ALL, Adult Clinical Trial
— CoVSOfficial title:
Effects of Stay-at-home Guidance on Dietary Intake, Physical Activity and Overall Well-being During COVID-19 Public Health Crisis
NCT number | NCT04357041 |
Other study ID # | IRB-2020-91 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 17, 2020 |
Est. completion date | July 31, 2021 |
Verified date | May 2023 |
Source | Clinical Nutrition Research Center, Illinois Institute of Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 440 |
Est. completion date | July 31, 2021 |
Est. primary completion date | June 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Able to provide informed consent - Able to comply and perform the procedures requested by the protocol Exclusion Criteria: - N/A |
Country | Name | City | State |
---|---|---|---|
United States | Clinical Nutrition Research Center | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Clinical Nutrition Research Center, Illinois Institute of Technology |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Automated Self-Administered 24-Hour Dietary Recall (ASA24) | The ASA24 system will be used to document the study participant diet during the study period. | 0-12 months | |
Primary | 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. | 0-12 months | |
Secondary | 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) | 0-12 months | |
Secondary | 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)). | 0-12 months | |
Secondary | 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 |
0-12 months |
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