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

NCT ID: NCT05592288

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2024-09-01

Brief Summary

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.

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.

Conditions

Diabetes Mellitus Risk; PreDiabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

PREDIABE-TR mobile app.

Intervention Type: OTHER

• 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.

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.)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akdeniz University

OTHER

Sponsor Role: lead

Responsible Party

İbrahim TOPUZ

Lecturer (PhD student)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

İbrahim Topuz, PhD

Role: PRINCIPAL_INVESTIGATOR

Akdeniz University

Locations

Akdeniz University

Antalya, City Center, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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Roche Diagnostics Türkiye. Accu-Chek Performa Nano. Available from: www.rochediagnotics.com.tr.

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

TDK-2022-6085

Identifier Type: -

Identifier Source: org_study_id