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Diabetes Mellitus RiskMobileAppNCT05592288

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

A study testing PREDIABE-TR mobile app. in people with Diabetes Mellitus Risk and PreDiabetes, run by Akdeniz University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 45 to 65 years
Conditions the study is for
Diabetes Mellitus Risk, PreDiabetes
What is being tested?
PREDIABE-TR mobile app.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Mar 2024to 1 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Akdeniz University

    Antalya, City Center, 07000

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read more

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.

Read the 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.

Being tested
PREDIABE-TR mobile app.
Keywords
Diabetes Mellitus Risk, PreDiabetes, Mobile application, Physical activity, Mediterranean Diet, Metabolic variables
Medical subject headings
Prediabetic State, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PREDIABE-TR mobile app.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.
Study groups in NCT05592288
Study groupRoleWhat they receive
Intervention groupExperimentalThe 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).
Receives: Other: PREDIABE-TR mobile app.
Control grupNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Mediterranean Diet Adherence Screener-MEDAS)

    The Turkish validity and reliability studies for MEDAS.

    Measured: Change 6 months from baseline

  2. International Physical Activity Questionnaire (IPAQ)

    The IPAQ International Physical Activity Questionnaire-Short Form.

    Measured: Change 6 months from baseline

  3. Metabolic Measurements

    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.

    Measured: Change 6 months from baseline

  4. Blood Glucose Measurement

    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.

    Measured: Change 6 months from baseline

Secondary outcomes (5)

  1. 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).

    Measured: Change 6 months from baseline

  2. Mobile App Usability and Usage Assessment Scale

    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.

    Measured: 6th month

  3. Mobile Application Usability Scale

    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.

    Measured: 6th month

  4. Continued Intention to Use Scale

    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.

    Measured: 6th month

  5. Brand Loyalty Scale

    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.

    Measured: 6th month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2022
  2. Study start1 Mar 2024
  3. Primary completion1 Aug 2024
  4. Study completion1 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Participant
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05592288
Sponsor's protocol ID
TDK-2022-6085
Acronym
MobileApp
Status last verified
Mar 2025
First submitted
20 Oct 2022
Last updated
21 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Study Protocol

Publications

  • Etbaş Demirağ H. Diabetes Risk Assessment in First Degree Relatives of Patients with Type-2 Diabetes Mellitus. T.C Adnan Menderes University Instıtute of Health Sciences, Master Thesis, 2016, Aydın, Turkey (Supervision: Prof. Dr. S Boyraz, Doç. Dr. E Ünsal Avdal).

  • Turkish Society of Endocrinology and Metabolism (TEMD). Diagnosis, Treatment and Follow-up Guide for Diabetes Mellitus Complications. 14th Edition. Ankara: Bayt Publication; 2020. ISBN 978-605-4011-40-7.

  • Lindstrom J, Louheranta A, Mannelin M, Rastas M, Salminen V, Eriksson J, Uusitupa M, Tuomilehto J; Finnish Diabetes Prevention Study Group. The Finnish Diabetes Prevention Study (DPS): Lifestyle intervention and 3-year results on diet and physical activity. Diabetes Care. 2003 Dec;26(12):3230-6. doi: 10.2337/diacare.26.12.3230.

    PubMed 14633807

  • Martinez-Gonzalez MA, de la Fuente-Arrillaga C, Nunez-Cordoba JM, Basterra-Gortari FJ, Beunza JJ, Vazquez Z, Benito S, Tortosa A, Bes-Rastrollo M. Adherence to Mediterranean diet and risk of developing diabetes: prospective cohort study. BMJ. 2008 Jun 14;336(7657):1348-51. doi: 10.1136/bmj.39561.501007.BE. Epub 2008 May 29.

    PubMed 18511765

  • Özkan Pehlivanoğlu EF, Balcıoğlu H, Ünlüoğlu İ. The validity and reliability of the adaptation of the Mediterranean Diet Adherence Scale into Turkish. Osmangazi Medical Journal. 2020;42(2): 160-164.

  • Block G, Azar KM, Romanelli RJ, Block TJ, Hopkins D, Carpenter HA, Dolginsky MS, Hudes ML, Palaniappan LP, Block CH. Diabetes Prevention and Weight Loss with a Fully Automated Behavioral Intervention by Email, Web, and Mobile Phone: A Randomized Controlled Trial Among Persons with Prediabetes. J Med Internet Res. 2015 Oct 23;17(10):e240. doi: 10.2196/jmir.4897.

    PubMed 26499966

  • McLeod M, Stanley J, Signal V, Stairmand J, Thompson D, Henderson K, Davies C, Krebs J, Dowell A, Grainger R, Sarfati D. Impact of a comprehensive digital health programme on HbA1c and weight after 12 months for people with diabetes and prediabetes: a randomised controlled trial. Diabetologia. 2020 Dec;63(12):2559-2570. doi: 10.1007/s00125-020-05261-x. Epub 2020 Sep 4.

    PubMed 32886192

  • Toro-Ramos T, Michaelides A, Anton M, Karim Z, Kang-Oh L, Argyrou C, Loukaidou E, Charitou MM, Sze W, Miller JD. Mobile Delivery of the Diabetes Prevention Program in People With Prediabetes: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Jul 8;8(7):e17842. doi: 10.2196/17842.

    PubMed 32459631

  • Turkish Society of Endocrinology and Metabolism. (2018). Diagnosis, Treatment and Follow-up Guidelines for Diabetes Mellitus Complications, 2018.

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

  • American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2020. Diabetes Care. 2020 Jan;43(Suppl 1):S14-S31. doi: 10.2337/dc20-S002.

    PubMed 31862745

  • Turkish Society of Endocrinology and Metabolism. Obesity Diagnosis and Treatment Guide. Ankara: Miki; 2019. ISBN: 978-605-4011-31-5.

  • Hoehle H, Aljafari R, Venkatesh V. Leveraging Microsoft׳ s mobile usability guidelines: Conceptualizing and developing scales for mobile application usability. Int J Hum Comput Stud. 2016;89: 35-53.

  • Güler Ç. A structural equation model to examine mobile application usability and use. International Journal of Informatics Technologies, 2019;12(3): 169-181.

Questions about this trial

What is this clinical trial studying?

A study testing PREDIABE-TR mobile app. in people with Diabetes Mellitus Risk and PreDiabetes, run by Akdeniz University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mediterranean Diet Adherence Screener-MEDAS) (time frame: Change 6 months from baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05592288, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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