COVID-19 Survey Study on Dietary Intake, Physical Activity and Overall Well-being (CoVS)

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.

Study Overview

• Status: Completed
• Conditions: ALL, Adult

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 Type: Observational
• Enrollment (Actual): 440

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60616
      • Clinical Nutrition Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• N/A

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Clinical Nutrition Research Center, Illinois Institute of Technology
• Investigators: Principal Investigator: Britt Burton-Freeman, Ph.D, Illinois Insititute of Technology

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2020
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): July 31, 2021

Study Registration Dates

• First Submitted: April 17, 2020
• First Submitted That Met QC Criteria: April 21, 2020
• First Posted (Actual): April 22, 2020

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IRB-2020-91

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No