Tobacco Use Disorder
Conditions
Keywords
Smoking Cessation, Incentives, Health Behavior, Smoking, Work-site
Brief summary
The investigators will conduct a cluster randomized controlled trial of several behavioral interventions for smoking cessation among a sample of employees at large workplaces in the Bangkok metropolitan area. The study aims to test the impacts of different incentive structures for smoking cessation on take-up, effectiveness, and cost-effectiveness. The interventions are designed to elucidate certain principles from the field of behavioral economics.
Interventions
BEHAVIORALUsual Care
Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan.
BEHAVIORALDeposits
Participants will have to deposit a certain amount of their own money at enrollment. Participants will be able to make additional voluntary deposits above the minimum amount during the intervention period. The participant will be refunded all deposits if he quits smoking at 3 months, as verified by a urine cotinine test. The participant will forfeit all deposits if he continues to smoke at 3 months, as verified by a urine cotinine test.
BEHAVIORALSmall Individual Bonus
Each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test.
BEHAVIORALLarge Individual Bonus
Each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test. The bonus is twice the value of that in the Small Individual Bonus group.
BEHAVIORALTeammate
Each participant will be randomly assigned one teammate to provide social support during the quit attempt. Each participant will be assigned to a participating coworker who speaks the same primary language and works the same work shift as the participant.
BEHAVIORALTeam Bonus
If the participant and assigned teammate both quit smoking at 3 months, as verified by a urine cotinine test, then each will receive a monetary bonus. The team bonus is equal in value to that in the Large Individual Bonus group.
Sponsors
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Mahidol University
University of California, Berkeley
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Current full-time employee of a participating company * Smoker of 100+ cigarettes during lifetime * Smoker of 10+ cigarettes per week * Individual is aged 18+ years old * Smoker wants to quit within the next 6 months
Exclusion criteria
* Expects to leave company within the next 12 months * Is currently pregnant * Are unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With Smoking Abstinence at 12 Months | 12 months after enrollment | 7-day point prevalence of abstinence measured 12 months after enrollment using self-reported abstinence and urine cotinine test results |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Program Acceptance | At 0 months (at enrollment) | Proportion of eligible smokers who consent to participate in the main intervention |
| Proportion of Participants With Smoking Abstinence at 3 Months | 3 months after enrollment | 7-day point prevalence of abstinence measured 3 months after enrollment based on self-reported abstinence and urine cotinine test results |
| Proportion of Participants With Smoking Abstinence at 6 Months | 6 months after enrollment | 7-day point prevalence of abstinence measured 6 months after enrollment based on self-reported abstinence and urine cotinine test results |
Countries
Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan.
Usual Care: Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan. | 444 |
| Deposits Same as Usual Care, plus participants will have to deposit a certain amount of their own money as an incentive to quit smoking. Participants will be able to make additional voluntary deposits above the minimum amount. The participant will be refunded all deposits if he quits smoking at 3 months, as verified by a urine cotinine test. The participant will forfeit all deposits if he continues to smoke at 3 months, as verified by a urine cotinine test.
Usual Care: Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan.
Deposits: Participants will have to deposit a certain amount of their own money at enrollment. Participants will be able to make additional voluntary deposits above the minimum amount during the intervention period. The participant will be refunded all deposits if he quits smoking at 3 months, as verified by a urine cotinine test. The participant will forfeit all deposits if he continues to smoke at 3 months, as verified by a urine cotinine test. | 397 |
| Small Individual Bonus Same as Usual Care, plus each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test.
Usual Care: Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan.
Small Individual Bonus: Each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test. | 508 |
| Large Individual Bonus Same as Usual Care, plus each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test. The bonus is twice the value of that in the Small Individual Bonus group.
Usual Care: Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan.
Large Individual Bonus: Each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test. The bonus is twice the value of that in the Small Individual Bonus group. | 482 |
| Team Bonus Same as Usual Care, plus each participant will be randomly assigned one teammate to provide social support during the quit attempt. If the participant and assigned teammate both quit smoking at 3 months, as verified by a urine cotinine test, then each will receive a monetary bonus. The team bonus is equal in value to that in the Large Individual Bonus group.
Usual Care: Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan.
Teammate: Each participant will be randomly assigned one teammate to provide social support during the quit attempt. Each participant will be assigned to a participating coworker who speaks the same primary language and works the same work shift as the participant.
Team Bonus: If the participant and assigned teammate both quit smoking at 3 months, as verified by a urine cotinine test, then each will receive a monetary bonus. The team bonus is equal in value to that in the Large Individual Bonus group. | 495 |
| Deposits Plus Small Individual Bonus Same as Usual Care, plus the participant will follow the protocol for deposits as described for the Deposits group and will follow the protocol for the monetary bonus as described for the Small Individual Bonus group.
