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| Tracking Information | |
|---|---|
| First Received Date ICMJE | May 25, 2000 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | July 1991 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00005689 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Trial of Smoking Cessation Programs in Black Churches |
| Official Title ICMJE | |
| Brief Summary | To provide a comprehensive description of smoking beliefs and behavior among rural Blacks, and to test the effectiveness of smoking cessation strategies delivered through Black churches. |
| Detailed Description | DESIGN NARRATIVE: Two demographically similar rural counties in central Virginia were compared, one intervention and one control site. In each country, two cohorts were assembled, a random sample of all Black smokers (the community cohort), and all members of randomly sampled Black churches (the church cohort). The descriptive component of the study elicited the knowledge, beliefs, attitudes, and behavior concerning smoking from these cohorts. Cardiovascular risk factors, including blood pressure and cholesterol levels, were also determined in the community cohort. For the experimental component, a variety of interventions which have proven to be efficacious in other settings were implemented through Black churches. These included fostering a supportive environment, distributing self-help materials, and providing individual support and counselling through the use of peer facilitators. The results of the baseline psychosocial survey were used to modify these methods for local use. They were then implemented in a culturally appropriate fashion at the intervention sites. Baseline smoking rates were determined using the initial surveys in both counties. Smokers were surveyed again at the end of the interventions and one year later to establish one-year abstinence rates. These were used as the primary outcome variables for the analysis of effect. The principal effect of the interventions were measured by comparing smoking abstinence rates between the church cohorts in the intervention and control counties. Due to the extended nature of the social networks associated with the churches, the interventions may also have had an effect on individuals not directly exposed, and this was determined by comparing the outcomes in the community cohorts. Finally, the associations between the baseline psychosocial and physiologic variables, exposure to the interventions, and smoking cessation behavior were also analyzed, to characterize on a population basis those who were and were not influenced by these church-based programs. |
| Study Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Retrospective Study |
| Condition ICMJE |
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| Intervention ICMJE | |
| Study Arms / Comparison Groups | |
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | |
| Completion Date | June 1995 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | No eligibility criteria |
| Gender | Male |
| Ages | |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | |
| Administrative Information | |
| NCT ID ICMJE | NCT00005689 |
| Responsible Party | |
| Study ID Numbers ICMJE | 4185 |
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) |
| Verification Date | March 2001 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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