Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT00005720
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-05-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lay-Led Smoking Cessation Approach for Southeast Asian Men
Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: