- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00714532
Smoking Reduction and Cessation Interventions for Chinese
A Stage-Based Scheduled Smoking Intervention for Chinese
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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.
- Participants receiving the experimental intervention will be more likely to report a 24- hour quit attempt at 3-, 6- and 12-month follow-up.
- 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.
- 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
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San Francisco, California, United States, 94143
- UCSF Langley Porter
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
Expert system which includes a stage-matched manual, and a series of 3 individualized tailored feedback reports at baseline, 1, and 3 months
|
Experimental: 2
The intervention consists of 3 components:
|
The intervention consists of 3 components:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
self-report 7-day smoking abstinence
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
self-report a 24-hour quit attempt
Time Frame: 12 months
|
12 months
|
50% or more reduction in smoking from baseline
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Janice Tsoh, PhD, University of California, San Francisco
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 14RT-0160H
- TRDRP grant: 14RT-0160H
- H10315-27252-03B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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