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Covid19SMİLE-CNCT04894279

Reliability and Validity of the Turkish Version of SMİLE-C

An observational study of Covid19, run by Marmara 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

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). Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Covid19
How many people
166 participants
Where
1 siteTurkey (Türkiye)
Study dates
30 Apr 2021to 20 Feb 2022
Phase
Observational
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 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: healthy people between 18-65 years old.

Who may be able to join

  • Female and male participants aged 18-65, Volunteering to participate in research

Who cannot join

  • Inability to use a computer, tablet or mobile phone, Not answering all the questions in questionnaire

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Berivan Beril KILIÇ

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: A Study of the Reliability and Validity of the Turkish Version of Short Multidimensional Inventory Lifestyle Evaluation - Confinement

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.

Conditions
Covid19
Keywords
Covid-19, pandemic, lifestyle
Medical subject headings
COVID-19

What is being measured

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

  1. Short Multidimensional Inventory Lifestyle Evaluation - Confinement

    Questionnaire

    Measured: 5 minutes

  2. Health Promoting Life-Style Profile

    Questionnaire

    Measured: 10 minutes

  3. International Physical Activity Questionnaire - Short Form

    Quesitonnaire

    Measured: 5 minutes

Timeline

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

  1. First posted20 May 2021
  2. Study start30 Apr 2021
  3. Primary completion1 Feb 2022
  4. Study completion20 Feb 2022

Resources

More details

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

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
166 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04894279
Sponsor's protocol ID
SMİLE-C
Acronym
SMİLE-C
Status last verified
May 2021
First submitted
16 May 2021
Last updated
11 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Balanza-Martinez 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.

    PubMed 32962948

  • Firth J, Ward PB, Stubbs B. Editorial: Lifestyle Psychiatry. Front Psychiatry. 2019 Aug 26;10:597. doi: 10.3389/fpsyt.2019.00597. eCollection 2019. No abstract available.

    PubMed 31507466

  • 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.

    PubMed 32457556

  • 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. No abstract available.

    PubMed 32248989

  • 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. No abstract available.

    PubMed 32270698

  • 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.

    PubMed 19448522

  • Orru 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.

    PubMed 34908972

  • 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.

    PubMed 30496105

  • 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.

  • Yılmaz, Ö , Boz, H , Arslan, A . (2017). DEPRESYON ANKSİYETE STRES ÖLÇEĞİNİN(DASS 21) TÜRKÇE KISA FORMUNUN GEÇERLİLİK-GÜVENİLİRLİK ÇALIŞMASI . Finans Ekonomi ve Sosyal Araştırmalar Dergisi , 2 (2) , 78-91 . Retrieved from. https://dergipark.org.tr/tr/pub/fesa/issue/30912/323190

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19, run by Marmara 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 1 inclusion and 1 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 11 Mar 2022. 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?

Short Multidimensional Inventory Lifestyle Evaluation - Confinement (time frame: 5 minutes). The study lists 3 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 NCT04894279, which also lists 11 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 11 Mar 2022.

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