Smoking Cessation
Conditions
Keywords
smoking cessation, nonsmokers, proxy, mail intervention, self-help, behavioral intervention
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.
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.
Interventions
BEHAVIORALMessages targeting nonsmokers
BEHAVIORALMessages targeting smokers
Sponsors
University of Oklahoma
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting 30-day Abstinence | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Support for Quitting | At intake | The number of participants who felt they had a lot of support for quitting or staying quit. |
| Number of Participants Reporting 30-day Abstinence | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Counseling | 7-months post enrollment | Did participants receive counseling |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Messages targeting nonsmokers | 1,044 |
| 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.
Messages targeting smokers | 1,038 |
| Usual Care one time mailing with a self-help quit kit | 1,043 |
| Total | 3,125 |
Baseline characteristics
| Characteristic | Messages Targeting Nonsmokers | Messages Targeting Smokers | Usual Care | Total |
|---|---|---|---|---|
| Age, Customized 18-24 | 116 Participants | 91 Participants | 109 Participants | 316 Participants |
| Age, Customized 25-44 | 487 Participants | 479 Participants | 496 Participants | 1462 Participants |
| Age, Customized 45-64 | 409 Participants | 420 Participants | 408 Participants | 1237 Participants |
| Age, Customized 65+ | 32 Participants | 48 Participants | 30 Participants | 110 Participants |
| Education 0 to 8 | 40 Participants | 45 Participants | 40 Participants | 125 Participants |
| Education 9 to 12 | 231 Participants | 202 Participants | 228 Participants | 661 Participants |
| Education BS+ | 58 Participants | 72 Participants | 49 Participants | 179 Participants |
| Education HSD/GED | 343 Participants | 338 Participants | 335 Participants | 1016 Participants |
| Education Some College | 372 Participants | 381 Participants | 391 Participants | 1144 Participants |
| Race/Ethnicity, Customized AIAN | 61 Participants | 46 Participants | 61 Participants | 168 Participants |
| Race/Ethnicity, Customized Asian | 9 Participants | 9 Participants | 11 Participants | 29 Participants |
| Race/Ethnicity, Customized Black | 289 Participants | 310 Participants | 275 Participants | 874 Participants |
| Race/Ethnicity, Customized Hispanic | 121 Participants | 107 Participants | 88 Participants | 316 Participants |
| Race/Ethnicity, Customized Multi | 73 Participants | 85 Participants | 65 Participants | 223 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 491 Participants | 481 Participants | 542 Participants | 1514 Participants |
| Sex: Female, Male Female | 566 Participants | 590 Participants | 566 Participants | 1722 Participants |
| Sex: Female, Male Male | 478 Participants | 448 Participants | 477 Participants | 1403 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 1,044 | 0 / 1,038 | 0 / 1,043 |
| serious Total, serious adverse events | 0 / 1,044 | 0 / 1,038 | 0 / 1,043 |
Outcome results
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).
Time frame: 7-months post enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Messages Targeting Nonsmokers | Number of Participants Reporting 30-day Abstinence | 203 Participants |
| Messages Targeting Smokers | Number of Participants Reporting 30-day Abstinence | 222 Participants |
| Usual Care | Number of Participants Reporting 30-day Abstinence | 135 Participants |
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).
Time frame: 3-months post enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Messages Targeting Nonsmokers | Number of Participants Reporting 30-day Abstinence | 120 Participants |
| Messages Targeting Smokers | Number of Participants Reporting 30-day Abstinence | 137 Participants |
| Usual Care | Number of Participants Reporting 30-day Abstinence | 56 Participants |
Secondary
Support for Quitting
The number of participants who felt they had a lot of support for quitting or staying quit.
Time frame: At intake
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Messages Targeting Nonsmokers | Support for Quitting | 690 Participants |
| Messages Targeting Smokers | Support for Quitting | 712 Participants |
| Usual Care | Support for Quitting | 704 Participants |
Other Pre-specified
Counseling
Did participants receive counseling
Time frame: 7-months post enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Messages Targeting Nonsmokers | Counseling | 20 Participants |
| Messages Targeting Smokers | Counseling | 58 Participants |
| Usual Care | Counseling | 0 Participants |