Smoking
Conditions
Keywords
Cigarette Smoking, Health Behavior, Intervention Studies, Personal Communication
Brief summary
The current study tested the effectiveness of four potentially important tailoring factors (decisional framework, self-efficacy, navigation autonomy, and proactive outreach) in the context of an online motivational intervention for smoking cessation. A fifth factor was originally planned by dropped during intervention development due to confounds with the other planned factors. Information learned from this study will inform how to best design an online interventions for smoking cessation. Participants were recruited from a large, regional U.S. health plan. Using a full factorial design to screen for important main effects and 2-way interactions, participants were randomized to receive one of 16 different experimental factor combinations and followed for one year to assess program impact on smokers' use of empirically-validated cessation treatment and abstinence.
Detailed description
The current study is a factorial screening experiment, consistent with the Multiphase Optimization Strategy. Participants were randomly assigned to one of 16 different combinations of the 4 experimental factors. Each factor was explored on 2 contrasting levels. Each contrasting factor level was then compared to the other, resulting in 4 analytic arms. Within each arm, all participants (n = 1865) were analyzed to determine the relative effect of each contrasting factor level on the primary and secondary outcomes of interest.
Interventions
BEHAVIORALMessage Tone
All participants receive an tailored, online smoking cessation program. Participants in this intervention group either receive content written in a prescriptive tone or a motivational tone.
BEHAVIORALNavigation
Persons in this arm either have their ability to navigate the site dictated for them based on their readiness to quit smoking or they are able to freely navigate through the website.
BEHAVIORALProactive Outreach
Persons receive periodic, proactively delivered email reminders to visit the intervention website.
BEHAVIORALTestimonials
People receive a personally-tailored testimonial as part of their online smoking cessation program.
Sponsors
University of Michigan
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Member of Group Health Cooperative * Currently Smoking at Least 5 Cigarettes/Day * Access to Email and the Internet * Read and Write English * 18 years or older * Not currently receiving tobacco cessation treatment * Capable of participating in online and phone surveys
Exclusion criteria
* Persons will be excluded if they do not meet above criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smoking Abstinence | 12 months | 7 day point prevalent abstinence |
| Treatment Utilization for Smoking Cessation | 12 months | confirmed use of pharmacotherapy or enrollment in health plan-sponsored counseling program |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from Group Health, a large, non-profit health plan in the US Pacific Northwest. Data were collected between May 2010 and November 2012. All intervention and data collection occurred online.
Participants by arm
| Arm | Count |
|---|---|
| Randomization Arm: 1 Persons assigned to this arm received the following intervention combination: Tone \[prescriptive\], Navigation \[dictated\], proactive emails \[yes\], and testimonials \[yes\]. | 116 |
| Radndomization Arm: 2 Persons assigned to this arm received the following intervention combination: Tone \[prescriptive\], Navigation \[not dictated\], proactive emails \[yes\], and testimonials \[yes\]. | 116 |
| Randomization Arm: 3 Persons assigned to this arm received the following intervention combination: Tone \[prescriptive\], Navigation \[dictated\], proactive emails \[no\], and testimonials \[yes\]. | 117 |
| Randomization Arm: 4 Persons assigned to this arm received the following intervention combination: Tone \[prescriptive\], Navigation \[not dictated\], proactive emails \[no\], and testimonials \[yes\]. | 117 |
| Randomization Arm: 5 Persons assigned to this arm received the following intervention combination: Tone \[prescriptive\], Navigation \[dictated\], proactive emails \[yes\], and testimonials \[no\]. | 117 |
| Randomization Arm: 6 Persons assigned to this arm received the following intervention combination: Tone \[prescriptive\], Navigation \[not dictated\], proactive emails \[yes\], and testimonials \[no\]. | 117 |
| Randomization Arm: 7 Persons assigned to this arm received the following intervention combination: Tone \[prescriptive\], Navigation \[dictated\], proactive emails \[no\], and testimonials \[no\]. | 116 |
