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Using Group Commitment for Smoking Cessation

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ClinicalTrials.gov Identifier: NCT01311115
Recruitment Status : Completed
First Posted : March 9, 2011
Results First Posted : September 15, 2022
Last Update Posted : September 15, 2022
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Srinakharinwirot University
Information provided by (Responsible Party):
William Dow, University of California, Berkeley

Tracking Information
First Submitted Date  ICMJE March 8, 2011
First Posted Date  ICMJE March 9, 2011
Results First Submitted Date  ICMJE August 23, 2022
Results First Posted Date  ICMJE September 15, 2022
Last Update Posted Date September 15, 2022
Study Start Date  ICMJE November 2010
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 23, 2022)
Smoking Status at 6 Months [ Time Frame: 6 months after enrollment ]
7-day point prevalence of smoking abstinence measured 6 months after enrollment, using a NicCheck urine cotinine test. Participants who self-report having smoked in the last 7 days, as part of the follow-up survey, are considered to be continuing smokers.
Original Primary Outcome Measures  ICMJE
 (submitted: March 8, 2011)
Smoking status at 6 months [ Time Frame: 6 months after enrollment ]
Smoking status, measured 6 months after enrollment, is determined using a NicCheck (TM) urine cotinine test.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2022)
  • Concordance of Smoking Status Between Partners at 6 Months [ Time Frame: 6 months after enrollment ]
    The concordance of smoking status among randomly assigned pairs: both abstain, both smoke, or one abstains and one smokes, measured using 7-day point-prevalence abstinence at 6 months after enrollment, measured using self-reported abstinence and urine cotinine testing. Participants in the control condition are assigned to a pair, but their partner's identity is never revealed during the study.
  • Smoking Status at 3 Months [ Time Frame: 3 months after enrollment ]
    7-day point prevalence of smoking abstinence measured 3 months after enrollment, using a NicCheck urine cotinine test. Participants who self-report having smoked in the last 7 days, as part of the follow-up survey, are considered to be continuing smokers.
  • Concordance of Smoking Status Between Partners at 3 Months [ Time Frame: 3 months after enrollment ]
    The concordance of smoking status among randomly assigned pairs: both abstain, both smoke, or one abstains and one smokes, measured using 7-day point-prevalence abstinence at 3 months after enrollment, measured using self-reported abstinence and urine cotinine testing. Participants in the control condition are assigned to a pair, but their partner's identity is never revealed during the study.
  • Smoking Status at 14 Months [ Time Frame: 14 months after enrollment ]
    7-day point prevalence of smoking abstinence measured 6 months after enrollment, using a NicCheck urine cotinine test. Participants who self-report having smoked in the last 7 days, as part of the follow-up survey, are considered to be continuing smokers.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2011)
  • Concordance of smoking status between partners at 6 months [ Time Frame: 6 months after enrollment ]
    Participants in the treatment condition will be assigned a partner. The concordance of smoking status among pairs--both quit, both smoke, or one quits and one smokes--will be measured using the NicCheck (TM) urine cotinine test.
  • Smoking status at 3 months [ Time Frame: 3 months after enrollment ]
    Smoking status, measured 3 months after enrollment, is determined using a NicCheck (TM) urine cotinine test.
  • Concordance of smoking status between partners at 3 months [ Time Frame: 3 months after enrollment ]
    Participants in the treatment condition will be assigned a partner. The concordance of smoking status among pairs--both quit, both smoke, or one quits and one smokes--will be measured using the NicCheck (TM) urine cotinine test.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Using Group Commitment for Smoking Cessation
Official Title  ICMJE Using Group Commitment for Smoking Cessation
Brief Summary

This study proposes a novel behavioral intervention to help smokers in Thailand to achieve their goals of quitting. Smoking treatment programs are rare throughout most of Asia and unlikely to meet the impending demand for quitting that tobacco control regulations is stimulating. New approaches are needed.

