NCT01592682

Brief Summary

This is a trial of household pairs of a Chinese smoker and nonsmoker randomized either to a smoke-free educational intervention or self-help control group. The smokefree educational intervention includes group education about smokefree environments and smoking cessation, follow-up phone calls, and tobacco exposure lab reports. The control group is referred to usual care with local in-language smoking cessation classes or quitline, and is otherwise assessment only. The investigators hypothesize that pairs in the intervention group will have higher rates of tobacco cessation and elimination of smoke exposure, compared to the control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
410

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 7, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

June 3, 2015

Status Verified

June 1, 2015

Enrollment Period

3.1 years

First QC Date

April 26, 2012

Last Update Submit

June 1, 2015

Conditions

Keywords

tobaccosecondhand smokeChineseNNAL

Outcome Measures

Primary Outcomes (3)

  • Smoking cessation

    12 months

  • Elimination of secondhand smoke exposure

    Nonsmoker

    12 months

  • Urine NNAL (4-(Methylnitrosamine)-1-(3-pyridyl)-1-butanol)

    Smoker and nonsmoker; NNAL is a tobacco-specific carcinogen

    12 months

Secondary Outcomes (3)

  • Cigarette consumption

    12 months

  • Rule for no smoking in home

    12 months

  • Reduction in secondhand smoke exposure

    12 months

Study Arms (2)

Usual care

NO INTERVENTION

Household pairs that are assessment only and receive usual care of local in-language smoking cessation resource referral including quitline.

Smokefree counseling

EXPERIMENTAL

Household pairs assigned to smokefree counseling intervention, consisting of group education sessions, tobacco exposure lab report, individual follow-up phone calls.

Behavioral: Smokefree counseling

Interventions

Smokefree counseling intervention involves group education sessions, follow-up phone calls, tobacco exposure lab report. Comparison is usual care with referral to local in-language smoking cessation services including quitline.

Smokefree counseling

Eligibility Criteria

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

You may qualify if:

  • Self-identified Chinese Americans who primarily speak Chinese
  • Self-identified current smoker men and nonsmoker women
  • Pair lives in same household

You may not qualify if:

  • Current smoker women
  • Nonsmoker men

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinatown Public Health Center

San Francisco, California, 94133, United States

Location

Related Publications (1)

  • Chang E, Dove M, Saw A, Tsoh JY, Fung LC, Tong EK. Home Smoking Bans and Urinary NNAL Levels to Measure Tobacco Smoke Exposure in Chinese American Household Pairs. Int J Environ Res Public Health. 2021 Jul 20;18(14):7682. doi: 10.3390/ijerph18147682.

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Elisa K Tong, MD, MA

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 26, 2012

First Posted

May 7, 2012

Study Start

April 1, 2012

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

June 3, 2015

Record last verified: 2015-06

Locations