Motivation, Tobacco Smoking Cessation
Conditions
Keywords
Tobacco smoking cessation, Motivation
Brief summary
The purpose of this study is to determine whether a behavioral economics solution impacts smoking cessation program engagement and quit rates.
Detailed description
The behavioral economics solution is a weekly regret contest in which participants can win or miss out on money based on their behavior.
Interventions
BEHAVIORALBehavioral economics incentives
Behavioral economics-informed incentives to promote engagement and outcomes in a smoking cessation intervention.
OTHERMinimal incentives
Minimal financial incentives to promote engagement and outcomes in a smoking cessation intervention.
Sponsors
National Institute on Aging (NIA)
Rhode Island Primary Care Physicians Corporation
Pro-Change Behavior Systems
VAL Health, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Be current tobacco users (specifically smokers) * Be 18 years old or over
Exclusion criteria
* Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Number of Completed Sessions Per Participant | Every 30 days for up to 6 months post-enrollment | Engagement rates for the intervention will be higher relative to the control arm. Engagement is measured by the number of complete tobacco cessation sessions per participant. |
| Outcome of Smoking Cessation Intervention | Every 30 days for up to 6 months post-enrollment | Quit levels for the intervention will be higher relative to the control arm. Quit level is defined as a participant who progresses to the stage in the tobacco cessation program where they quit smoking. The quit stages are levels 4 and 5 of the tobacco cessation program. |
Countries
United States
Participant flow
Recruitment details
Recruitment period: January to March, 2016. Recruitment methods: Physician and nurse referrals from Rhode Island Primary Care Physicians Corporation and Facebook advertisements. Intake method: Digital intake form hosted by Pro-Change.
Pre-assignment details
We identified and discontinued 34 participants whose accounts were were flagged as being suspicious. Duplicate accounts were erroneously created by a participant and thus were removed from the study. Suspicious accounts contained personal information identical to existing participants and after investigation, were concluded to be fraudulent.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care With Minimal Incentives Participants in this arm receive usual care from the Pro-Change smoking cessation program, and receive compensation for enrolling and completing a survey at the end of the study.
Minimal incentives: Minimal financial incentives to promote engagement, and outcomes in a smoking cessation intervention. | 210 |
| Usual Care With BE Incentives Participants in this arm receive usual care from the Pro-Change smoking cessation program, the chance to win money based on their behavior (Behavioral economics incentives), and receive compensation for enrolling and completing a survey at the end of the study.
Behavioral economics incentives: Behavioral economics-informed incentives to promote engagement and outcomes in a smoking cessation intervention. | 212 |
| Total | 422 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Fraudulent Entries | 20 | 14 |
Baseline characteristics
| Characteristic | Usual Care With Minimal Incentives | Usual Care With BE Incentives | Total |
|---|---|---|---|
| Age, Continuous | 44 years | 44 years | 44 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 18 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 196 Participants | 188 Participants | 384 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 6 Participants | 11 Participants |
| Region of Enrollment United States | 210 Participants | 212 Participants | 422 Participants |
| Sex: Female, Male Female | 138 Participants | 150 Participants | 288 Participants |
| Sex: Female, Male Male | 72 Participants | 62 Participants | 134 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 210 | 0 / 212 |
| other Total, other adverse events | 0 / 210 | 0 / 212 |
| serious Total, serious adverse events | 0 / 210 | 0 / 212 |
Outcome results
Primary
Average Number of Completed Sessions Per Participant
Engagement rates for the intervention will be higher relative to the control arm. Engagement is measured by the number of complete tobacco cessation sessions per participant.
Time frame: Every 30 days for up to 6 months post-enrollment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care With Minimal Incentives | Average Number of Completed Sessions Per Participant | 1.633 Average Number of Sessions |
| Usual Care With BE Incentives | Average Number of Completed Sessions Per Participant | 3.052 Average Number of Sessions |
p-value: <0.0001t-test, 2 sided
Primary
Outcome of Smoking Cessation Intervention
Quit levels for the intervention will be higher relative to the control arm. Quit level is defined as a participant who progresses to the stage in the tobacco cessation program where they quit smoking. The quit stages are levels 4 and 5 of the tobacco cessation program.
Time frame: Every 30 days for up to 6 months post-enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care With Minimal Incentives | Outcome of Smoking Cessation Intervention | 38 Participants |
| Usual Care With BE Incentives | Outcome of Smoking Cessation Intervention | 63 Participants |