The Impact of a Mobile Application Designed for Adults at Risk of Developing Diabetes (MobileApp)

March 20, 2025 updated by: İbrahim TOPUZ, 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

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. Statistical data will be analyzed using the Statistical Package for the Social Sciences 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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hypotheses

Our hypotheses were formulated in line with 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, Impaired Glucose Tolerance 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.

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • City Center
      • Antalya, City Center, Turkey, 07000
        • Akdeniz University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria

  • Individuals to be included will be those who: are prediabetic (Impaired Fasting Glucose =100-125 mg/dl-mmol/L, A1C=5.7%-6.4% or Impaired Glucose Tolerance=140-190 mg/dl-mmol/L),
  • are active Android/phone operating system 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
The study universe will consist of adults of the ages 45-65 who have received a diagnosis of prediabetes and are registered at the Family Health Center No. 9. PREDIABE-TR mobile app usage (six months).
Other: PREDIABE-TR mobile app.
  • 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.
  • Module 3: Healthy lifestyle behaviors The sub-sections of the module are devoted to nutrition, height-weight-body mass index (BMI) and physical activity.
No Intervention: Control grup
The study universe will consist of adults of the ages 45-65 who have received a diagnosis of prediabetes and are registered at the Family Health Center No. 9. Routine practice (Brochures of the Public Health Directorate, Mobile apps of the Ministry of Health, etc.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mediterranean Diet Adherence Screener-MEDAS)
Time Frame: Change 6 months from baseline
The Turkish validity and reliability studies for MEDAS.
Change 6 months from baseline
International Physical Activity Questionnaire (IPAQ)
Time Frame: Change 6 months from baseline
The IPAQ International Physical Activity Questionnaire-Short Form.
Change 6 months from baseline
Metabolic Measurements
Time Frame: Change 6 months from baseline
The participants' A1C, fasting blood glucose values will be measured. The A1C Measurement represents a 3-month mean value The A1C testing does not require fasting conditions. The blood sample can be taken at any time of day. 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.
Change 6 months from baseline
Blood Glucose Measurement
Time Frame: Change 6 months from baseline
The researcher will measure the participants' blood glucose with a Roche Accu-Chek® perform nano device. A minimum eight-hour fasting period will be taken as a criterion for fasting blood glucose; a postprandial blood glucose test will be administered 2 hours after a meal.
Change 6 months from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Height-Weight Measurement and Body Mass Index
Time Frame: Change 6 months from baseline
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).
Change 6 months from baseline
Mobile App Usability and Usage Assessment Scale
Time Frame: 6th month
Three measures developed before to assess the usability and usage of a mobile application will be used. The validity and reliability study for the scales was performed for Turkish.
6th month
Mobile Application Usability Scale
Time Frame: 6th month
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.
6th month
Continued Intention to Use Scale
Time Frame: 6th month
This measurement tool was developed to assess how eager individuals are to use the app. 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.
6th month
Brand Loyalty Scale
Time Frame: 6th month
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.
6th month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akdeniz University

Investigators

  • Principal Investigator: İbrahim Topuz, PhD, Akdeniz University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Actual)

August 1, 2024

Study Completion (Actual)

September 1, 2024

Study Registration Dates

First Submitted

October 20, 2022

First Submitted That Met QC Criteria

October 20, 2022

First Posted (Actual)

October 24, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 20, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TDK-2022-6085

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Protocol

IPD Sharing Time Frame

June 2023

IPD Sharing Access Criteria

When this study protocol is published as an article, the link will be shared. Statistical Analysis Plan will be included in the article. The Informed Consent Form will be stored by the primary investigator. It can be requested from the researcher.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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