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Completed

NCT Number: NCT04460417

Chicago Community Health Study

The study examined smokers from the initial COMPASS survey who live in one of three local Census tracks with large concentrations of minority populations and smoking rates, including Washington Park (98.8% African American, 60.5% smoker), Gage Park (76.7% Hispanic, 26.7% smoker), and Bridgeport (34.5% Asian, 27.0% Hispanic, 29.3% smoker), randomizing them to receipt of treatment as usual care advice (via a pamphlet form the National Cancer Institute) versus theoretically-driven and empirically-supported smoking cessation advice session delivered in-person at the UCM.

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Key information

Conditions

Smoking Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Currently reside in either the Washington Park, Gage Park, or Bridgeport communities based on current physical address at the time of initial contact for study participation
  • Identify as a current smoker (verified by self-report and exhaled carbon monoxide)
  • Willing and able to sign an informed consent
  • Stable residence and contact information throughout the follow-up period

Exclusion criteria

  • Not a current smoker
  • Does not live within the pre-determined neighborhood locations
  • Unable to sign informed consent

Treatment and study plan

Enhanced Care

Behavioral

The session began with the therapist reviewing the participants' personal feedback sheet within the context of clear messaging that there is no safe level of smoking and of how smoking affects the participant individually and the Black community collectively. The participant was encouraged to quit smoking, else to reduce smoking if abstinence was not desired, and to use NRT within the next week to help foster behavior change and alleviate withdrawal symptoms. This portion of the counseling was presented within a culturally-targeted framework such that myths regarding NRT common among persons with low health literacy were discussed and debunked and historical mistrust of the medical community and concerns about exploitation were also addressed. Each participant in EC was offered a starter kit of NRT with a one week supply of patches or lozenges.

Other names: EC

TAU

Behavioral

Participants met with a research assistant for 3-5 minutes and received the National Cancer Institute (NCI) pamphlet "Clearing the Air" and access to related online resources, which includes brief advice to quit smoking and medication information. They did not receive counseling or specialized care and were advised to refer to the resources should they be interested in quitting smoking.

Primary outcomes

  1. Smoking reduction

    Time frame: Past-week CPD at 1- and 6-month follow-up

    Change in average cigarettes per day (CPD)

  2. Quit attempts

    Time frame: Any reported (and serious) quit attempts since last session at 1- and 6-month follow-up

    Change in number of any and serious (12+hr) quit attempts

  3. Motivation to change smoking

    Time frame: Increases in stage of change at 1- and 6-month follow-ups

    Increase in motivation to change smoking behavior via smoking contemplation ladder (Biener-Abrams Contemplation Ladder) scores. Scores are on a 10-point scale from 0-10, with higher scores indicating higher motivation to quit smoking.

  4. Nicotine Replacement Therapy (NRT) use

    Time frame: Any reported NRT use since last session at 1- and 6- month follow-up

    Change in frequency of NRT use

  5. Nicotine Replacement Therapy (NRT) knowledge

    Time frame: More accurate knowledge about NRT at 1- and 6-month follow-ups

    Increase in accurate knowledge about NRT assessed by two items rated from a 1 (strongly disagree) to 7 (strongly agree) scale measuring agreement to the NRT myths, "NRT causes cancer" and "NRT is only used by weak people".

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

Health Behavior and Feedback Among Chicago Area Communities

Acronym: CCHS

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 7, 2020
Registry last updated
Jul 7, 2020

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.

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