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Lung DiseasesNCT00076921

Epidemiology & Intervention Research for Tobacco Control

An observational study of Lung Diseases, run by Johns Hopkins Bloomberg School of Public Health.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

  1. 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)
  1. 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

  2. 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.

  1. First posted9 Feb 2004 (estimated)
  2. Study startSep 2002
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

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)
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

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.

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