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

Anxiety Clinical Trial

— TARUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04353934
• Other study ID #: AU-HEA-VKS-20200329
• Status: Completed
• Start date: March 31, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: October 2021
• Source: Ariel University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3797
• Est. completion date: May 31, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

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Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Coronavirus Infections
• Dietary Habits

Locations

Country	Name	City	State
Israel	Ariel University	Ariel

Sponsors (1)

Lead Sponsor	Collaborator
Ariel University

Country where clinical trial is conducted

Israel, 

References & Publications (2)

Abu-Saad K, Endevelt R, Goldsmith R, Shimony T, Nitsan L, Shahar DR, Keinan-Boker L, Ziv A, Kalter-Leibovici O. Adaptation and predictive utility of a Mediterranean diet screener score. Clin Nutr. 2019 Dec;38(6):2928-2935. doi: 10.1016/j.clnu.2018.12.034. Epub 2019 Jan 5. — View Citation

Esser P, Hartung TJ, Friedrich M, Johansen C, Wittchen HU, Faller H, Koch U, Härter M, Keller M, Schulz H, Wegscheider K, Weis J, Mehnert A. The Generalized Anxiety Disorder Screener (GAD-7) and the anxiety module of the Hospital and Depression Scale (HADS-A) as screening tools for generalized anxiety disorder among cancer patients. Psychooncology. 2018 Jun;27(6):1509-1516. doi: 10.1002/pon.4681. Epub 2018 Mar 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The association between Mediterranean Diet Score and Anxiety Score	The Mediterranean Diet Score (MedDiet Score) will be calculated and correlated to the Anxiety Score (GAD-7)	through study completion, average six months
Primary	The degree to which current dietary intake is consisten with the Mediterranean Diet	Mediterranean Diet Score (MedDiet) will be calculated	through study completion, average six months
Secondary	By-country comparisons of the association between Mediterranean Diet (MedDiet) score and Anxiety	By-country comparisons of the association between Mediterranean Diet (MedDiet) score and Anxiety (GAD-7)	through study completion, average six months

External Links

•   Survey page