The Impact of a Mobile Application Designed for Adults at Risk of Developing Diabetes
- Conditions
- Diabetes Mellitus RiskPreDiabetes
- Interventions
- Other: PREDIABE-TR mobile app.
- Registration Number
- NCT05592288
- Lead Sponsor
- Akdeniz University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group PREDIABE-TR mobile app. 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).
- Primary Outcome Measures
Name Time Method Mediterranean Diet Adherence Screener-MEDAS) Change 6 months from baseline The Turkish validity and reliability studies for MEDAS.
Metabolic Measurements 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.
International Physical Activity Questionnaire (IPAQ) Change 6 months from baseline The IPAQ International Physical Activity Questionnaire-Short Form.
Blood Glucose Measurement 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.
- Secondary Outcome Measures
Name Time Method Continued Intention to Use Scale 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.
Brand Loyalty Scale 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.
Height-Weight Measurement and Body Mass Index 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).
Mobile Application Usability Scale 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.
Mobile App Usability and Usage Assessment Scale 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.
Trial Locations
- Locations (1)
Akdeniz University
🇹🇷Antalya, City Center, Turkey