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临床试验/NCT04353934
NCT04353934已完成不适用

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

Ariel University1 个研究点 分布在 1 个国家目标入组 3,797 人开始时间: 2020年3月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3,797
试验地点
1
主要终点
The association between Mediterranean Diet Score and Anxiety Score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

The association between Mediterranean Diet Score and Anxiety Score

时间窗: through study completion, average six months

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

The degree to which current dietary intake is consisten with the Mediterranean Diet

时间窗: through study completion, average six months

Mediterranean Diet Score (MedDiet) will be calculated

次要结局

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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