ALL, AdultCoVSNCT04357041
COVID-19 Survey Study on Dietary Intake, Physical Activity and Overall Well-being
An observational study of ALL, Adult, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
Trial summary
The aim of this research is to collect dietary intake, physical activity, mood and stress data during and after the Illinois shelter-in-place and social distancing orders for the COVID-19 pandemic. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- ALL, Adult
- How many people
- 440 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2020to 31 Jul 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: Subjects will be recruited through our CNRC databases of individuals who come to our clinic in the past years, online advertisement, and word of mouth.
Who may be able to join
- Able to provide informed consent
- Able to comply and perform the procedures requested by the protocol
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Nutrition Research Center
Chicago, Illinois, 60616
About this study
Official title: Effects of Stay-at-home Guidance on Dietary Intake, Physical Activity and Overall Well-being During COVID-19 Public Health Crisis
The aim of this research is to collect dietary intake, physical activity, mood and stress data during and after the Illinois shelter-in-place and social distancing orders for the COVID-19 pandemic. The study's intent is to capture data during this unprecedented time to understand the non-infection consequences of social distancing and shelter-in-place, including duration of affect after orders are lifted.
Read the detailed description
The proposed study is an observational study. The study will include our previous subjects, those who are following the shelter- in- place order due to the COVID-19 pandemic. Demographic data of individuals participating in the study will be recorded. During this 12-month protocol, participants will be contacted through email to complete online questionnaires on weekly basis for 8 weeks, and then once every 4 weeks until the end of the study. Subjects will record their one-day food intake, physical activity, sleep, and stress and anxiety level, which takes ~1 hour to complete.
Subjects will be recruited through our CNRC databases of individuals who come to our clinic in the past 1 year, online advertisement, and word of mouth. A phone and/or email will be administered to ensure their eligibility using our standard tools and protocols. People who are willing and able to participate and meet the basic screening eligibility will be contacted through email for informed consent and the continuing of the study.
- Conditions
- ALL, Adult
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Automated Self-Administered 24-Hour Dietary Recall (ASA24)
The ASA24 system will be used to document the study participant diet during the study period.
Measured: 0-12 months
International Physical Activity Questionnaire (IPAQ)
IPAQ will be used to evaluate the current physical activity level of the participants during the study period. All continuous scores are expressed in MET-minutes/week, Walking = 3.3 METs, Moderate PA = 4.0 METs and Vigorous PA = 8.0 METs.
Measured: 0-12 months
Secondary outcomes (3)
Health-Related Quality of Life SF-12 Scale
Short Form 12 (Short Form12- SF12) quality of life scale will be used to evaluate health-related quality of life during the study period.The SF-12v2 is a health-related quality-of-life question- naire consisting of twelve questions that measure eight health domains to assess physical and mental health. Physical health-related domains include General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP). Mental health-related scales include Vi- tality (VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH). the raw scores could be transformed to provide scores for eight scales, each ranging from 0 (the worst) to 100 (the best)
Measured: 0-12 months
State trait inventory for cognitive and somatic anxiety (STISA).
STISA will be used to measure state and trait anxiety as well as cognitive and somatic anxiety during the study period.scale consists of 21 items that are rated on a 4-point Likert scale. Both the STICSA State and Trait scales were designed to have two factors. One factor reflects the cognitive symptoms of anxiety (10 items, highest score: 40 (the worst), lowest score 10 (the best) ), and the second factor reflects the somatic symptoms of anxiety (11 items, highest score: 44 (the worst), lowest score 11(the best)).
Measured: 0-12 months
Beck Depression inventory (BDI)
BDI will be used to investigate the stress levels of the individuals participating in the study during the study period. The highest possible total for the whole test would be 36, the lowest would be 0. scoring category: 1-10: normal; 11-16 Mild mood disturbance; 17-20: Borderline clinical depression; 21-30
:Moderate depression; 31-40:Severe depression; over 40: Extreme depression
Measured: 0-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start17 Apr 2020
- Primary completion1 Jun 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALL, AdultStudies of the same condition, open and under way.
- More trials run by Clinical Nutrition Research Center, Illinois Institute of TechnologyThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Britt Burton-Freeman, Ph.D, Principal investigator, Illinois Insititute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357041
- Sponsor's protocol ID
- IRB-2020-91
- Acronym
- CoVS
- Status last verified
- May 2023
- First submitted
- 17 Apr 2020
- Last updated
- 17 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Stay-at-home Guidance on Dietary Intake, Physical Activity and Overall Well-being During COVID-19 Public Health Crisis
- ClinicalTrials.gov ID
- NCT04357041
- Acronym / sponsor ID
- CoVS / IRB-2020-91
- Conditions
- ALL, Adult
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of TechnologyIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 22 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.
The aim of this research is to collect dietary intake, physical activity, mood and stress data during and after the Illinois shelter-in-place and social distancing orders for the COVID-19 pandemic. The study's intent is to capture data during this unprecedented time to understand the non-infection consequences of social distancing and shelter-in-place, including duration of affect after orders are lifted.
Detailed description
The proposed study is an observational study. The study will include our previous subjects, those who are following the shelter- in- place order due to the COVID-19 pandemic. Demographic data of individuals participating in the study will be recorded. During this 12-month protocol, participants will be contacted through email to complete online questionnaires on weekly basis for 8 weeks, and then once every 4 weeks until the end of the study. Subjects will record their one-day food intake, physical activity, sleep, and stress and anxiety level, which takes ~1 hour to complete.
Subjects will be recruited through our CNRC databases of individuals who come to our clinic in the past 1 year, online advertisement, and word of mouth. A phone and/or email will be administered to ensure their eligibility using our standard tools and protocols. People who are willing and able to participate and meet the basic screening eligibility will be contacted through email for informed consent and the continuing of the study.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited through our CNRC databases of individuals who come to our clinic in the past years, online advertisement, and word of mouth.
Key inclusion criteria (2 listed)
- Able to provide informed consent
- Able to comply and perform the procedures requested by the protocol
Key exclusion criteria (1 listed)
- N/A
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
Automated Self-Administered 24-Hour Dietary Recall (ASA24)
Time frame: 0-12 months
The ASA24 system will be used to document the study participant diet during the study period.
International Physical Activity Questionnaire (IPAQ)
Time frame: 0-12 months
IPAQ will be used to evaluate the current physical activity level of the participants during the study period. All continuous scores are expressed in MET-minutes/week, Walking = 3.3 METs, Moderate PA = 4.0 METs and Vigorous PA = 8.0 METs.
3 secondary outcomes
Health-Related Quality of Life SF-12 Scale
Time frame: 0-12 months
State trait inventory for cognitive and somatic anxiety (STISA).
Time frame: 0-12 months
Beck Depression inventory (BDI)
Time frame: 0-12 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 17 May 2023.
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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.
Britt Burton-Freeman, Ph.D principal investigator
Illinois Insititute of Technology
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 ALL, Adult, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. 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 17 May 2023. 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 United States. 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?
Automated Self-Administered 24-Hour Dietary Recall (ASA24) (time frame: 0-12 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?
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 17 May 2023.