Usual Care: Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan.
Deposits: Participants will have to deposit a certain amount of their own money at enrollment. Participants will be able to make additional voluntary deposits above the minimum amount during the intervention period. The participant will be refunded all deposits if he quits smoking at 3 months, as verified by a urine cotinine test. The participant will forfeit all deposits if he continues to smoke at 3 months, as verified by a urine cotinine test.
Small Individual Bonus: Each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test. | 515 |
| Deposits Plus Large Individual Bonus Same as Usual Care, plus the participant will follow the protocol for deposits as described for the Deposits group and will follow the protocol for the monetary bonus as described for the Large Individual Bonus group.
Usual Care: Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan.
Deposits: Participants will have to deposit a certain amount of their own money at enrollment. Participants will be able to make additional voluntary deposits above the minimum amount during the intervention period. The participant will be refunded all deposits if he quits smoking at 3 months, as verified by a urine cotinine test. The participant will forfeit all deposits if he continues to smoke at 3 months, as verified by a urine cotinine test.
Large Individual Bonus: Each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test. The bonus is twice the value of that in the Small Individual Bonus group. | 489 |
| Deposits Plus Teammate Same as Usual Care, plus the participant will follow the protocol for deposits as described for the Deposits group and will be randomly assigned one other participant to serve as a teammate who provides social support during the quit attempt.
Usual Care: Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan.
Deposits: Participants will have to deposit a certain amount of their own money at enrollment. Participants will be able to make additional voluntary deposits above the minimum amount during the intervention period. The participant will be refunded all deposits if he quits smoking at 3 months, as verified by a urine cotinine test. The participant will forfeit all deposits if he continues to smoke at 3 months, as verified by a urine cotinine test.
Teammate: Each participant will be randomly assigned one teammate to provide social support during the quit attempt. Each participant will be assigned to a participating coworker who speaks the same primary language and works the same work shift as the participant. | 364 |
| Deposits Plus Team Bonus Same as Usual Care, plus the participant will follow the protocol for deposits as described for the Deposits group, will be randomly assigned a teammate, and will follow the protocol for the monetary bonus as described for the Team Bonus group.
Usual Care: Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan.
Deposits: Participants will have to deposit a certain amount of their own money at enrollment. Participants will be able to make additional voluntary deposits above the minimum amount during the intervention period. The participant will be refunded all deposits if he quits smoking at 3 months, as verified by a urine test. The participant will forfeit all deposits if he continues to smoke at 3 months, as verified by a urine test.
Teammate: Each participant will be randomly assigned one teammate to provide social support during the quit attempt. Each participant will be assigned to a participating coworker who speaks the same primary language and works the same work shift as the participant.
Team Bonus: If the participant and assigned teammate both quit smoking at 3 months, as verified by a urine test, then each will receive a monetary bonus. The team bonus is equal in value to that in the Large Individual Bonus group. | 496 |
| Total | 4,190 |
Baseline characteristics
| Characteristic | Usual Care | Deposits | Small Individual Bonus | Large Individual Bonus | Team Bonus | Deposits Plus Small Individual Bonus | Deposits Plus Large Individual Bonus | Deposits Plus Teammate | Deposits Plus Team Bonus | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 32 years | 32 years | 31 years | 33 years | 30 years | 34 years | 31 years | 35 years | 32 years | 32 years |
| Race and Ethnicity Not Collected | — | — | — | — | — | — | — | — | — | 0 Participants |
| Region of Enrollment Thailand | 444 participants | 397 participants | 508 participants | 482 participants | 495 participants | 515 participants | 489 participants | 364 participants | 496 participants | 4190 participants |
| Sex: Female, Male Female | 3 Participants | 18 Participants | 20 Participants | 4 Participants | 2 Participants | 10 Participants | 25 Participants | 15 Participants | 9 Participants | 106 Participants |
