NCT04357041

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
440

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

April 17, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

May 17, 2023

Status Verified

May 1, 2023

Enrollment Period

1.1 years

First QC Date

April 17, 2020

Last Update Submit

May 16, 2023

Conditions

ALL, Adult

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Health-Related Quality of Life SF-12 Scale

    0-12 months

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

    0-12 months

  • Beck Depression inventory (BDI)

    0-12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Britt Burton-Freeman, Ph.D

    Illinois Insititute of Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2020

First Posted

April 22, 2020

Study Start

April 17, 2020

Primary Completion

June 1, 2021

Study Completion

July 31, 2021

Last Updated

May 17, 2023

Record last verified: 2023-05

Locations

US(1)