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Social and Monetary Incentives for Smoking Cessation at Large Employers (SMILE)

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ClinicalTrials.gov Identifier: NCT02421224
Recruitment Status : Completed
First Posted : April 20, 2015
Last Update Posted : April 9, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Mahidol University
Information provided by (Responsible Party):
University of California, Berkeley

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.

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Behavioral: Usual Care Behavioral: Deposits Behavioral: Small Individual Bonus Behavioral: Large Individual Bonus Behavioral: Teammate Behavioral: Team Bonus Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4190 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Social and Monetary Incentives for Smoking Cessation at Large Employers
Study Start Date : April 2015
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Behavioral: 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.

Experimental: 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.
Behavioral: 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.

Behavioral: 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.

Experimental: 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.
Behavioral: 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.

Behavioral: 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.

Experimental: 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.
Behavioral: 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.

Behavioral: 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.

Experimental: 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.
Behavioral: 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.

Behavioral: 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.

Behavioral: 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.

Experimental: 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.
Behavioral: 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.

Behavioral: 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.

Behavioral: 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.

Experimental: 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.
Behavioral: 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.

Behavioral: 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.

Behavioral: 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.

Experimental: 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.
Behavioral: 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.

Behavioral: 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.

Behavioral: 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.

Experimental: 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.
Behavioral: 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.

Behavioral: 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.

Behavioral: 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.

Behavioral: 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.




Primary Outcome Measures :
  1. Urine test for cotinine (a metabolite of nicotine) [ Time Frame: 12 months after enrollment ]
    The primary measure of smoking cessation is the 7-day point prevalence of abstinence measured 12 months after enrollment using a urine cotinine test. The urine test results will also be used to determine prolonged abstinence for 12 months.


Secondary Outcome Measures :
  1. Urine test for cotinine (a metabolite of nicotine) [ Time Frame: 3 months and 6 months after enrollment ]
    The urine test results will be used to calculate the 7-day point prevalence of abstinence at 3, 6, and 12 months and prolonged abstinence for 3, 6, and 12 months. The urine test results will also be used to calculate the relapse rate.

  2. Proportion participating [ Time Frame: At 0 months (at enrollment) ]
    This measure captures the proportion of eligible smokers who consent to participate in the main intervention. This will be a primary outcome measure for the study of the correlates of participation and a secondary outcome measure for the study of the intervention's main effects.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02421224


Locations
Thailand
Mahidol University
Bangkok, Thailand
Sponsors and Collaborators
University of California, Berkeley
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Mahidol University
Investigators
Principal Investigator: William H. Dow, PhD University of California, Berkeley

Responsible Party: University of California, Berkeley
ClinicalTrials.gov Identifier: NCT02421224     History of Changes
Other Study ID Numbers: UCaliforniaBerkeley
5R01DA035384 ( U.S. NIH Grant/Contract )
First Posted: April 20, 2015    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018

Keywords provided by University of California, Berkeley:
Smoking Cessation
Incentives
Health Behavior
Smoking
Work-site

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders