perception of his/her health (bad, so-so, good, very good). 
• Module 2: Medical history of the participant 
In this module, the participants tick the items that apply to themselves or their first-
degree relatives by marking the conditions in their medical history that may 
increase the risk of prediabetes. Additionally, in line with the recommendations of 
the Turkish Association of Endocrinology and Metabolism, this module contains 
the Finnish Diabetes Type-2 Risk Score (FINDRISK) which assesses an 
individual’s risk of diabetes (TEMD, 2020). 
• Module 3: Healthy lifestyle behaviors  
The sub-sections of the module are devoted to nutrition, height-weight-body mass 
index (BMI) and physical activity.  
Nutrition 
Users can enter the foods they eat into the application and are informed of the 
benefit/harm of these foods with a red/green light alert. The weight-to-height risk 
table of the Turkish Diabetes Foundation has been added to the BMI section, where 
additionally, individuals can automatically calculate their BMI according to the 
entered height and weight data (https://www.turkdiab.org/diyabet-hakkinda-
hersey.asp?lang=TR&id=59, Access Date: 9 January 2022). Furthermore, this 
section will also provide users with 14 recommendations from the Mediterranean 
Diet Adherence Screener-MEDAS.  
Physical Activity 
Physical activity will be followed up with a step-count and a scheduling of the 
recommended physical activity the participant should engage in during the week. 
A gold star icon will be sent to app users when they satisfy their physical activity 
requirement. At the end of the study, those who have collected 18 or more gold 
stars will be gifted bracelets inscribed with “Keep Active, Keep Protected from 
Diabetes!” 
Communications  

This module will allow users to send direct messages to the researcher, 24/7 for 
any information they may need. 
Notifications  
This section contains information based on the guidelines of the International 
Diabetes Federation (IDF), the American Diabetes Association (ADA), the 
Turkish Ministry of Health, Association of Turkish Dieticians, the Turkish 
Diabetes Foundation, Turkish Diabetes Society, and the Turkish Diabetes Nursing 
Association on the signs and symptoms of diabetes and prediabetes, diagnosis, 
treatment, complications, nutrition, physical activity, BMI monitoring and the 
normal BMI range. The section is designed to inform users about the content of 
the guidelines and raise awareness and knowledge levels about diabetes. 
Safety  
This section contains the data and passwords users will use to access the system. 
Active Control Group 
Besides the routine health monitoring of the active controls, this group will be instructed 
in how to download and use the Ministry of Health’s Türkiye Nutrition Guide Mobile 
Application.  
Brochures of the Public Health Directorate on healthy nutrition, physical activity, chronic 
illnesses, and screening. 
Data Collection 
 
Data will be collected on the individuals’ sociodemographic features, gender, age, 
education, profession and medications they are taking. Their diabetes risk will be 
measured by means of the Finnish Diabetes Type-2 Risk Score (FINDRISK). The data 
collection form will be filled out on the basis of self-reporting. FINDRISK was developed 
in 1987 by Tuomilehto and Lindström to identify individuals at risk of Type-2 diabetes 
mellitus without laboratory testing (Lindström et al., 2003). The Turkish validity and 
reliability study for FINDRISC was performed by Etbaş Demirağ in 2016 (Etbaş Demirağ, 
2016). The participants’ metabolic measurements will be taken by a researcher using the 

Accu-Chek® Performa Nano device from a capillary blood sample; A1C values will be 
retrieved from FHC records.  
Outcome criteria 
The expected primary outcome is a change in the adherence to the Mediterranean diet, 
physical activity levels and in the prediabetes metabolic values of the adults. The 
secondary outcome is a change in the adults’ ability to achieve weight loss. 
Primary outcome criterion 
Mediterranean Diet Adherence Screener-MEDAS) 
The Turkish validity and reliability studies for MEDAS, which was originally developed 
in 2012 by Martínez-González et al., were performed by Özkan Pehlivanoğlu et al. in 2020 
(Martínez-González et al., 2008; Özkan Pehlivanoğlu et al., 2020). MEDAS consists of 
14 questions (León-Muñoz et al., 2012). Each question is worth 1 or 0 points, depending 
on consumption. A total score of 7 or above indicates that the individual is adhering to the 
Mediterranean diet at an acceptable rate; a score of 9 or above indicates strict adherence. 
Cronbach’s alpha coefficient for the scale is reported to be 0.829. 
International Physical Activity Questionnaire (IPAQ) 
The IPAQ International Physical Activity Questionnaire-Short Form was developed in 
1996 by Booth in order to identify the risk factors of inactivity and physical activity levels 
in prediabetes. The Turkish version of the IPAQ-Short Form consisting of 7 questions will 
be used. The Turkish validity and reliability studies for this questionnaire were conducted 
by Saglam et al. (Öztürk, 2005; Saglam et al., 2010).  
Metabolic Measurements  
The participants’ A1C, fasting blood glucose-postprandial blood glucose (whichever is 
appropriate for the individual) values will be measured.  
The A1C Measurement represents a 3-month mean value (Block et al., 2015; McLeod et 
al., 2020; Toro-Ramos et al., 2020). The A1C testing does not require fasting conditions. 
The blood sample can be taken at any time of day (TEMD, Diabetes Mellitus 
Complications Diagnosis, Treatment and Monitoring Guidelines, 2018). Over the period 

of the study, the A1C result the participant has obtained from being tested at any health 
facility will be taken from the personal health system records.  
Blood Glucose Measurement: The researcher will measure the participants’ blood 
glucose with a Roche Accu-Chek® Performa Nano device (www.rochediagnotics.com.tr, 
Access Date: 4 May 2022). A minimum eight-hour fasting period will be taken as a 
criterion for fasting blood glucose (ADA, 2020); a postprandial blood glucose test will be 
administered 2 hours after a meal.  
 
