TARUS: The Ariel University Survey on Dietary Changes and Anxiety During the Coronavirus Pandemic

Sponsor
Ariel University (Other)
Overall Status
Completed
CT.gov ID
NCT04353934
Collaborator
(none)
3,797
1
14
271.3

Study Details

Study Description

Brief Summary

Background/Objectives: Psychological anxiety has been associated with alterations in eating patterns. The 2020 global coronavirus pandemic has created a situation characterized by increased anxiety. The present international survey was designed to examine associations between exposure to quarantine/isolation measures, anxiety levels and changes in dietary patterns.

Methods: The present study utilizes a Google Survey platform to conduct an international survey querrying dietary patterns before vs. after the coronavirus pandemic; anxiety during the pandemic; and demographic characteristics. The nutrition portion of the survey is based on the Mediterranean Diet Score while the anxiety estimate is based on the GAD-7. The survey is available in English, Hebrew, Spanish, Italian, French, Arabic and Russian. It has been distributed via social media.

Anticipated Results: We believe that changes in dietary habits will be identified and that these will be associated with anxiety levels. Additionally, we believe that by-country differences will be identified.

Discussion: The Google Survey format distributed by social media provides an almost immediate means of distributing the survey globally. The survey can only be completed if the respondent first indicates his/her informed consent. The convenience sample limits generalizability to individuals who volunteer to complete online surveys; however, we anticipate a large response which may mitigate this limitation.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The study will leverage the COVID-19 pandemic to study associations between dietary patterns, weight changes and anxiety.

    The study utilizes an online survey, publicized on public and personal social media pages, to query demographics, dietary and exercise patterns and measures of anxiety. Dietary patterns are assessed using the Mediterranean Diet Score, which evaluates the similarity between reported dietary intake and the Mediterranen Diet Pattern, which has been shown to reduce all-cause mortality and cardiovascular morbidity and mortality. Changes in dietary patterns and duration of exercise during vs. prior to the pandemic are measured. Anxiety is measured using the General Anxiety Disorder (GAD)-7 scale. Additional measures of social isolation, both prior to and during the pandemic, are queried in the survey. Data are anonymous and investigators have no ability to associated the response to an individual or IP address. However, interested respondents can provide an email address to which an analysis of the diet score can be sent. Data are automatically downloaded to an Excel spreadsheet, and this is cleaned and uploaded to SPSS for analysis. Continuous data are assessed for normality using the Kolmogorov-Smirnov test and will be summarized using median (IQ range) or mean (sd) as appropriate. Nominal data will be summarized in frequency tables and presented as n (%). Associations between the total Mediterranean Diet Score and the GAD-7 will be described by calculating the Pearson's or Spearman's correlation coefficient as appropriate. Before vs. after responses will be evaluated using the Wilcoxon Signed Ranks Test or the McNemar Test. Differences in responses by demographic characteristics will be measured using the t-test for independent samples, the Mann-Whitney U or ANOVA as appropriate. The GAD-7 score will be dichotomized to moderate anxiety or more (GAD-7=10) vs. lower, and modeled using logistic regression analyisis.

    The survey format permits real time response to the ongoing pandemic and the multi-lingual presentation allows for a wide potential population of respondents who can reply in a language in which they are comfortable. Further, this permits by-language comparisons.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    3797 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    The Ariel University Survey on Dietary Changes and Anxiety During the Coronavirus Pandemic: TARUS
    Actual Study Start Date :
    Mar 31, 2020
    Actual Primary Completion Date :
    May 1, 2021
    Actual Study Completion Date :
    May 31, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Respondents

    All adults aged 18 or older who elect to respond to the online survey

    Outcome Measures

    Primary Outcome Measures

    1. The association between Mediterranean Diet Score and Anxiety Score [through study completion, average six months]

      The Mediterranean Diet Score (MedDiet Score) will be calculated and correlated to the Anxiety Score (GAD-7)

    2. The degree to which current dietary intake is consisten with the Mediterranean Diet [through study completion, average six months]

      Mediterranean Diet Score (MedDiet) will be calculated

    Secondary Outcome Measures

    1. By-country comparisons of the association between Mediterranean Diet (MedDiet) score and Anxiety [through study completion, average six months]

      By-country comparisons of the association between Mediterranean Diet (MedDiet) score and Anxiety (GAD-7)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    Inclusion Criteria: All adult individuals (aged 18 or older) who see and elect to respond to the survey will be included.

    -

    Exclusion Criteria: Subjects who indicate that their age is younger than 18 years, and those who do not provide informed consent will be excluded.

    -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ariel University Ariel Israel 4070000

    Sponsors and Collaborators

    • Ariel University

    Investigators

    • Principal Investigator: Mona Boaz, RD, PhD, Department of Nutrition Sciences, Ariel University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Ariel University
    ClinicalTrials.gov Identifier:
    NCT04353934
    Other Study ID Numbers:
    • AU-HEA-VKS-20200329
    First Posted:
    Apr 21, 2020
    Last Update Posted:
    Oct 15, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ariel University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 15, 2021