Viewing Study NCT00005720



Ignite Creation Date: 2024-05-05 @ 10:00 AM
Last Modification Date: 2024-10-26 @ 9:05 AM
Study NCT ID: NCT00005720
Status: COMPLETED
Last Update Posted: 2005-06-24
First Post: 2000-05-25

Brief Title: Lay-Led Smoking Cessation Approach for Southeast Asian Men
Sponsor: National Heart Lung and Blood Institute NHLBI
Organization: National Heart Lung and Blood Institute NHLBI

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 SE Asian counselors cadre were the primary agents for this studys 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 studys 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?: