- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04489524
Smoking Cessation in NYC
April 11, 2023 updated by: Temple University
A Feasibility Study of Culturally Tailored Smoking Cessation for Chinese Smokers in New York City
The investigators tested the feasibility of a culturally and linguistically sensitive smoking cessation program with combined counseling and pharmacological components for Chinese smokers in New York City; identified factors and techniques that enhance the administration and appropriateness of the intervention program; and examined the effectiveness of this program on quit attempts, quit rates, and overall smoking reduction.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
139
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19140
- Center for Asian Health, Lewis Katz School of Medicine, Temple University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Primary eligibility criterion for inclusion in the study cohort was current smoking status. Other inclusion criteria were:
- self-identification as ethnic Chinese,
- aged 18 years and older,
- having smoked or puffed on a cigarette during the previous week,
- willingness to participate in the smoking cessation study,
- access to a functional telephone,
- expected presence in the study geographic area for a year or more, and
- not having been enrolled in the past or at the current time in any smoking cessation treatment programs.
Exclusion Criteria:
- being currently pregnant and
- having had a recent diagnosis of cardiovascular disease.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: individualized counselor-led MI sessions and NRT
The intervention (4 individualized counselor-led MI sessions and nicotine replacement therapy [NRT]) consisted of four 60-min in-person sessions of AMI counseling and a packet of self-help smoking cessation materials.
Participants were provided NRT packs and counseled on their use.
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Intervention consisted of four 60-min in-person sessions of AMI counseling and a packet of self help smoking cessation materials.
nicotine replacement therapy
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Active Comparator: general health education, self-help materials, and NRT
Participants in this condition were provided with four in-person 60-min health education sessions and packets of general health self-help information, nutrition, exercise, and the harmful effects of tobacco.
Strategies for quitting smoking were also provided to participants in this group as well as a supply of NRT and counseling on its use.
|
nicotine replacement therapy
four in-person 60-min health education sessions and packets of general health self-help information, nutrition, exercise, and the harmful effects of tobacco.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in smoking behavior
Time Frame: baseline, 1 week, 1, 3, and 6-month
|
participants were asked whether they had smoked or had a puff on a cigarette and the number of cigarettes smoked in the past 7 days at multiple assessment points.
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baseline, 1 week, 1, 3, and 6-month
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change in Carbon monoxide (CO) concentration
Time Frame: baseline, 6-month follow-up
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CO, a biomarker of smoking status, was assessed at baseline and 6-m follow up
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baseline, 6-month follow-up
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change in the stages of smoking cessation
Time Frame: baseline, 1 week, 1, 3, and 6-month
|
According to Prochaska and DiClemente ' s Stages of Change model, the stages are: precontemplation, contemplation, preparation, action, and maintenance.
It's an ordinal variable that measured at multiple assessment points
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baseline, 1 week, 1, 3, and 6-month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2006
Primary Completion (Actual)
April 30, 2008
Study Completion (Actual)
April 30, 2008
Study Registration Dates
First Submitted
July 16, 2020
First Submitted That Met QC Criteria
July 23, 2020
First Posted (Actual)
July 28, 2020
Study Record Updates
Last Update Posted (Actual)
April 13, 2023
Last Update Submitted That Met QC Criteria
April 11, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- Quit Smoking
- U01CA114582-02S2 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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