The present study is a randomized controlled trial to test the effectiveness of a novel, scalable approach to smoking cessation that is targeted toward rural Southeast Asian communities. Thailand is used as a test case to explore if pairs of smokers quit successfully after making financially-backed commitments and receiving cash incentives to quit. The control group receives education and counseling about quitting. In addition to education and counseling about quitting, the intervention includes two key components:

  1. Each participant is encouraged to deposit his "cigarette money" on a weekly basis, to be returned only if the smoker quits successfully within three months. Such commitment contracts, based on theory from behavioral economics, are designed to help a person to maintain self-control and motivation in the face of temptation.
  2. Each participant is paired with another study participant. If both quit, each receives a cash bonus. The joint incentives are designed to lead partners to support each other throughout the quit attempt.

Thus, group commitment contracts marshal a robust blend of elements: financial commitment, social support, peer pressure, and monetary rewards. A larger, follow-up evaluation will clarify the relative importance of each of these elements.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Smoking
Intervention  ICMJE
  • Behavioral: Group commitment contract
    1. Each participant is required to deposit at least 50 baht at enrollment. A deposit collector visits each participant on a weekly basis and collects additional deposits on a voluntary basis. All deposits are returned only if the smoker quits successfully within three months.
    2. The project gives a matching contribution of 150 baht for the initial deposit of at least 50 baht. All participants in the treatment group are further randomized to a one-month group and a three-month group. The one-month group receives an additional 150 baht of project funds if they deposit 100 baht of their money within one month of enrollment. The three-month group receives 150 baht for depositing 100 baht within three months of enrollment.
    3. Each participant is paired with another study participant. If both quit, each receives a cash bonus of 1,200 baht. At enrollment, pairs receive brief counseling on ways to support each other during the quit attempt.
    Other Names:
    • Commitment contract
    • Deposit contract
    • Contingency contract
    • Buddy intervention
    • Partner intervention
  • Behavioral: Smoking cessation education and counseling
    Participants receive educational pamphlets on reasons to quit smoking and strategies for quitting smoking. They also receive one-time, group counseling on quitting smoking from a nurse trained in smoking cessation counseling.
    Other Name: Smoking cessation counseling
Study Arms  ICMJE
  • Experimental: Group commitment contracts

    In addition to education and counseling, the intervention includes the following components:

    1. Each participant is encouraged to deposit his "cigarette money" on a weekly basis, to be returned only if the smoker quits successfully within three months.
    2. The project gives a series of two matching contributions of 150 baht each to participants who meet certain deposit requirements.
    3. Each participant is paired with another study participant. If both quit, each receives a cash bonus of 1,200 baht. At enrollment, pairs receive brief counseling on ways to support each other during the quit attempt.
    Interventions:
    • Behavioral: Group commitment contract
    • Behavioral: Smoking cessation education and counseling
  • Active Comparator: Education and counseling
    Participants in this group receive educational pamphlets about quitting smoking and one-time, group counseling from a nurse trained in smoking cessation counseling.
    Intervention: Behavioral: Smoking cessation education and counseling
Publications * White JS, Dow WH, Rungruanghiranya S. Commitment contracts and team incentives: a randomized controlled trial for smoking cessation in Thailand. Am J Prev Med. 2013 Nov;45(5):533-42. doi: 10.1016/j.amepre.2013.06.020.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 23, 2022)
201
Original Estimated Enrollment  ICMJE
 (submitted: March 8, 2011)
200
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Current smoker of at least 10 cigarettes per week and at least 100 cigarettes over the course of a lifetime
  • Residents of the study area in Nakhon Nayok province, which includes the six subdistricts of Klong Yai, Chumpon, Bueng San, Pak Phli, Khao Phoem, or Ongkharak

Exclusion Criteria:

  • Pregnant
  • Plans to leave the study area within the next 12 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01311115
Other Study ID Numbers  ICMJE 2010-04-1269
2P30AG012839-16 ( U.S. NIH Grant/Contract )
R21HD056581 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party William Dow, University of California, Berkeley
Original Responsible Party Justin White, University of California at Berkeley
Current Study Sponsor  ICMJE University of California, Berkeley
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • National Institute on Aging (NIA)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Srinakharinwirot University
Investigators  ICMJE
Study Director: Justin S White, MA, MSPH University of California at Berkeley
Principal Investigator: William H Dow, PhD University of California at Berkeley
Study Director: Suthat Rungruanghiranya, MD Srinakharinwirot University
PRS Account University of California, Berkeley
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP