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

Primary Purpose

Tobacco Use Disorder

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Usual Care
Deposits
Small Individual Bonus
Large Individual Bonus
Teammate
Team Bonus
Sponsored by
University of California, Berkeley
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Use Disorder focused on measuring Smoking Cessation, Incentives, Health Behavior, Smoking, Work-site

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

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

Arm Description

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.

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.

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.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Program Acceptance
Proportion of eligible smokers who consent to participate in the main intervention
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

Full Information

First Posted
April 15, 2015
Last Updated
December 3, 2020
Sponsor
University of California, Berkeley
Collaborators
National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA), Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT02421224
Brief Title
Social and Monetary Incentives for Smoking Cessation at Large Employers
Acronym
SMILE
Official Title
Social and Monetary Incentives for Smoking Cessation at Large Employers
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Berkeley
Collaborators
National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA), Mahidol University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
Keywords
Smoking Cessation, Incentives, Health Behavior, Smoking, Work-site

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
4190 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Deposits
Arm Type
Experimental
Arm Description
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.
Arm Title
Small Individual Bonus
Arm Type
Experimental
Arm Description
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.
Arm Title
Large Individual Bonus
Arm Type
Experimental
Arm Description
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.
Arm Title
Team Bonus
Arm Type
Experimental
Arm Description
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.
Arm Title
Deposits plus Small Individual Bonus
Arm Type
Experimental
Arm Description
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.
Arm Title
Deposits plus Large Individual Bonus
Arm Type
Experimental
Arm Description
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.
Arm Title
Deposits plus Teammate
Arm Type
Experimental
Arm Description
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.
Arm Title
Deposits plus Team Bonus
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Deposits
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Small Individual Bonus
Intervention Description
Each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test.
Intervention Type
Behavioral
Intervention Name(s)
Large Individual Bonus
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Teammate
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Team Bonus
Intervention Description
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 Measure Information:
Title
Proportion of Participants With Smoking Abstinence at 12 Months
Description
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
Secondary Outcome Measure Information:
Title
Proportion of Participants With Smoking Abstinence at 3 Months
Description
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
Title
Program Acceptance
Description
Proportion of eligible smokers who consent to participate in the main intervention
Time Frame
At 0 months (at enrollment)
Title
Proportion of Participants With Smoking Abstinence at 6 Months
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William H. Dow, PhD
Organizational Affiliation
University of California, Berkeley
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mahidol University
City
Bangkok
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
33055176
Citation
White JS, Lowenstein C, Srivirojana N, Jampaklay A, Dow WH. Incentive programmes for smoking cessation: cluster randomized trial in workplaces in Thailand. BMJ. 2020 Oct 14;371:m3797. doi: 10.1136/bmj.m3797.
Results Reference
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Social and Monetary Incentives for Smoking Cessation at Large Employers

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