SmokingNCT00187603
Protecting the 'Hood Against Tobacco
A study testing tobacco cessation program in people with Smoking, run by University of California, San Francisco at 1 site in United States.
Trial summary
Among all racial/ethnic groups, African Americans have the greatest risk of becoming ill or dying from tobacco-related diseases. Because of this disproportionate disease burden, it is particularly urgent that researchers focusing on tobacco control partner with African American communities. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- tobacco cessation program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Jun 2007
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- African American adults who have used tobacco in the last month
Who cannot join
- Unable to read or speak English
- Dependence on other substances (except for marijuana)
- Disabling health conditions that would prevent participation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: Protecting the 'Hood Against Tobacco: Cessation Project
Among all racial/ethnic groups, African Americans have the greatest risk of becoming ill or dying from tobacco-related diseases. Because of this disproportionate disease burden, it is particularly urgent that researchers focusing on tobacco control partner with African American communities. Intervention strategies which hold the tobacco industry accountable for its behavior are effective in changing views of tobacco use. In earlier work, the investigators found that information from internal tobacco industry documents, when shown to African American smokers, stimulated reflection about quitting and interest in disseminating information about industry targeting behaviors to others. However, to date there have been no attempts to utilize the information in industry documents as part of a smoking cessation intervention. In this project, the investigators will test whether a community co-developed, tailored quit-smoking program featuring exposures to African American-specific tobacco industry documents and media exercises in addition to proven individual quitting strategies can increase the number of people who quit smoking at six months and one year, as compared with usual care.
The specific aims of the project are to:
- test, using statistics, how well an innovative community-based, culturally tailored quit-smoking program for African Americans works at 6 and 12 months;
- test selected variables for how well they predict who will return to smoking;
- use interviews to identify additional individual and/or community factors associated with successful quitting or relapse; and
- collect information to evaluate the overall effectiveness of the CARA project collaborative efforts in developing and sustaining the project over time, enhancing community awareness of tobacco issues, and creation or enhancement of community tobacco control resources.
Read the detailed description
Among all racial/ethnic groups, African Americans have the greatest risk of becoming ill or dying from tobacco-related diseases. Because of this disproportionate disease burden, it is particularly urgent that researchers focusing on tobacco control partner with African American communities. Intervention strategies which hold the tobacco industry accountable for its behavior are effective in changing views of tobacco use. In earlier work, we found that information from internal tobacco industry documents, when shown to African American smokers, stimulated reflection about quitting and interest in disseminating information about industry targeting behaviors to others. However, to date there have been no attempts to utilize the information in industry documents as part of a smoking cessation intervention. In this project, we will test whether a community co-developed, tailored quit-smoking program featuring exposures to African American-specific tobacco industry documents and media exercises in addition to proven individual quitting strategies can increase the number of people who quit smoking at six months and one year, as compared with usual care.
The specific aims of the project are to:
- test, using statistics, how well an innovative community-based, culturally tailored quit-smoking program for African Americans works at 6 and 12 months;
- test selected variables for how well they predict who will return to smoking;
- use interviews to identify additional individual and/or community factors associated with successful quitting or relapse; and
- collect information to evaluate the overall effectiveness of the CARA project collaborative efforts in developing and sustaining the project over time, enhancing community awareness of tobacco issues, and creation or enhancement of community tobacco control resources.
- Conditions
- Smoking
- Being tested
- tobacco cessation program
- Keywords
- tobacco, cessation, smoking, smoking cessation
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tobacco cessation programBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking cessation (cotinine validation)
Measured: at 6 and 12 months
Secondary outcomes (1)
Qualitative interviews
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJul 2003
- Primary completionFeb 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Tobacco Related Disease Research Program
- Investigators
- Ruth E Malone, RN, PhD, Principal investigator, Associate Professor UCSF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00187603
- Sponsor's protocol ID
- 12AT-1700
- Status last verified
- Aug 2005
- First submitted
- 13 Sep 2005
- Last updated
- 8 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protecting the 'Hood Against Tobacco: Cessation Project
- ClinicalTrials.gov ID
- NCT00187603
- Acronym / sponsor ID
- 12AT-1700
- Conditions
- Smoking
- Keywords
- tobacco, cessation, smoking, smoking cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Tobacco Related Disease Research Program
- Study start
- Jul 2003
- Primary completion
- Feb 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 16 Sep 2005 (estimated)
- 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.
Among all racial/ethnic groups, African Americans have the greatest risk of becoming ill or dying from tobacco-related diseases. Because of this disproportionate disease burden, it is particularly urgent that researchers focusing on tobacco control partner with African American communities. Intervention strategies which hold the tobacco industry accountable for its behavior are effective in changing views of tobacco use. In earlier work, the investigators found that information from internal tobacco industry documents, when shown to African American smokers, stimulated reflection about quitting and interest in disseminating information about industry targeting behaviors to others. However, to date there have been no attempts to utilize the information in industry documents as part of a smoking cessation intervention. In this project, the investigators will test whether a community co-developed, tailored quit-smoking program featuring exposures to African American-specific tobacco industry documents and media exercises in addition to proven individual quitting strategies can increase the number of people who quit smoking at six months and one year, as compared with usual care.
The specific aims of the project are to:
- test, using statistics, how well an innovative community-based, culturally tailored quit-smoking program for African Americans works at 6 and 12 months;
- test selected variables for how well they predict who will return to smoking;
- use interviews to identify additional individual and/or community factors associated with successful quitting or relapse; and
- collect information to evaluate the overall effectiveness of the CARA project collaborative efforts in developing and sustaining the project over time, enhancing community awareness of tobacco issues, and creation or enhancement of community tobacco control resources.
Detailed description
Among all racial/ethnic groups, African Americans have the greatest risk of becoming ill or dying from tobacco-related diseases. Because of this disproportionate disease burden, it is particularly urgent that researchers focusing on tobacco control partner with African American communities. Intervention strategies which hold the tobacco industry accountable for its behavior are effective in changing views of tobacco use. In earlier work, we found that information from internal tobacco industry documents, when shown to African American smokers, stimulated reflection about quitting and interest in disseminating information about industry targeting behaviors to others. However, to date there have been no attempts to utilize the information in industry documents as part of a smoking cessation intervention. In this project, we will test whether a community co-developed, tailored quit-smoking program featuring exposures to African American-specific tobacco industry documents and media exercises in addition to proven individual quitting strategies can increase the number of people who quit smoking at six months and one year, as compared with usual care.
The specific aims of the project are to:
- test, using statistics, how well an innovative community-based, culturally tailored quit-smoking program for African Americans works at 6 and 12 months;
- test selected variables for how well they predict who will return to smoking;
- use interviews to identify additional individual and/or community factors associated with successful quitting or relapse; and
- collect information to evaluate the overall effectiveness of the CARA project collaborative efforts in developing and sustaining the project over time, enhancing community awareness of tobacco issues, and creation or enhancement of community tobacco control resources.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- African American adults who have used tobacco in the last month
Key exclusion criteria (3 listed)
- Unable to read or speak English
- Dependence on other substances (except for marijuana)
- Disabling health conditions that would prevent participation
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 |
|---|---|---|
| tobacco cessation program | Behavioural | – |
Primary outcome
Smoking cessation (cotinine validation)
Time frame: at 6 and 12 months
1 secondary outcome
Qualitative interviews
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 8 May 2008.
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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.
Ruth E Malone, RN, PhD principal investigator
Associate Professor UCSF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tobacco cessation program in people with Smoking, run by University of California, San Francisco 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 1 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 8 May 2008. 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 cessation (cotinine validation) (time frame: at 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2008.