NCT02010697

Brief Summary

This study examines whether nonsmokers can be mobilized to help smokers quit. We will test, via mail campaign, whether targeting nonsmokers can be equally effective in increasing smokers' quit rate as targeting smokers directly. The hypothesis is that both targeted interventions will lead to a higher quit rate than a control group, which receives one set of self-help materials. Each of the targeted intervention groups receives 10 mailings. Smoking status of all three groups will be measured at 3 and 7 months post randomization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,125

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2013

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

December 1, 2013

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 2, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 13, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

October 25, 2019

Completed
Last Updated

February 13, 2020

Status Verified

February 1, 2020

Enrollment Period

2.1 years

First QC Date

December 2, 2013

Results QC Date

October 2, 2019

Last Update Submit

February 11, 2020

Conditions

Smoking Cessation

Keywords

smoking cessationnonsmokersproxymail interventionself-helpbehavioral intervention

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Reporting 30-day Abstinence

    Assessment interview is conducted over the phone at 7-months post enrollment to determine 30-day abstinence. The interview will cover, as appropriate, tobacco use, use of quitting aids, and pattern of quitting (including slips and relapse situations).

    7-months post enrollment

Secondary Outcomes (2)

  • Support for Quitting

    At intake

  • Number of Participants Reporting 30-day Abstinence

    3-months post enrollment

Other Outcomes (1)

  • Counseling

    7-months post enrollment

Study Arms (3)

Messages targeting nonsmokers

EXPERIMENTAL

Messages targeting nonsmokers include 10 mailings for nonsmokers sent over 10 weeks. The mailed materials include postcards, informational materials, CDs, DVDs, coupons for cessation-related incentives such as nicotine patches, and links to secured websites. The mail campaign is augmented with brief phone calls to ensure receipt of mailings and to reinforce targeted messages.

Behavioral: Messages targeting nonsmokers

Messages targeting smokers

EXPERIMENTAL

Messages targeting smokers include 10 mailings for smokers sent over 10 weeks. The mailed materials include postcards, informational materials, CDs, DVDs, coupons for cessation-related incentives such as nicotine patches, and links to secured websites. The mail campaign is augmented with brief phone calls to ensure receipt of mailings and to reinforce targeted messages.

Behavioral: Messages targeting smokers

Usual care

NO INTERVENTION

one time mailing with a self-help quit kit

Interventions

Messages targeting nonsmokersBEHAVIORAL
Messages targeting nonsmokers
Messages targeting smokersBEHAVIORAL
Messages targeting smokers

Eligibility Criteria

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

You may qualify if:

  • years or older
  • A household with at least one smoker and one nonsmoker
  • Valid contact information
  • English proficiency, both speaking and reading

You may not qualify if:

  • Insufficient contact information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Diego

San Diego, California, 92111, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Results Point of Contact

Title
Principal Investigator
Organization
UCSD
szhu@ucsd.edu
8583001056

Study Officials

  • Shu-Hong Zhu, Ph.D.

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 2, 2013

First Posted

December 13, 2013

Study Start

December 1, 2013

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

February 13, 2020

Results First Posted

October 25, 2019

Record last verified: 2020-02

Locations

US(1)