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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04894279
Other study ID # SMILE-C
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 30, 2021
Est. completion date February 20, 2022

Study information

Verified date May 2021
Source Marmara University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

How the life style changed multidimensionally with home isolation in the period of COVID-19 is a new research question. Physical and social isolation, home isolation, and quarantine policies applied during epidemic periods such as SARS, MERS, Ebola have been associated with lifestyle changes (Lippi, 2019). Much of the research on the health impact of epidemics and isolation has focused on psychological issues such as stress-related symptoms and disorders and to a lesser extent social support and stress management. In contrast, the epidemic and its associated lifestyle issues during quarantine and isolation, including the impact of dietary changes, restricted physical activity, and increased indoor and screen time, are still not investigated. A limited number of studies have examined lifestyle changes during COVID-19 and previous epidemic periods. However, there is no Turkish survey that comprehensively deals with the lifestyle, the scope of which is expanding, today. The Brief Multidimensional Lifestyle Assessment Scale, which we planned to validate in our study, is a scale developed by Balanzá-Martínez et al to multi-dimensionally evaluate the lifestyle changes that occurred during the COVID-19 outbreak. It consists of 7 parts (Diet and Nutrition, Substance addiction, Physical activity, Stress management, Restorative sleep, Social support and Environmental exposure) and a total of 27 items. There are response options measured using a 4-point Likert scale. High scores indicate a healthy lifestyle (Balanzá-Martínez, 2021). In this context, we think that adapting the Short Multidimensional Lifestyle Assessment Scale / Short Multidimensional Inventory Lifestyle Evaluation - Confinement (SMILE-C) questionnaire into Turkish will make a significant contribution to the literature.


Recruitment information / eligibility

Status Completed
Enrollment 166
Est. completion date February 20, 2022
Est. primary completion date February 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: Female and male participants aged 18-65, Volunteering to participate in research Exclusion Criteria: Inability to use a computer, tablet or mobile phone, Not answering all the questions in questionnaire

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Berivan Beril KILIÇ I?stanbul

Sponsors (1)

Lead Sponsor Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (11)

Balanzá-Martínez V, Kapczinski F, de Azevedo Cardoso T, Atienza-Carbonell B, Rosa AR, Mota JC, De Boni RB. The assessment of lifestyle changes during the COVID-19 pandemic using a multidimensional scale. Rev Psiquiatr Salud Ment (Engl Ed). 2021 Jan-Mar;14(1):16-26. doi: 10.1016/j.rpsm.2020.07.003. Epub 2020 Aug 29. English, Spanish. — View Citation

Firth J, Ward PB, Stubbs B. Editorial: Lifestyle Psychiatry. Front Psychiatry. 2019 Aug 26;10:597. doi: 10.3389/fpsyt.2019.00597. eCollection 2019. — View Citation

GBD 2017 Risk Factor Collaborators. Global, regional, and national comparative risk assessment of 84 behavioural, environmental and occupational, and metabolic risks or clusters of risks for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1923-1994. doi: 10.1016/S0140-6736(18)32225-6. Epub 2018 Nov 8. Erratum in: Lancet. 2019 Jan 12;393(10167):132. Lancet. 2019 Jun 22;393(10190):e44. — View Citation

He H, Harris L. The impact of Covid-19 pandemic on corporate social responsibility and marketing philosophy. J Bus Res. 2020 Aug;116:176-182. doi: 10.1016/j.jbusres.2020.05.030. Epub 2020 May 21. — View Citation

Jiao WY, Wang LN, Liu J, Fang SF, Jiao FY, Pettoello-Mantovani M, Somekh E. Behavioral and Emotional Disorders in Children during the COVID-19 Epidemic. J Pediatr. 2020 Jun;221:264-266.e1. doi: 10.1016/j.jpeds.2020.03.013. Epub 2020 Apr 3. — View Citation

Lippi G, Henry BM, Sanchis-Gomar F. Physical inactivity and cardiovascular disease at the time of coronavirus disease 2019 (COVID-19). Eur J Prev Cardiol. 2020 Jun;27(9):906-908. doi: 10.1177/2047487320916823. Epub 2020 Apr 9. — View Citation

Orrù G, Ciacchini R, Gemignani A, Conversano C. Psychological Intervention Measures During the Covid-19 Pandemic. Clin Neuropsychiatry. 2020 Apr;17(2):76-79. doi: 10.36131/CN20200208. — View Citation

Pinar R, Celik R, Bahcecik N. Reliability and construct validity of the Health-Promoting Lifestyle Profile II in an adult Turkish population. Nurs Res. 2009 May-Jun;58(3):184-93. doi: 10.1097/NNR.0b013e31819a8248. — View Citation

Tabachnick, B. G., & Fidell, L. S. (2018). Using multivariate statistics (7th ed.).

Walker, S. N., & Hill-Polerecky, D. M. (1997). Psychometric evaluation of Health Promoting Lifestyle Profile II. Unpublished manuscript, University of Nebraska Medical Center, College of Nursing, Lincoln.

Yilmaz, Ö , Boz, H , Arslan, A . (2017). DEPRESYON ANKSIYETE STRES ÖLÇEGININ(DASS 21) TÜRKÇE KISA FORMUNUN GEÇERLILIK-GÜVENILIRLIK ÇALISMASI . Finans Ekonomi ve Sosyal Arastirmalar Dergisi , 2 (2) , 78-91 . Retrieved from. https://dergipark.org.tr/tr/pub/fesa/issue/30912/323190

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Short Multidimensional Inventory Lifestyle Evaluation - Confinement Questionnaire 5 minutes
Primary Health Promoting Life-Style Profile Questionnaire 10 minutes
Primary International Physical Activity Questionnaire - Short Form Quesitonnaire 5 minutes
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