- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01311115
Using Group Commitment for Smoking Cessation
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:
- 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.
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nakhon Nayok
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Ongkharak, Nakhon Nayok, Thailand, 26120
- Srinakharinwirot University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Group commitment contracts
In addition to education and counseling, the intervention includes the following components:
|
Other Names:
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 Names:
|
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.
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months after enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months after enrollment
|
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.
|
3 months after enrollment
|
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.
|
3 months after enrollment
|
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.
|
14 months after enrollment
|
Collaborators and Investigators
Collaborators
Investigators
- 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
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2010-04-1269
- 2P30AG012839-16 (NIH)
- R21HD056581 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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