| Randomization Arm: 8 Persons assigned to this arm received the following intervention combination: Tone \[prescriptive\], Navigation \[not dictated\], proactive emails \[no\], and testimonials \[no\]. | 117 |
| Randomization Arm: 9 Persons assigned to this arm received the following intervention combination: Tone \[motivational\], Navigation \[dictated\], proactive emails \[yes\], and testimonials \[yes\]. | 116 |
| Randomization Arm: 10 Persons assigned to this arm received the following intervention combination: Tone \[motivational\], Navigation \[not dictated\], proactive emails \[yes\], and testimonials \[yes\]. | 116 |
| Randomization Arm: 11 Persons assigned to this arm received the following intervention combination: Tone \[motivational\], Navigation \[dictated\], proactive emails \[no\], and testimonials \[yes\]. | 117 |
| Randomization Arm: 12 Persons assigned to this arm received the following intervention combination: Tone \[motivational\], Navigation \[not dictated\], proactive emails \[no\], and testimonials \[yes\]. | 117 |
| Randomization Arm: 13 Persons assigned to this arm received the following intervention combination: Tone \[motivational\], Navigation \[dictated\], proactive emails \[yes\], and testimonials \[no\]. | 116 |
| Randomization Arm: 14 Persons assigned to this arm received the following intervention combination: Tone \[motivational\], Navigation \[not dictated\], proactive emails \[yes\], and testimonials \[no\]. | 117 |
| Randomization Arm: 15 Persons assigned to this arm received the following intervention combination: Tone \[motivational\], Navigation \[dictated\], proactive emails \[no\], and testimonials \[no\]. | 117 |
| Randomization Arm: 16 Persons assigned to this arm received the following intervention combination: Tone \[motivational\], Navigation \[not dictated\], proactive emails \[no\], and testimonials \[no\]. | 116 |
| Total | 1,865 |
Baseline characteristics
| Characteristic | Radndomization Arm: 2 | Randomization Arm: 3 | Randomization Arm: 4 | Randomization Arm: 5 | Randomization Arm: 6 | Randomization Arm: 7 | Randomization Arm: 8 | Randomization Arm: 9 | Randomization Arm: 1 | Randomization Arm: 10 | Randomization Arm: 11 | Randomization Arm: 12 | Randomization Arm: 13 | Randomization Arm: 14 | Randomization Arm: 15 | Randomization Arm: 16 | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 7 Participants | 6 Participants | 7 Participants | 6 Participants | 8 Participants | 9 Participants | 8 Participants | 5 Participants | 4 Participants | 8 Participants | 6 Participants | 2 Participants | 4 Participants | 7 Participants | 7 Participants | 102 Participants |
| Age, Categorical Between 18 and 65 years | 108 Participants | 110 Participants | 111 Participants | 110 Participants | 111 Participants | 108 Participants | 108 Participants | 108 Participants | 111 Participants | 112 Participants | 109 Participants | 111 Participants | 114 Participants | 113 Participants | 110 Participants | 109 Participants | 1763 Participants |
| Age, Continuous | 44.06 years STANDARD_DEVIATION 14.95 | 42.83 years STANDARD_DEVIATION 15.06 | 45.93 years STANDARD_DEVIATION 13.82 | 43.49 years STANDARD_DEVIATION 14.34 | 43.84 years STANDARD_DEVIATION 14.39 | 45.19 years STANDARD_DEVIATION 14.6 | 44.33 years STANDARD_DEVIATION 15.05 | 44.56 years STANDARD_DEVIATION 15.43 | 43.34 years STANDARD_DEVIATION 14.5 | 43.82 years STANDARD_DEVIATION 14.24 | 46.09 years STANDARD_DEVIATION 14.75 | 45.03 years STANDARD_DEVIATION 14.26 | 42.29 years STANDARD_DEVIATION 15.07 | 43.69 years STANDARD_DEVIATION 14.95 | 44.39 years STANDARD_DEVIATION 14.95 | 43.99 years STANDARD_DEVIATION 14.97 | 44.2 years STANDARD_DEVIATION 14.7 |
| Region of Enrollment United States | 116 participants | 117 participants | 117 participants | 117 participants | 117 participants | 116 participants | 117 participants | 116 participants | 116 participants | 116 participants | 117 participants | 117 participants | 116 participants | 117 participants | 117 participants | 116 participants | 1865 participants |
| Sex: Female, Male Female | 79 Participants | 76 Participants | 66 Participants | 39 Participants | 76 Participants | 73 Participants | 69 Participants | 74 Participants | 75 Participants | 77 Participants | 72 Participants | 76 Participants | 65 Participants | 69 Participants | 76 Participants | 77 Participants | 1139 Participants |
| Sex: Female, Male Male | 37 Participants | 41 Participants | 51 Participants | 78 Participants | 41 Participants | 43 Participants | 48 Participants | 42 Participants | 41 Participants | 39 Participants | 45 Participants | 41 Participants | 51 Participants | 48 Participants | 41 Participants | 39 Participants | 726 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 1,865 | 0 / 1,865 | 0 / 1,865 | 0 / 1,865 |
