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

NCT05592288 | Completed

• 1 other identifier: TDK-2022-6085
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus Risk; PreDiabetes

Keywords

Diabetes Mellitus Risk; PreDiabetes; Mobile application; Physical activity; Mediterranean Diet; Metabolic variables

Outcome Measures

Primary Outcomes (4)

• Mediterranean Diet Adherence Screener-MEDAS)

  The Turkish validity and reliability studies for MEDAS.

  Change 6 months from baseline

• International Physical Activity Questionnaire (IPAQ)

  The IPAQ International Physical Activity Questionnaire-Short Form.

  Change 6 months from baseline

• 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.

  Change 6 months from baseline

• 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.

  Change 6 months from baseline

Secondary Outcomes (5)

• Height-Weight Measurement and Body Mass Index

  Change 6 months from baseline

• Mobile App Usability and Usage Assessment Scale

  6th month

• Mobile Application Usability Scale

  6th month

• Continued Intention to Use Scale

  6th month

• Brand Loyalty Scale

  6th month

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Control grup

NO INTERVENTION

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.)

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University

Antalya, City Center, 07000, Turkey (Türkiye)

Location

Related Publications (14)

• 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).

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 14633807 BACKGROUND

• 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.

  PMID: 18511765 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 26499966 BACKGROUND

• 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.

  PMID: 32886192 BACKGROUND

• 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.

  PMID: 32459631 BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 31862745 BACKGROUND

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

  BACKGROUND

• 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.

  BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Prediabetic State; Motor Activity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Officials

• İbrahim Topuz, PhD

  Akdeniz University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-blind (participant)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer (PhD student)

Model Details: 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.

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 24, 2022
• Study Start: March 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: September 1, 2024
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: June 2023
• 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.

Locations

TU (1)