Dietary HabitsTARUSNCT04353934
The Ariel University Survey on Dietary Changes and Anxiety During the Coronavirus Pandemic
An observational study of Dietary Habits and Anxiety, run by Ariel University at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dietary Habits, Anxiety
- How many people
- 3,797 participants
- Where
- 1 siteIsrael
- Study dates
- 31 Mar 2020to 31 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will include all adult individuals who see and elect to complete the survey online and who provide informed consent by clicking on the appropriate button.
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.
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Ariel University Survey on Dietary Changes and Anxiety During the Coronavirus Pandemic: TARUS
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.
Read more
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.
Read the 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.
- Conditions
- Dietary Habits, Anxiety
- Keywords
- Coronavirus pandemic
- Medical subject headings
- Feeding Behavior, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Respondents | All adults aged 18 or older who elect to respond to the online survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: through study completion, average six months
The degree to which current dietary intake is consisten with the Mediterranean Diet
Mediterranean Diet Score (MedDiet) will be calculated
Measured: through study completion, average six months
Secondary outcomes (1)
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)
Measured: through study completion, average six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start31 Mar 2020
- Primary completion1 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dietary HabitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 3,797 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ariel University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mona Boaz, RD, PhD, Principal investigator, Department of Nutrition Sciences, Ariel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04353934
- Sponsor's protocol ID
- AU-HEA-VKS-20200329
- Acronym
- TARUS
- Status last verified
- Oct 2021
- First submitted
- 12 Apr 2020
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30642736Esser P, Hartung TJ, Friedrich M, Johansen C, Wittchen HU, Faller H, Koch U, Harter 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.
PubMed 29473255Kaufman-Shriqui V, Navarro DA, Raz O, Boaz M. Multinational dietary changes and anxiety during the coronavirus pandemic-findings from Israel. Isr J Health Policy Res. 2021 Mar 23;10(1):28. doi: 10.1186/s13584-021-00461-1.
PubMed 33757598
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ariel University Survey on Dietary Changes and Anxiety During the Coronavirus Pandemic: TARUS
- ClinicalTrials.gov ID
- NCT04353934
- Acronym / sponsor ID
- TARUS / AU-HEA-VKS-20200329
- Conditions
- Dietary Habits, Anxiety
- Keywords
- Coronavirus pandemic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,797 participants (actual)
- Lead sponsor
- Ariel UniversityUniversity, hospital or other
- Study start
- 31 Mar 2020 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 21 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Respondents | – | –All adults aged 18 or older who elect to respond to the online survey |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include all adult individuals who see and elect to complete the survey online and who provide informed consent by clicking on the appropriate button.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The association between Mediterranean Diet Score and Anxiety Score
Time frame: 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
Time frame: through study completion, average six months
Mediterranean Diet Score (MedDiet) will be calculated
1 secondary outcome
By-country comparisons of the association between Mediterranean Diet (MedDiet) score and Anxiety
Time frame: through study completion, average six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Background: PubMed 30642736Abu-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.
- Background: PubMed 29473255Esser P, Hartung TJ, Friedrich M, Johansen C, Wittchen HU, Faller H, Koch U, Harter 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.
- Derived from this study: PubMed 33757598Kaufman-Shriqui V, Navarro DA, Raz O, Boaz M. Multinational dietary changes and anxiety during the coronavirus pandemic-findings from Israel. Isr J Health Policy Res. 2021 Mar 23;10(1):28. doi: 10.1186/s13584-021-00461-1.
- Survey pageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Dietary Habits
Recruiting
Nutrition Outcomes Using a Randomized Intervention Via Smartphone on Dietary Habits
Healthy Adult Participants, Mindful Eating Intervention
Recruiting
Lifewise Preventive Video Education in Primary Care
Prevention Harmful Effects, Health Maintenance
Not yet recruiting
Project GAME ON! A Digital Comic Tool to Promote Healthy Behaviors
Obesity & Overweight, Childhood
Recruiting
SMART GOALS for Youth With Prediabetes
PreDiabetes, Adolescent Obesity
Recruiting
Can Food Timing Reduce Your Diabetes Risk?
Dietary Habits
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mona Boaz, RD, PhD principal investigator
Department of Nutrition Sciences, Ariel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dietary Habits and Anxiety, run by Ariel University at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The association between Mediterranean Diet Score and Anxiety Score (time frame: through study completion, average six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04353934, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.