NCT04894279

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2021

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2022

Completed
Last Updated

March 11, 2022

Status Verified

May 1, 2021

Enrollment Period

9 months

First QC Date

May 16, 2021

Last Update Submit

March 10, 2022

Conditions

Keywords

Covid-19, pandemic, lifestyle

Outcome Measures

Primary Outcomes (3)

  • Short Multidimensional Inventory Lifestyle Evaluation - Confinement

    Questionnaire

    5 minutes

  • Health Promoting Life-Style Profile

    Questionnaire

    10 minutes

  • International Physical Activity Questionnaire - Short Form

    Quesitonnaire

    5 minutes

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

healthy people between 18-65 years old.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Berivan Beril KILIÇ

Istanbul, Turkey (Türkiye)

Location

Related Publications (11)

  • 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.

    PMID: 32962948BACKGROUND
  • 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.

    PMID: 31507466BACKGROUND
  • 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.

    PMID: 32457556BACKGROUND
  • 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.

    PMID: 32248989BACKGROUND
  • 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.

    PMID: 32270698BACKGROUND
  • 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.

    PMID: 19448522BACKGROUND
  • 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.

    PMID: 34908972BACKGROUND
  • 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.

    PMID: 30496105BACKGROUND
  • Tabachnick, B. G., & Fidell, L. S. (2018). Using multivariate statistics (7th ed.).

    BACKGROUND
  • 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.

    BACKGROUND
  • 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

    BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2021

First Posted

May 20, 2021

Study Start

April 30, 2021

Primary Completion

February 1, 2022

Study Completion

February 20, 2022

Last Updated

March 11, 2022

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations