Smoking Reduction and Cessation Interventions for Chinese

NCT ID: NCT00714532

Last Updated: 2013-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 298 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2009-06-30

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.

Detailed Description

The objective of the study is to document and systematically investigate the use of smoking reduction and cessation strategies targeting Chinese American smokers at various level of readiness to quit smoking.

Using a randomized controlled study design, the experimental intervention will be compared to a control group that will receive the expert system intervention only at 3-, 6- and 12-month follow-up. The primary aim is to test the following hypotheses:

1. Participants receiving the experimental intervention will be more likely to achieve at least a 50% reduction from baseline at 3-month (end of treatment), 6- and 12-month follow-up than participants in the control condition.

2. Participants receiving the experimental intervention will be more likely to report a 24- hour quit attempt at 3-, 6- and 12-month follow-up.

3. Participants receiving the experimental intervention will be report a longer length of abstinence in their quit attempts at 3-, 6- and 12-month follow-up.

4. The experimental condition will yield a higher rate of smoking abstinence at 3-, 6- and 12-month follow-up.

The secondary aim is to examine the feasibility of the proposed intervention which will be assessed by recruitment efficiency, refusal rates, adherence, usage, safety data, and perceived helpfulness of the intervention components. In addition, analyses will be pursued to explore both short- and long-term maintenance of smoking reduction achieved, the association between smoking reduction and changes in self-efficacy of resisting from smoking, stage movements (changes in readiness for quitting), and the use of coping strategies for smoking at follow-ups. The study will provide important empirical data for developing effective smoking cessation strategies that are culturally and linguistically appropriate for the Chinese American population.

Conditions

Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: ACTIVE_COMPARATOR

Expert System Only

Intervention Type: BEHAVIORAL

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

2

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

Group Type: EXPERIMENTAL

Enhanced Expert System

Intervention Type: BEHAVIORAL

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

Interventions

Expert System Only

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

Intervention Type: BEHAVIORAL

Enhanced Expert System

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Self-identified ethnic Chinese men and women
• 18 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Janice Tsoh, Ph.D.

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Janice Tsoh, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

UCSF Langley Porter

San Francisco, California, United States

Countries

United States

Other Identifiers

TRDRP grant: 14RT-0160H

Identifier Type: -

Identifier Source: secondary_id

H10315-27252-03B

Identifier Type: -

Identifier Source: secondary_id

14RT-0160H

Identifier Type: -

Identifier Source: org_study_id