Cardiovascular DiseasesNCT00005689
Trial of Smoking Cessation Programs in Black Churches
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Coronary Heart Disease Risk Reduction
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 1991to Jun 1995
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
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.
Read the 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.
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startJul 1991
- Study completionJun 1995
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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
- Time perspective
- Retrospective
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005689
- Sponsor's protocol ID
- 4185
- Status last verified
- Mar 2001
- First submitted
- 25 May 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Willems JP, Saunders JT, Hunt DE, Schorling JB. Prevalence of coronary heart disease risk factors among rural blacks: a community-based study. South Med J. 1997 Aug;90(8):814-20. doi: 10.1097/00007611-199708000-00008.
PubMed 9258308Schorling JB, Roach J, Siegel M, Baturka N, Hunt DE, Guterbock TM, Stewart HL. A trial of church-based smoking cessation interventions for rural African Americans. Prev Med. 1997 Jan-Feb;26(1):92-101. doi: 10.1006/pmed.1996.9988.
PubMed 9010903Willems JP, Hunt DE, Schorling JB. Coronary heart disease risk factors and cigarette smoking among rural African Americans. J Natl Med Assoc. 1997 Jan;89(1):37-47.
PubMed 9002415Schorling JB. The stages of change of rural African-American smokers. Am J Prev Med. 1995 May-Jun;11(3):170-7.
PubMed 7662396
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Smoking Cessation Programs in Black Churches
- ClinicalTrials.gov ID
- NCT00005689
- Acronym / sponsor ID
- 4185
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jul 1991
- Study completion
- Jun 1995
- First posted
- 26 May 2000 (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 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 design
- Time perspective
- Retrospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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
Not reported in the source record.
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 24 Jun 2005.
- Background: PubMed 9258308Willems JP, Saunders JT, Hunt DE, Schorling JB. Prevalence of coronary heart disease risk factors among rural blacks: a community-based study. South Med J. 1997 Aug;90(8):814-20. doi: 10.1097/00007611-199708000-00008.
- Background: PubMed 9010903Schorling JB, Roach J, Siegel M, Baturka N, Hunt DE, Guterbock TM, Stewart HL. A trial of church-based smoking cessation interventions for rural African Americans. Prev Med. 1997 Jan-Feb;26(1):92-101. doi: 10.1006/pmed.1996.9988.
- Background: PubMed 9002415Willems JP, Hunt DE, Schorling JB. Coronary heart disease risk factors and cigarette smoking among rural African Americans. J Natl Med Assoc. 1997 Jan;89(1):37-47.
- Background: PubMed 7662396Schorling JB. The stages of change of rural African-American smokers. Am J Prev Med. 1995 May-Jun;11(3):170-7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005689, which also lists 4 linked publications.
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 24 Jun 2005.