Clinical trial NCT04357041: COVID-19 Survey Study on Dietary Intake, Physical Activity and Overall Well-being
Official title: Effects of Stay-at-home Guidance on Dietary Intake, Physical Activity and Overall Well-being During COVID-19 Public Health Crisis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ALL, Adult
Lead sponsor: Clinical Nutrition Research Center, Illinois Institute of Technology
Sponsor class: INDUSTRY
First posted: 2020-04-22
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Able to provide informed consent
* Able to comply and perform the procedures requested by the protocol

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Automated Self-Administered 24-Hour Dietary Recall (ASA24)
timeFrame: 0-12 months
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: 0-12 months
Secondary outcomes:
measure: Health-Related Quality of Life SF-12 Scale
timeFrame: 0-12 months
measure: State trait inventory for cognitive and somatic anxiety (STISA).
timeFrame: 0-12 months
measure: Beck Depression inventory (BDI)
timeFrame: 0-12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Clinical Nutrition Research Center
state: Illinois
Study officials:
affiliation: Illinois Insititute of Technology
name: Britt Burton-Freeman, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: