NCT04489524

Brief 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 program; and examined the effectiveness of this program on quit attempts, quit rates, and overall smoking reduction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2006

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2008

Completed
12.2 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 28, 2020

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

1.5 years

First QC Date

July 16, 2020

Last Update Submit

April 11, 2023

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (3)

  • 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.

    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

    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

    baseline, 1 week, 1, 3, and 6-month

Study Arms (2)

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.

Behavioral: individualized counselor-led MI sessionsBehavioral: 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.

Behavioral: general health education sessionBehavioral: NRT

Interventions

individualized counselor-led MI sessionsBEHAVIORAL

Intervention consisted of four 60-min in-person sessions of AMI counseling and a packet of self help smoking cessation materials.

individualized counselor-led MI sessions and NRT
general health education sessionBEHAVIORAL

four in-person 60-min health education sessions and packets of general health self-help information, nutrition, exercise, and the harmful effects of tobacco.

general health education, self-help materials, and NRT
NRTBEHAVIORAL

nicotine replacement therapy

general health education, self-help materials, and NRTindividualized counselor-led MI sessions and NRT

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • being currently pregnant and
  • having had a recent diagnosis of cardiovascular disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Asian Health, Lewis Katz School of Medicine, Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

Related Publications (1)

  • 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.

    PMID: 19915080BACKGROUND

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Grace X Ma, PhD

    Temple University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2020

First Posted

July 28, 2020

Study Start

November 1, 2006

Primary Completion

April 30, 2008

Study Completion

April 30, 2008

Last Updated

April 13, 2023

Record last verified: 2023-04

Locations

US(1)