Chicago Community Health Study

Smoking Clinical Trial

— CCHS  

Official title:

Health Behavior and Feedback Among Chicago Area Communities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04460417
• Other study ID #: IRB16-1573
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: October 31, 2018

Study information

• Verified date: July 2020
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking

Intervention

Behavioral:
• Enhanced Care
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.
• TAU
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.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking reduction	Change in average cigarettes per day (CPD)	Past-week CPD at 1- and 6-month follow-up
Primary	Quit attempts	Change in number of any and serious (12+hr) quit attempts	Any reported (and serious) quit attempts since last session at 1- and 6-month follow-up
Primary	Motivation to change smoking	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.	Increases in stage of change at 1- and 6-month follow-ups
Primary	Nicotine Replacement Therapy (NRT) use	Change in frequency of NRT use	Any reported NRT use since last session at 1- and 6- month follow-up
Primary	Nicotine Replacement Therapy (NRT) knowledge	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".	More accurate knowledge about NRT at 1- and 6-month follow-ups