Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2025-12-26 @ 1:12 AM
Study NCT ID:
NCT04353934
Status:
COMPLETED
Last Update Posted:
2021-10-15
First Post:
2020-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Ariel University Survey on Dietary Changes and Anxiety During the Coronavirus Pandemic
Sponsor:
Ariel University
Organization:
Study Overview
Official Title:
The Ariel University Survey on Dietary Changes and Anxiety During the Coronavirus Pandemic: TARUS
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TARUS
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.
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: