Lay-Led Smoking Cessation Approach for Southeast Asian Men

Status Completed

Clinical 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.

Clinical Trial 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

N/A

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00005720
Study type	Observational
Source	National Heart, Lung, and Blood Institute (NHLBI)
Contact
Status	Completed
Phase	N/A
Start date	September 1990
Completion date	August 1996

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.