Cardiovascular DiseasesNCT00005720
Lay-Led Smoking Cessation Approach for Southeast Asian Men
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To develop a scientifically valid and ethnically approved, lay-led smoking cessation intervention for Southeast Asian men and women, i-e., those from Cambodia, Laos, and Vietnam. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Lung Diseases, Obstructive
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1990to Aug 1996
- 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 develop a scientifically valid and ethnically approved, lay-led smoking cessation intervention for Southeast Asian men and women, i-e., those from Cambodia, Laos, and Vietnam.
Read the detailed description
BACKGROUND:
Economically disadvantaged Southeast Asian men were targeted because of their higher than average smoking prevalence rate, their extraordinary increased numbers, and the relative paucity of strategies to reach this hard-to-reach group.
DESIGN NARRATIVE:
Trained, lay S.E. Asian counselors (cadre) were the primary agents for this study's assessment, intervention, and follow -up of smoking cessation behaviors. Seven reasons for using this approach were cited, including the potential generalization of this approach to other populations.
Over the six year demonstration and education research study period, the investigators: collected baseline data on smoking and smoking cessation behaviors; designed ethnically approved strategies for the cessation and maintenance of smoking cessation behaviors based upon findings from the baseline assessment; implemented ethnically approved strategies for smoking cessation; maintained smoking cessation after initial quitting; and evaluated the effectiveness of the intervention.
On the macro level, an equal number of randomly selected subjects (E1) allocated equally among the three ethnic groups in one county were compared to an equal number of control subjects in geographically separate counties. On the micro level, E1 subjects were also compared to control subjects (C1) in the intervention county. All subjects were longitudinally followed. The standard for successful cessation was biochemically verified through salivary cotinine tests at one year of self-reported abstinence.
Among the study's features were the community-based (versus academic or clinical) nature of lay change agents, the deliberate integration of baseline data and scientific principles with ethnic values in the intervention approach, and a research design that allowed for both macro and micro comparisons of the intervention with control conditions.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Lung Diseases, Obstructive, Chronic Obstructive Pulmonary Disease
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Lung Diseases, Obstructive, Pulmonary Disease, Chronic Obstructive
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 startSep 1990
- Study completionAug 1996
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
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005720
- Sponsor's protocol ID
- 4929
- Status last verified
- Apr 2001
- First submitted
- 25 May 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Anderson J, Moeschberger M, Chen MS Jr, Kunn P, Wewers ME, Guthrie R. An acculturation scale for Southeast Asians. Soc Psychiatry Psychiatr Epidemiol. 1993 Jul;28(3):134-41. doi: 10.1007/BF00801744.
PubMed 8378809Moeschberger ML, Anderson J, Kuo YF, Chen MS Jr, Wewers ME, Guthrie R. Multivariate profile of smoking in Southeast Asian men: a biochemically verified analysis. Prev Med. 1997 Jan-Feb;26(1):53-8. doi: 10.1006/pmed.1996.9993.
PubMed 9010898Wewers ME, Dhatt RK, Moeschberger ML, Guthrie RM, Kuun P, Chen MS. Misclassification of smoking status among Southeast Asian adult immigrants. Am J Respir Crit Care Med. 1995 Dec;152(6 Pt 1):1917-21. doi: 10.1164/ajrccm.152.6.8520755.
PubMed 8520755Lafferty CK, Heaney CA, Chen MS Jr. Assessing decisional balance for smoking cessation among Southeast Asian males in the US. Health Educ Res. 1999 Feb;14(1):139-46. doi: 10.1093/her/14.1.139.
PubMed 10537943
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
- Lay-Led Smoking Cessation Approach for Southeast Asian Men
- ClinicalTrials.gov ID
- NCT00005720
- Acronym / sponsor ID
- 4929
- Conditions
- Cardiovascular Diseases, Heart Diseases, Lung Diseases, Obstructive, Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1990
- Study completion
- Aug 1996
- 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 develop a scientifically valid and ethnically approved, lay-led smoking cessation intervention for Southeast Asian men and women, i-e., those from Cambodia, Laos, and Vietnam.
Detailed description
BACKGROUND:
Economically disadvantaged Southeast Asian men were targeted because of their higher than average smoking prevalence rate, their extraordinary increased numbers, and the relative paucity of strategies to reach this hard-to-reach group.
DESIGN NARRATIVE:
Trained, lay S.E. Asian counselors (cadre) were the primary agents for this study's assessment, intervention, and follow -up of smoking cessation behaviors. Seven reasons for using this approach were cited, including the potential generalization of this approach to other populations.
Over the six year demonstration and education research study period, the investigators: collected baseline data on smoking and smoking cessation behaviors; designed ethnically approved strategies for the cessation and maintenance of smoking cessation behaviors based upon findings from the baseline assessment; implemented ethnically approved strategies for smoking cessation; maintained smoking cessation after initial quitting; and evaluated the effectiveness of the intervention.
On the macro level, an equal number of randomly selected subjects (E1) allocated equally among the three ethnic groups in one county were compared to an equal number of control subjects in geographically separate counties. On the micro level, E1 subjects were also compared to control subjects (C1) in the intervention county. All subjects were longitudinally followed. The standard for successful cessation was biochemically verified through salivary cotinine tests at one year of self-reported abstinence.
Among the study's features were the community-based (versus academic or clinical) nature of lay change agents, the deliberate integration of baseline data and scientific principles with ethnic values in the intervention approach, and a research design that allowed for both macro and micro comparisons of the intervention with control conditions.
Study design
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 8378809Anderson J, Moeschberger M, Chen MS Jr, Kunn P, Wewers ME, Guthrie R. An acculturation scale for Southeast Asians. Soc Psychiatry Psychiatr Epidemiol. 1993 Jul;28(3):134-41. doi: 10.1007/BF00801744.
- Background: PubMed 9010898Moeschberger ML, Anderson J, Kuo YF, Chen MS Jr, Wewers ME, Guthrie R. Multivariate profile of smoking in Southeast Asian men: a biochemically verified analysis. Prev Med. 1997 Jan-Feb;26(1):53-8. doi: 10.1006/pmed.1996.9993.
- Background: PubMed 8520755Wewers ME, Dhatt RK, Moeschberger ML, Guthrie RM, Kuun P, Chen MS. Misclassification of smoking status among Southeast Asian adult immigrants. Am J Respir Crit Care Med. 1995 Dec;152(6 Pt 1):1917-21. doi: 10.1164/ajrccm.152.6.8520755.
- Background: PubMed 10537943Lafferty CK, Heaney CA, Chen MS Jr. Assessing decisional balance for smoking cessation among Southeast Asian males in the US. Health Educ Res. 1999 Feb;14(1):139-46. doi: 10.1093/her/14.1.139.
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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 NCT00005720, 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.