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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02010697
Other study ID # UO1 CA154280 IRB #130764
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2013
Est. completion date January 2016

Study information

Verified date February 2020
Source University of California, San Diego
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

This study examines the potential of enlisting nonsmokers to help smokers quit smoking. Nonsmokers are the majority of the society. If an intervention can be designed to mobilize nonsmokers to help smokers quit, then it has strong implications for increasing smoking cessation at the population level. The conventional approach in smoking cessation is to target smokers directly. This study aims to test whether targeting nonsmokers can be equally effective. The study employs a three arm randomized design, in which a smoker-nonsmoker pair in the same household will be randomized into one of the three groups. One group receives materials targeting the smoker in the household, one group receives materials targeting the nonsmoker, and the third group serve as a control group. The intervention consists of mailed materials which 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.The mail campaign is augmented with brief phone calls to ensure receipt of mailings and to reinforce targeted messages. At 3 and 7 months post randomization, project staff contact all participants to assess their smoking status.


Recruitment information / eligibility

Status Completed
Enrollment 3125
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 18 years or older

- A household with at least one smoker and one nonsmoker

- Valid contact information

- English proficiency, both speaking and reading

Exclusion Criteria:

- Insufficient contact information

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Messages targeting nonsmokers

Messages targeting smokers


Locations

Country Name City State
United States University of California San Diego San Diego California

Sponsors (2)

Lead Sponsor Collaborator
University of California, San Diego University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Counseling Did participants receive counseling 7-months post enrollment
Primary 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 Support for Quitting The number of participants who felt they had "a lot" of support for quitting or staying quit. At intake
Secondary Number of Participants Reporting 30-day Abstinence Assessment interview is conducted over the phone at 3-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). 3-months post enrollment
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