NCT00714532

Brief Summary

This study aims at developing and testing a stage-based scheduled smoking intervention that targets to encourage smokers to reduce smoking and to facilitate smoking abstinence. We hypothesize that smokers who receive the staged-based scheduled smoking intervention will be more likely to report smoking abstinence, quit attempts, and smoking reduction at 12 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
298

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 14, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

July 10, 2013

Status Verified

July 1, 2013

Enrollment Period

2.2 years

First QC Date

July 9, 2008

Last Update Submit

July 9, 2013

Conditions

Smoking Cessation

Keywords

smoking cessationAsian AmericanChinese Americansmoking reductionstage-based interventionexpert systemnicotine replacementcounseling

Outcome Measures

Primary Outcomes (1)

  • self-report 7-day smoking abstinence

    12 months

Secondary Outcomes (2)

  • self-report a 24-hour quit attempt

    12 months

  • 50% or more reduction in smoking from baseline

    12 months

Study Arms (2)

1

ACTIVE COMPARATOR

Expert system only, which includes a stage-matched manual, and a series of 3 individualized tailored feedback reports at baseline, 1, and 3 months.

Behavioral: Expert System Only

2

EXPERIMENTAL

The intervention consists of 3 components: * Expert system which includes a stage-matched manual, and a series of 3 individualized tailored feedback reports at baseline, 1, and 3 months * scheduled smoking intervention, which includes a tailored-made 3-week smoking reduction schedule and a stage-matched tip guide to explain why and how to use the smoking reduction intervention * telephone check-in calls to provide brief counseling and technical support to motivate participants to use the intervention materials * a 2-week supply of nicotine gum or lozenge per participants' choice to use during smoking reduction

Behavioral: Enhanced Expert System

Interventions

Expert System OnlyBEHAVIORAL

Expert system which includes a stage-matched manual, and a series of 3 individualized tailored feedback reports at baseline, 1, and 3 months

1
Enhanced Expert SystemBEHAVIORAL

The intervention consists of 3 components: * Expert system which includes a stage-matched manual, and a series of 3 individualized tailored feedback reports at baseline, 1, and 3 months * scheduled smoking intervention, which includes a tailored-made 3-week smoking reduction schedule and a stage-matched tip guide to explain why and how to use the smoking reduction intervention * telephone check-in calls to provide brief counseling and technical support to motivate participants to use the intervention materials * a 2-week supply of nicotine gum or lozenge per participants' choice to use during smoking reduction

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self-identified ethnic Chinese men and women
  • years or older
  • report smoking cigarettes daily with at least 5 cigarettes per day in the last 7 days
  • reside in California
  • be able to read written English or Chinese

You may not qualify if:

  • Currently engaging in assisted smoking cessation efforts
  • Have health conditions that have contraindications of using nicotine replacement treatment (NRT) such as pregnancy, within 6 months post MI, severe or unstable angina

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Langley Porter

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Smoking CessationSmoking Reduction

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSmoking

Study Officials

  • Janice Tsoh, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 9, 2008

First Posted

July 14, 2008

Study Start

April 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

July 10, 2013

Record last verified: 2013-07

Locations

US(1)