SmokingCCHSNCT04460417
Chicago Community Health Study
A study testing Enhanced Care and TAU in people with Smoking, run by University of Chicago at 1 site in United States.
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%… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Enhanced Care and TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 31 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not a current smoker
- Does not live within the pre-determined neighborhood locations
- Unable to sign informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Health Behavior and Feedback Among Chicago Area Communities
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.
- Conditions
- Smoking
- Being tested
- Enhanced Care, TAU
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced CareBehavioural
Also called EC
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.
TAUBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced care | Experimental | Participants will take part in an approximate one-hour health and smoking feedback session at the University of Chicago in Dr. King's Clinical Addictions Research Laboratory (CARL). The session will follow the Courage to Quit™ (CTQ) Roadmap program (developed by Dr. King with the Respiratory Health Association). This roadmap shorter version of the larger CTQ program has been specifically designed as an inpatient bedside or outpatient brief intervention guide to assess smoking cessation motivation, consequences of smoking, facts and myths about smoking, barriers to making a change, approved medications, de-bunking myths about medications or treatments without scientific evidence (e-cigarette, laser treatments, herbals, etc.), and gaining social support. Receives: Behavioral: Enhanced Care |
| Treatment as Usual | Active comparator | Participants will receive 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. Receives: Behavioral: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking reduction
Change in average cigarettes per day (CPD)
Measured: Past-week CPD at 1- and 6-month follow-up
Quit attempts
Change in number of any and serious (12+hr) quit attempts
Measured: Any reported (and serious) quit attempts since last session at 1- and 6-month follow-up
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.
Measured: Increases in stage of change at 1- and 6-month follow-ups
Nicotine Replacement Therapy (NRT) use
Change in frequency of NRT use
Measured: Any reported NRT use since last session at 1- and 6- month follow-up
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".
Measured: More accurate knowledge about NRT at 1- and 6-month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start1 Oct 2017
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea King, PhD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460417
- Sponsor's protocol ID
- IRB16-1573
- Acronym
- CCHS
- Status last verified
- Jul 2020
- First submitted
- 23 Jun 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brett EI, Chavarria J, Liu M, Hedeker D, King AC. Effects of a brief motivational smoking intervention in non-treatment seeking disadvantaged Black smokers. J Consult Clin Psychol. 2021 Apr;89(4):241-250. doi: 10.1037/ccp0000629. Epub 2021 Mar 11.
PubMed 33705158
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Behavior and Feedback Among Chicago Area Communities
- ClinicalTrials.gov ID
- NCT04460417
- Acronym / sponsor ID
- CCHS / IRB16-1573
- Conditions
- Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced care | Experimental | Behavioral: Enhanced CareParticipants will take part in an approximate one-hour health and smoking feedback session at the University of Chicago in Dr. King's Clinical Addictions Research Laboratory (CARL). The session will follow the Courage to Quit™ (CTQ) Roadmap program (developed by Dr. King with the Respiratory Health Association). This roadmap shorter version of the larger CTQ program has been specifically designed as an inpatient bedside or outpatient brief intervention guide to assess smoking cessation motivation, consequences of smoking, facts and myths about smoking, barriers to making a change, approved medications, de-bunking myths about medications or treatments without scientific evidence (e-cigarette, laser treatments, herbals, etc.), and gaining social support. |
| Treatment as Usual | Active comparator | Behavioral: TAUParticipants will receive 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Not a current smoker
- Does not live within the pre-determined neighborhood locations
- Unable to sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced CareAlso: ECThe 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. | Behavioural | Enhanced care |
| TAUParticipants 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. | Behavioural | Treatment as Usual |
Primary outcome
Smoking reduction
Time frame: Past-week CPD at 1- and 6-month follow-up
Change in average cigarettes per day (CPD)
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
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.
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
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".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Derived from this study: PubMed 33705158Brett EI, Chavarria J, Liu M, Hedeker D, King AC. Effects of a brief motivational smoking intervention in non-treatment seeking disadvantaged Black smokers. J Consult Clin Psychol. 2021 Apr;89(4):241-250. doi: 10.1037/ccp0000629. Epub 2021 Mar 11.
- Individual participant dataSharing planned: No
Related trials for Smoking
Active, not recruiting
An Interactive Smartphone Application to Motivate Smokers to Quit
Smoking Cessation, Smoking Behaviors
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruiting
Comparing the Efficacy of a Conversational Agent (QuitBot) Versus Standard Health Education on Smoking Cessation Among Medical Students; A Randomized Controlled Trial.
Conversational Agent, Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Active, not recruitingPhase 3
Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
Tobacco Dependence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea King, PhD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Care and TAU in people with Smoking, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking reduction (time frame: Past-week CPD at 1- and 6-month follow-up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04460417, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.