Secondary outcome criterion 
Height-Weight Measurement and Body Mass Index  
The researcher will measure the individuals’ height and weight with calibrated devices. 
BMI will be calculated with the formula: weight (kg)/height (m2) (TEMD, Obesity 
Diagnosis and Treatment Guidelines, 2019). 
Mobile App Usability and Usage Assessment Scale 
Three measures developed by Hoehle et al. (2016) to assess the usability and usage of a 
mobile application will be used. The validity and reliability study for the scales was 
performed by Güler (2019).  
Mobile Application Usability Scale-MAUS  
This is a measure used to assess and understand how the mobile app can be improved and 
how it may be made more user-friendly. The scale is a 7-point Likert-type and has a total 
of 40 items (1=Definitely disagree, 7=Completely agree). Cronbach’s alpha coefficient 
for the scale is reported as 0.80-0.94 (Güler, 2019). 
Continued Intention to Use Scale-CITUS  
This measure was developed to assess how eager individuals are to use the app. It 
comprises a total of 6 items and is a 7-point Likert-type (1=Definitely disagree, 
7=Completely agree). There are no reversely scored items on the scale. Cronbach’s alpha 
coefficient for the scale is reported as 0.90 (Güler, 2019). 
Brand Loyalty Scale-BLS 

This scale was developed to determine the extent of individuals’ loyalty to the mobile app. 
It comprises a total of 5 items and is a 7-point Likert-type (1=Definitely disagree, 
7=Completely agree). There are no reversely scored items on the scale. Cronbach’s alpha 
coefficient for the scale is reported as 0.86 (Güler, 2019).  
Ethical Considerations in the Study  
Ethical approval for the conduct of the study was obtained from Akdeniz University 
Faculty of Medicine Clinical Studies Ethics Committee (Date: 16.03.2022, No. KAEK-
192) and institutional approval from the Kütahya Provincial Health Directorate (Date: 
30.05.2022, No. 2022/47). Additionally, the written informed consent of the individuals 
to be included in the study will be collected. The study was conducted in compliance with 
the ethical principles of the Declaration of Helsinki. It was registered on ClinicalTrials.gov 
on XXXXX). 
Validity-Reliability 
The study protocol was drawn up based on the SPIRIT (Chan et al., 2013) and CONSORT-
NPT (Boutron et al., 2017) guidelines. Randomization and blinding will reduce bias in the 
results. The measuring instruments used in this study are valid and reliable (Block et al., 
2015; Etbaş Demirağ, 2016; Güler, 2019; McLeod et al., 2020; Özkan Pehlivanoğlu et al., 
2020; Saglam et al., 2010; Toro-Ramos et al., 2020). 
Data Analysis 
The data will be analyzed with the SPSS (Statistical Package for the Social Sciences) 23.0 
package program licensed by Akdeniz University Faculty of Medicine Department of 
Biostatistics.  The G*Power 3.1 program was used in determining sample size. Intention 
to Treat (ITT) analysis will be employed for the analysis of lost data. Descriptive statistics 
will be defined by means and standard deviation. Numbers, percentage distribution, the 
chi-square and t test will be used to identify homogeneous groups. To test normality, 
skewness and kurtosis values will be taken as a basis for the Shapiro-Wilk test. The one-
way ANOVA, two-way ANOVA and ANCOVA tests will be used for dependent and 
independent groups. Non-parametric equivalents of correlation and regression analyses 
will be considered in the non-parametric analysis.  
 

DISCUSSION 
This study will investigate the efficacy of a mobile application developed under the 
leadership of public health nursing staff on metabolic factors such as A1C and on physical 
activity and nutrition. Each message sent to the participants via the app will be evaluated 
on an individual basis. This strategy will have a potential key role in the development of 
healthy lifestyle applications in the long term. The control group will be asked to use the 
Diabetes Checklists and the Turkish Nutrition Guide of the Ministry of Health (Republic 
of Turkiye, Ministry of Health, Public Health Directorate). The experimental group in the 
same study will use the PREDIABE-TR mobile app and the metabolic factors, physical 
activity levels and Mediterranean diet nutritional behaviors of both groups will be 
compared. This course of action was planned in the light of current studies (Abbate et al., 
2021; Fischer et al., 2016; Ramachandran vel al., 2013). 
In the development stage of the mobile app, it was designed for use within the healthcare 
system of the Ministry of Health. Furthermore, it is important that the mobile app will be 
used for a period of six months, which will provide a time frame to determine the 
shortcomings of the app. Since the mobile app is free of charge, it can be used on a wide 
scale by nurses (Abbate et al., 2021). The app can also be considered a facilitating 
alternative to face-to-face examinations, consultations, and follow-ups over the course of 
the current pandemic. It therefore opens the door to early diagnosis for individuals with 
prediabetes. The research is a randomized study of experimental design. The evidential 
level of the results to be obtained will be high. The developed mobile app will 
consequently offer individuals with prediabetes, socially disadvantaged groups, and health 
personnel an instrument that can be conveniently and safely employed. At the end of the 
study, this mobile application will be integrated into the Google Play Store database. 
 
 
 

CONCLUSION 
This study describes the effect of the use of a mobile application by individuals with 
prediabetes on metabolic parameters. If reductions can be achieved in metabolic 
parameters (such as A1C), it can be concluded that the mobile app is effective. In this 
context, information about this application will be sent out to administrators and policy-
makers to ensure that more people make use of the app, thereby supporting communities 
in protecting and improving public health. This study is the first to elaborate on the role 
of public health nurses in prediabetes and preventive health. 
 
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