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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3125

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Messages targeting nonsmokers
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.
Behavioral: Messages targeting smokers
No Intervention: Usual care
one time mailing with a self-help quit kit

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Diego

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Oklahoma

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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