Clinical trial NCT05592288: The Impact of a Mobile Application Designed for Adults at Risk of Developing Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Risk
PreDiabetes
Keywords: Diabetes Mellitus Risk
PreDiabetes
Mobile application
Physical activity
Mediterranean Diet
Metabolic variables
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2022-10-24
Enrollment: 61
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Mediterranean Diet Adherence Screener-MEDAS)
timeFrame: Change 6 months from baseline
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: Change 6 months from baseline
measure: Metabolic Measurements
timeFrame: Change 6 months from baseline
measure: Blood Glucose Measurement
timeFrame: Change 6 months from baseline
Secondary outcomes:
measure: Height-Weight Measurement and Body Mass Index
timeFrame: Change 6 months from baseline
measure: Mobile App Usability and Usage Assessment Scale
timeFrame: 6th month
measure: Mobile Application Usability Scale
timeFrame: 6th month
measure: Continued Intention to Use Scale
timeFrame: 6th month
measure: Brand Loyalty Scale
timeFrame: 6th month
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University
state: City Center
Study officials:
affiliation: Akdeniz University
name: İbrahim Topuz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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).
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Turkish Society of Endocrinology and Metabolism. (2018). Diagnosis, Treatment and Follow-up Guidelines for Diabetes Mellitus Complications, 2018.
citation: Roche Diagnostics Türkiye. Accu-Chek Performa Nano. Available from: www.rochediagnotics.com.tr.
citation: 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.
citation: Turkish Society of Endocrinology and Metabolism. Obesity Diagnosis and Treatment Guide. Ankara: Miki; 2019. ISBN: 978-605-4011-31-5.
citation: 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.
citation: Güler Ç. A structural equation model to examine mobile application usability and use. International Journal of Informatics Technologies, 2019;12(3): 169-181.