Lung DiseasesNCT00076921
Epidemiology & Intervention Research for Tobacco Control
An observational study of Lung Diseases, run by Johns Hopkins Bloomberg School of Public Health.
Trial summary
To characterize the development of tobacco control capacity with staff from the Chinese Center's for Disease control (CDCs) at the provincial level and to have them develop and implement population-level interventions to build awareness and knowledge concerning the harms of smoking that could help lead to policy… Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Lung Diseases
- How many people
- 15,705 participants
- Where
- No sites listed yet
- Study dates
- Sep 2002to Dec 2012
- Phase
- Observational
- 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 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Household representatives in 7 selected provinces will complete a survey.
No eligibility criteria
About this study
Official title: Research on China Tobacco Control Epidemiology and Intervention
To characterize the development of tobacco control capacity with staff from the Chinese Center's for Disease control (CDCs) at the provincial level and to have them develop and implement population-level interventions to build awareness and knowledge concerning the harms of smoking that could help lead to policy action being taken to protect the population from the harms caused by smoking. Compare capacity, policy and, second-hand smoke exposure and smoking rates in selected provinces to national levels.
Read the detailed description
China is a particularly critical country for global tobacco control. It has the world's largest number of smokers, approximately 350 million, and the immense market afforded by the 60 percent of men who smoke and the 95 percent of women who do not smoke represents a prize target for the multinational tobacco companies. China has ratified the Framework Convention for Tobacco Control (FCTC) and now needs to implement its provisions across a large and diverse population. In this application, we propose a program of evidence-based community interventions to be implemented at the province and local levels with the overall objective of developing an approach for implementation nationally.
This application builds on a long-standing partnership between the Chinese Center for Disease Control and Prevention (China CDC), the Peking Union Medical College (PUMC) and the Johns Hopkins Bloomberg School of Public Health. That partnership began in 1995 with an agreement to collaborate on the conduct of China's 1996 national smoking survey. Our principal collaborator over those years, Dr. Gong-Huan Yang, is now Deputy Director of the China CDC and responsible for tobacco control at the national level. In the four years of funding to date from the Fogarty International Center (FIC), we have carried out a project in selected communities in three provinces, including urban and rural areas that provide a foundation for the intervention approach in this proposal. Specifically, we have carried out quantitative and qualitative studies to assess barriers to tobacco control and readiness for interventions, measured levels of airborne nicotine in key public environments, and developed capacity-building approaches. Our original FIC supported study involved three countries, China, Mexico and Brazil. However, this application will focus solely on China, as the latter two countries developed the necessary infrastructure and capacity to conduct research, publish their research findings, and seek further grants and government funding to sustain progress.
This application proposes a tobacco control study that will involve 7 provinces in a CDC-led initiative to develop a systematic mix of approaches. The plan uses strategies based on experiences from our work in China and from the American Stop Smoking Intervention Study for Cancer Prevention (ASSIST) and anticipates barriers that have been identified in the data collected to date. In the intervention provinces, the China CDC will team with the provincial-level CDCs to assess capacity for tobacco control and the current status of tobacco control, using an adapted version of the Strength of Tobacco Control (SOTC) index developed for evaluating ASSIST. This systematic characterization will highlight capacity needs. An extensive capacity development program, based in distance-based methods, will be used. We have the overall objective of preparing the China CDC to implement a proven approach to tobacco control at the national level. A household survey will be conducted and compared to the national survey results. Second-hand smoking will be assessed in selected locations in the 7 provinces.
- Conditions
- Lung Diseases
- Medical subject headings
- Lung Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare smoking rates and second-hand smoke exposure in 7 provinces to national data.
A national household survey was conducted. Provincial household surveys that adapted questions from the national survey were administered to gain provincial estimates.
Measured: 3 years
Secondary outcomes (2)
Change or increase in number of tobacco control policies at the provincial level
Policies in hospital, schools, worksites, government buildings, transportation facilities will be assessed to determine if they have implemented a policy.
Measured: 3 years
Determine change in ability to conduct tobacco control strategies.
An assessment of the provinces ability or capacity to conduct tobacco control strategies were compared at baseline and at the end of the project.
