Smoking CessationNCT04489524
Smoking Cessation in NYC
A study testing individualized counselor-led MI sessions, general health education session and NRT in people with Smoking Cessation, run by Temple University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- individualized counselor-led MI sessions, general health education session and NRT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to 30 Apr 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- being currently pregnant and
- having had a recent diagnosis of cardiovascular disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Asian Health, Lewis Katz School of Medicine, Temple University
Philadelphia, Pennsylvania, 19140
About this study
Official title: 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.
- Conditions
- Smoking Cessation
- Being tested
- individualized counselor-led MI sessions, general health education session, NRT
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individualized counselor-led MI sessionsBehavioural
Intervention consisted of four 60-min in-person sessions of AMI counseling and a packet of self help smoking cessation materials.
general health education sessionBehavioural
four in-person 60-min health education sessions and packets of general health self-help information, nutrition, exercise, and the harmful effects of tobacco.
NRTBehavioural
nicotine replacement therapy
| Study group | Role | What they receive |
|---|---|---|
| individualized counselor-led MI sessions and NRT | Experimental | 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. Receives: Behavioral: individualized counselor-led MI sessions; Behavioral: NRT |
| general health education, self-help materials, and NRT | Active comparator | 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. Receives: Behavioral: general health education session; Behavioral: NRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in smoking behavior
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.
Measured: baseline, 1 week, 1, 3, and 6-month
change in Carbon monoxide (CO) concentration
CO, a biomarker of smoking status, was assessed at baseline and 6-m follow up
Measured: baseline, 6-month follow-up
change in the stages of smoking cessation
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
Measured: baseline, 1 week, 1, 3, and 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study startNov 2006
- Primary completion30 Apr 2008
- Study completion30 Apr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Grace X Ma, PhD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04489524
- Sponsor's protocol ID
- Quit Smoking
- Other IDs
- U01CA114582-02S2
- Status last verified
- Apr 2023
- First submitted
- 16 Jul 2020
- Last updated
- 13 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wu D, Ma GX, Zhou K, Zhou D, Liu A, Poon AN. The effect of a culturally tailored smoking cessation for Chinese American smokers. Nicotine Tob Res. 2009 Dec;11(12):1448-57. doi: 10.1093/ntr/ntp159. Epub 2009 Nov 13.
PubMed 19915080
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Culturally Tailored Smoking Cessation for Chinese Smokers in New York City
- ClinicalTrials.gov ID
- NCT04489524
- Acronym / sponsor ID
- Quit Smoking
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2006 (actual)
- Primary completion
- 30 Apr 2008 (actual)
- Study completion
- 30 Apr 2008 (actual)
- First posted
- 28 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| individualized counselor-led MI sessions and NRT | Experimental | Behavioral: individualized counselor-led MI sessions, Behavioral: NRTThe 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. |
| general health education, self-help materials, and NRT | Active comparator | Behavioral: general health education session, Behavioral: NRTParticipants 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. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Primary eligibility criterion for inclusion in the study cohort was current smoking status. Other inclusion criteria were:
Key exclusion criteria (2 listed)
- being currently pregnant and
- having had a recent diagnosis of cardiovascular disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| individualized counselor-led MI sessionsIntervention consisted of four 60-min in-person sessions of AMI counseling and a packet of self help smoking cessation materials. | Behavioural | individualized counselor-led MI sessions and NRT |
| general health education sessionfour in-person 60-min health education sessions and packets of general health self-help information, nutrition, exercise, and the harmful effects of tobacco. | Behavioural | general health education, self-help materials, and NRT |
| NRTnicotine replacement therapy | Behavioural | general health education, self-help materials, and NRT, individualized counselor-led MI sessions and NRT |
Primary outcome
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.
change in Carbon monoxide (CO) concentration
Time frame: baseline, 6-month follow-up
CO, a biomarker of smoking status, was assessed at baseline and 6-m follow up
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Background: PubMed 19915080Wu D, Ma GX, Zhou K, Zhou D, Liu A, Poon AN. The effect of a culturally tailored smoking cessation for Chinese American smokers. Nicotine Tob Res. 2009 Dec;11(12):1448-57. doi: 10.1093/ntr/ntp159. Epub 2009 Nov 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grace X Ma, PhD principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing individualized counselor-led MI sessions, general health education session and NRT in people with Smoking Cessation, run by Temple University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in smoking behavior (time frame: baseline, 1 week, 1, 3, and 6-month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04489524, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.