| Sex: Female, Male Male | 439 Participants | 376 Participants | 487 Participants | 475 Participants | 489 Participants | 503 Participants | 464 Participants | 347 Participants | 486 Participants | 4066 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 444 | 2 / 397 | 1 / 508 | 2 / 482 | 0 / 495 | 1 / 515 | 0 / 489 | 1 / 364 | 1 / 496 |
| other Total, other adverse events | 0 / 444 | 0 / 397 | 0 / 508 | 0 / 482 | 0 / 495 | 0 / 515 | 0 / 489 | 0 / 364 | 0 / 496 |
| serious Total, serious adverse events | 0 / 444 | 0 / 397 | 0 / 508 | 0 / 482 | 0 / 495 | 0 / 515 | 0 / 489 | 0 / 364 | 0 / 496 |
Outcome results
Primary
Proportion of Participants With Smoking Abstinence at 12 Months
7-day point prevalence of abstinence measured 12 months after enrollment using self-reported abstinence and urine cotinine test results
Time frame: 12 months after enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Proportion of Participants With Smoking Abstinence at 12 Months | 42 Participants |
| Deposits | Proportion of Participants With Smoking Abstinence at 12 Months | 57 Participants |
| Small Individual Bonus | Proportion of Participants With Smoking Abstinence at 12 Months | 74 Participants |
| Large Individual Bonus | Proportion of Participants With Smoking Abstinence at 12 Months | 104 Participants |
| Team Bonus | Proportion of Participants With Smoking Abstinence at 12 Months | 60 Participants |
| Deposits Plus Small Individual Bonus | Proportion of Participants With Smoking Abstinence at 12 Months | 72 Participants |
| Deposits Plus Large Individual Bonus | Proportion of Participants With Smoking Abstinence at 12 Months | 91 Participants |
| Deposits Plus Teammate | Proportion of Participants With Smoking Abstinence at 12 Months | 49 Participants |
| Deposits Plus Team Bonus | Proportion of Participants With Smoking Abstinence at 12 Months | 67 Participants |
Secondary
Program Acceptance
Proportion of eligible smokers who consent to participate in the main intervention
Time frame: At 0 months (at enrollment)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Program Acceptance | 271 Participants |
| Deposits | Program Acceptance | 202 Participants |
| Small Individual Bonus | Program Acceptance | 345 Participants |
| Large Individual Bonus | Program Acceptance | 290 Participants |
| Team Bonus | Program Acceptance | 293 Participants |
| Deposits Plus Small Individual Bonus | Program Acceptance | 270 Participants |
| Deposits Plus Large Individual Bonus | Program Acceptance | 279 Participants |
| Deposits Plus Teammate | Program Acceptance | 173 Participants |
| Deposits Plus Team Bonus | Program Acceptance | 328 Participants |
Secondary
Proportion of Participants With Smoking Abstinence at 3 Months
7-day point prevalence of abstinence measured 3 months after enrollment based on self-reported abstinence and urine cotinine test results
Time frame: 3 months after enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Proportion of Participants With Smoking Abstinence at 3 Months | 40 Participants |
| Deposits | Proportion of Participants With Smoking Abstinence at 3 Months | 61 Participants |
| Small Individual Bonus | Proportion of Participants With Smoking Abstinence at 3 Months | 64 Participants |
| Large Individual Bonus | Proportion of Participants With Smoking Abstinence at 3 Months | 88 Participants |
| Team Bonus | Proportion of Participants With Smoking Abstinence at 3 Months | 56 Participants |
| Deposits Plus Small Individual Bonus | Proportion of Participants With Smoking Abstinence at 3 Months | 66 Participants |
| Deposits Plus Large Individual Bonus | Proportion of Participants With Smoking Abstinence at 3 Months | 89 Participants |
| Deposits Plus Teammate | Proportion of Participants With Smoking Abstinence at 3 Months | 38 Participants |
| Deposits Plus Team Bonus | Proportion of Participants With Smoking Abstinence at 3 Months | 73 Participants |
Secondary
Proportion of Participants With Smoking Abstinence at 6 Months
7-day point prevalence of abstinence measured 6 months after enrollment based on self-reported abstinence and urine cotinine test results
Time frame: 6 months after enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Proportion of Participants With Smoking Abstinence at 6 Months | 48 Participants |
| Deposits | Proportion of Participants With Smoking Abstinence at 6 Months | 54 Participants |
| Small Individual Bonus | Proportion of Participants With Smoking Abstinence at 6 Months | 62 Participants |
| Large Individual Bonus | Proportion of Participants With Smoking Abstinence at 6 Months | 104 Participants |
| Team Bonus | Proportion of Participants With Smoking Abstinence at 6 Months | 52 Participants |
| Deposits Plus Small Individual Bonus | Proportion of Participants With Smoking Abstinence at 6 Months | 67 Participants |
| Deposits Plus Large Individual Bonus | Proportion of Participants With Smoking Abstinence at 6 Months | 106 Participants |
| Deposits Plus Teammate | Proportion of Participants With Smoking Abstinence at 6 Months | 48 Participants |
| Deposits Plus Team Bonus | Proportion of Participants With Smoking Abstinence at 6 Months | 72 Participants |