| serious Total, serious adverse events | 0 / 1,865 | 0 / 1,865 | 0 / 1,865 | 0 / 1,865 |
Outcome results
Primary
Smoking Abstinence
7 day point prevalent abstinence
Time frame: 12 months
Population: Missing data imputed, so all enrolled participants were included in the final intent to treat analytic sample.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Message Tone: Prescriptive | Smoking Abstinence | Smoking prevalence: 'active' intervention grp | 13.0 percentage of abstinent participants |
| Message Tone: Prescriptive | Smoking Abstinence | smoking prevalence: comparison group | 14.5 percentage of abstinent participants |
| Testimonials | Smoking Abstinence | smoking prevalence: comparison group | 13.6 percentage of abstinent participants |
| Testimonials | Smoking Abstinence | Smoking prevalence: 'active' intervention grp | 13.8 percentage of abstinent participants |
| Navigation: Dictated | Smoking Abstinence | Smoking prevalence: 'active' intervention grp | 14.5 percentage of abstinent participants |
| Navigation: Dictated | Smoking Abstinence | smoking prevalence: comparison group | 13.0 percentage of abstinent participants |
| Proactive Outreach | Smoking Abstinence | Smoking prevalence: 'active' intervention grp | 13.3 percentage of abstinent participants |
| Proactive Outreach | Smoking Abstinence | smoking prevalence: comparison group | 14.2 percentage of abstinent participants |
Comparison: Comparison of persons assigned to Prescriptive message tone (n = 932) against persons assigned to Motivational message tone (n = 933).95% CI: [0.51, 1.51]
Comparison: Comparison of persons assigned to Testimonials (n = 933) against persons assigned to receive no testimonials (n = 932).95% CI: [0.66, 1.91]
Comparison: Comparison of persons assigned to the Dictated Navigation arm (n = 934) against persons assigned to assigned free navigation of the website (n = 931).95% CI: [0.7, 2.02]
Comparison: Comparison of persons assigned to Proactive Email Outreach (n = 933) against persons assigned to receive No Proactive Email Outreach (n = 932).95% CI: [0.43, 1.3]
Primary
Treatment Utilization for Smoking Cessation
confirmed use of pharmacotherapy or enrollment in health plan-sponsored counseling program
Time frame: 12 months
Population: Twenty-seven participants were excluded for not being enrolled in the health plan during the study period and not having access to the provided adjunct treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Message Tone: Prescriptive | Treatment Utilization for Smoking Cessation | Treatment utilization: % in active intervention | 26.1 % of participants using adjunct treatmen |
| Message Tone: Prescriptive | Treatment Utilization for Smoking Cessation | treatment utilization: % in comparison group | 25.8 % of participants using adjunct treatmen |
| Testimonials | Treatment Utilization for Smoking Cessation | treatment utilization: % in comparison group | 26.6 % of participants using adjunct treatmen |
| Testimonials | Treatment Utilization for Smoking Cessation | Treatment utilization: % in active intervention | 25.3 % of participants using adjunct treatmen |
| Navigation: Dictated | Treatment Utilization for Smoking Cessation | Treatment utilization: % in active intervention | 26.0 % of participants using adjunct treatmen |
| Navigation: Dictated | Treatment Utilization for Smoking Cessation | treatment utilization: % in comparison group | 25.9 % of participants using adjunct treatmen |
| Proactive Outreach | Treatment Utilization for Smoking Cessation | Treatment utilization: % in active intervention | 23.7 % of participants using adjunct treatmen |
| Proactive Outreach | Treatment Utilization for Smoking Cessation | treatment utilization: % in comparison group | 28.2 % of participants using adjunct treatmen |
Comparison: Comparison of persons assigned to Prescriptive message tone (n = 932) against persons assigned to Motivational message tone (n = 933).95% CI: [0.62, 1.43]
Comparison: Comparison of persons assigned to Testimonials (n = 933) against persons assigned to receive no testimonials (n = 932).95% CI: [0.46, 1.07]
Comparison: Comparison of persons assigned to the Dictated Navigation arm (n = 934) against persons assigned to assigned free navigation of the website (n = 931).95% CI: [0.51, 1.18]
Comparison: Comparison of persons assigned to Proactive Email Outreach (n = 933) against persons assigned to receive No Proactive Email Outreach (n = 932).95% CI: [0.44, 1.03]