Skip to main content
OpenTrials
Completed

NCT Number: NCT04357041

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

ALL, Adult Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • N/A

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Health-Related Quality of Life SF-12 Scale

    Time frame: 0-12 months

    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)

  2. State trait inventory for cognitive and somatic anxiety (STISA).

    Time frame: 0-12 months

    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)).

  3. Beck Depression inventory (BDI)

    Time frame: 0-12 months

    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

Sponsors and collaborators

Lead sponsor

Clinical Nutrition Research Center, Illinois Institute of Technology

Industry

Registry information

Official study title

Effects of Stay-at-home Guidance on Dietary Intake, Physical Activity and Overall Well-being During COVID-19 Public Health Crisis

Acronym: CoVS

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 22, 2020
Registry last updated
May 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.