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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01311115
Other study ID # 2010-04-1269
Secondary ID 2P30AG012839-16R
Status Completed
Phase N/A
First received
Last updated
Start date November 2010
Est. completion date March 2012

Study information

Verified date August 2022
Source University of California, Berkeley
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 201
Est. completion date March 2012
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Group commitment contract
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. 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. 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.
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.

Locations

Country Name City State
Thailand Srinakharinwirot University Ongkharak Nakhon Nayok

Sponsors (4)

Lead Sponsor Collaborator
University of California, Berkeley Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Aging (NIA), Srinakharinwirot University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Smoking Status at 6 Months 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. 6 months after enrollment
Secondary Concordance of Smoking Status Between Partners at 6 Months 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. 6 months after enrollment
Secondary Smoking Status at 3 Months 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. 3 months after enrollment
Secondary Concordance of Smoking Status Between Partners at 3 Months 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. 3 months after enrollment
Secondary Smoking Status at 14 Months 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. 14 months after enrollment
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