- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02421224
Social and Monetary Incentives for Smoking Cessation at Large Employers (SMILE)
2020년 12월 3일 업데이트: University of California, Berkeley
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.
연구 개요
상태
완전한
정황
연구 유형
중재적
등록 (실제)
4190
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Bangkok, 태국
- Mahidol University
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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.
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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.
|
|
실험적: 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.
|
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.
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.
|
|
실험적: 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.
|
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.
Each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test.
|
|
실험적: 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.
|
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.
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.
|
|
실험적: 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.
|
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.
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.
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.
|
|
실험적: 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.
|
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.
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.
Each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test.
|
|
실험적: 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.
|
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.
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.
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.
|
|
실험적: 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.
|
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.
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.
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.
|
|
실험적: 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.
|
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.
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.
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.
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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of Participants With Smoking Abstinence at 12 Months
기간: 12 months after enrollment
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7-day point prevalence of abstinence measured 12 months after enrollment using self-reported abstinence and urine cotinine test results
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12 months after enrollment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Proportion of Participants With Smoking Abstinence at 3 Months
기간: 3 months after enrollment
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7-day point prevalence of abstinence measured 3 months after enrollment based on self-reported abstinence and urine cotinine test results
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3 months after enrollment
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Program Acceptance
기간: At 0 months (at enrollment)
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Proportion of eligible smokers who consent to participate in the main intervention
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At 0 months (at enrollment)
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Proportion of Participants With Smoking Abstinence at 6 Months
기간: 6 months after enrollment
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7-day point prevalence of abstinence measured 6 months after enrollment based on self-reported abstinence and urine cotinine test results
|
6 months after enrollment
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: William H. Dow, PhD, University of California, Berkeley
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2015년 4월 1일
기본 완료 (실제)
2017년 8월 1일
연구 완료 (실제)
2017년 8월 1일
연구 등록 날짜
최초 제출
2015년 4월 15일
QC 기준을 충족하는 최초 제출
2015년 4월 15일
처음 게시됨 (추정)
2015년 4월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 12월 30일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 12월 3일
마지막으로 확인됨
2020년 12월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Usual Care에 대한 임상 시험
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Hospital Universitari de BellvitgeInstitut d'Investigació Biomèdica de Bellvitge완전한
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KK Women's and Children's HospitalDuke University; Duke-NUS Graduate Medical School; Health Promotion Board, Singapore; Sport...완전한
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Queen's University, BelfastBelfast Health and Social Care Trust; Southern Health and Social Care Trust빼는백내장 | 연령 관련 백내장
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Fondazione Don Carlo Gnocchi OnlusIstituto Di Ricerche Farmacologiche Mario Negri완전한
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Massachusetts General HospitalNational Institutes of Health (NIH); Samaritans of Boston아직 모집하지 않음자살 생각 | 자살 시도 | 자살
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Massachusetts General HospitalVanderbilt University Medical Center; University of Kentucky; University of Texas at Austin완전한
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Fondazione I.R.C.C.S. Istituto Neurologico Carlo...모병
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UConn HealthFood and Drug Administration (FDA); University of Connecticut아직 모집하지 않음
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Hallym University Medical Center아직 모집하지 않음자살 생각 | 자해 행위 | 자살 위험 | 청소년 정신 건강