- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02010697
Nonsmokers Helping Smokers Quit (Project BEST)
February 11, 2020 updated by: Shu-Hong Zhu, University of California, San Diego
Mail Campaigns That Target Smokers or Nonsmokers Who Live With Smokers
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
3125
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Diego, California, United States, 92111
- University Of California San Diego
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Messages targeting nonsmokers
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.
|
|
|
Experimental: Messages targeting smokers
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.
|
|
|
No Intervention: Usual care
one time mailing with a self-help quit kit
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Reporting 30-day Abstinence
Time Frame: 7-months post enrollment
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Support for Quitting
Time Frame: At intake
|
The number of participants who felt they had "a lot" of support for quitting or staying quit.
|
At intake
|
|
Number of Participants Reporting 30-day Abstinence
Time Frame: 3-months post enrollment
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Counseling
Time Frame: 7-months post enrollment
|
Did participants receive counseling
|
7-months post enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2013
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
December 2, 2013
First Submitted That Met QC Criteria
December 9, 2013
First Posted (Estimate)
December 13, 2013
Study Record Updates
Last Update Posted (Actual)
February 13, 2020
Last Update Submitted That Met QC Criteria
February 11, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- UO1 CA154280 IRB #130764
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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