Measured: 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2004 (estimated)
- Study startSep 2002
- Primary completionDec 2012
- Study completionDec 2012
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 Lung DiseasesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 15,705 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Frances Stillman, Johns Hopkins Bloomberg School of Public Health
- Investigators
- Frances Stillman, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00076921
- Sponsor's protocol ID
- 1209
- Other IDs
- 5R01HL073699
- Status last verified
- Apr 2013
- First submitted
- 6 Feb 2004
- Last updated
- 10 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Stillman FA, Wipfli HL, Lando HA, Leischow S, Samet JM. Building capacity for international tobacco control research: the global tobacco research network. Am J Public Health. 2005 Jun;95(6):965-8. doi: 10.2105/AJPH.2004.047183.
PubMed 15914817
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on China Tobacco Control Epidemiology and Intervention
- ClinicalTrials.gov ID
- NCT00076921
- Acronym / sponsor ID
- 1209
- Conditions
- Lung Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15,705 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2002
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 9 Feb 2004 (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.
To characterize the development of tobacco control capacity with staff from the Chinese Center's for Disease control (CDCs) at the provincial level and to have them develop and implement population-level interventions to build awareness and knowledge concerning the harms of smoking that could help lead to policy action being taken to protect the population from the harms caused by smoking. Compare capacity, policy and, second-hand smoke exposure and smoking rates in selected provinces to national levels.
Detailed description
China is a particularly critical country for global tobacco control. It has the world's largest number of smokers, approximately 350 million, and the immense market afforded by the 60 percent of men who smoke and the 95 percent of women who do not smoke represents a prize target for the multinational tobacco companies. China has ratified the Framework Convention for Tobacco Control (FCTC) and now needs to implement its provisions across a large and diverse population. In this application, we propose a program of evidence-based community interventions to be implemented at the province and local levels with the overall objective of developing an approach for implementation nationally.
This application builds on a long-standing partnership between the Chinese Center for Disease Control and Prevention (China CDC), the Peking Union Medical College (PUMC) and the Johns Hopkins Bloomberg School of Public Health. That partnership began in 1995 with an agreement to collaborate on the conduct of China's 1996 national smoking survey. Our principal collaborator over those years, Dr. Gong-Huan Yang, is now Deputy Director of the China CDC and responsible for tobacco control at the national level. In the four years of funding to date from the Fogarty International Center (FIC), we have carried out a project in selected communities in three provinces, including urban and rural areas that provide a foundation for the intervention approach in this proposal. Specifically, we have carried out quantitative and qualitative studies to assess barriers to tobacco control and readiness for interventions, measured levels of airborne nicotine in key public environments, and developed capacity-building approaches. Our original FIC supported study involved three countries, China, Mexico and Brazil. However, this application will focus solely on China, as the latter two countries developed the necessary infrastructure and capacity to conduct research, publish their research findings, and seek further grants and government funding to sustain progress.
This application proposes a tobacco control study that will involve 7 provinces in a CDC-led initiative to develop a systematic mix of approaches. The plan uses strategies based on experiences from our work in China and from the American Stop Smoking Intervention Study for Cancer Prevention (ASSIST) and anticipates barriers that have been identified in the data collected to date. In the intervention provinces, the China CDC will team with the provincial-level CDCs to assess capacity for tobacco control and the current status of tobacco control, using an adapted version of the Strength of Tobacco Control (SOTC) index developed for evaluating ASSIST. This systematic characterization will highlight capacity needs. An extensive capacity development program, based in distance-based methods, will be used. We have the overall objective of preparing the China CDC to implement a proven approach to tobacco control at the national level. A household survey will be conducted and compared to the national survey results. Second-hand smoking will be assessed in selected locations in the 7 provinces.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Household representatives in 7 selected provinces will complete a survey.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compare smoking rates and second-hand smoke exposure in 7 provinces to national data.
Time frame: 3 years
A national household survey was conducted. Provincial household surveys that adapted questions from the national survey were administered to gain provincial estimates.
2 secondary outcomes
Change or increase in number of tobacco control policies at the provincial level
Time frame: 3 years
Determine change in ability to conduct tobacco control strategies.
Time frame: 3 years.
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 10 Apr 2013.
- Background: PubMed 15914817Stillman FA, Wipfli HL, Lando HA, Leischow S, Samet JM. Building capacity for international tobacco control research: the global tobacco research network. Am J Public Health. 2005 Jun;95(6):965-8. doi: 10.2105/AJPH.2004.047183.
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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.
Frances Stillman principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases, run by Johns Hopkins Bloomberg School of Public Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 10 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Compare smoking rates and second-hand smoke exposure in 7 provinces to national data. (time frame: 3 years). 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 NCT00076921, 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 10 Apr 2013.