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

Akdeniz University

Status: Completed

Conditions: Diabetes Mellitus Risk; PreDiabetes

Treatments: Other: PREDIABE-TR mobile app.

Study type: Interventional

Funder types: Other

Identifiers

NCT05592288

TDK-2022-6085

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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61 participants in 2 patient groups

Intervention group

Experimental group

Description:

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).

Treatment:

Other: PREDIABE-TR mobile app.

Control grup

No Intervention group

Description:

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.)