- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT06926608
Actívatexto : 라틴계의 금연 및 신체 활동 발전
The purpose of this randomized controlled trial is to assess the efficacy of Actívatexto (Aim 1) and the mediators of the presumed treatment effect (Aim 2) among Latino adults who smoke. Actívatexto is a mobile intervention that integrates four components: 1) a text messaging program that promotes both smoking cessation and physical activity, 2) wearable devices to monitor physical activity, 3) smoking cessation pharmacotherapy [i.e., nicotine replacement therapies (NRT)], and 4) an online dashboard where the research team manages participants' incoming and outgoing data from both the text messaging program and wearable devices.
연구 개요
상세 설명
We will conduct a two-arm randomized controlled trial among Latinos who smoke and do not meet the recommended levels of physical activity (N=408). Participants will be recruited via community-based efforts and randomly assigned in a 1:1 ratio to Actívatexto (a mobile intervention that promotes both smoking cessation and physical activity) or Decídetexto (a mobile intervention that solely promotes smoking cessation). All participants will be provided with nicotine replacement therapies and a Fitbit Versa 4 device. Participants in both groups will complete a baseline assessment at enrollment and follow-up assessments at Months 3 and 6.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Francisco Cartujano, MD
- 전화번호: (585) 273-1646
- 이메일: francisco_cartujano@urmc.rochester.edu
연구 장소
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New York
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Rochester, New York, 미국, 14642
- 모병
- University of Rochester Medical Center
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연락하다:
- Francisco Cartujano, MD
- 전화번호: 585-353-0035
- 이메일: francisco_cartujano@urmc.rochester.edu
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Self-identify as Hispanic and/or Latino
- Know how to read and speak English and/or Spanish
- Be ≥ 18 years of age
- Not meet the recommended levels of physical activity (150 minutes of moderate to vigorous physical activity)
- Smoke cigarettes at least 3 days per week
- Be interested in quitting smoking in the next 30 days
- Have a cellphone with text messaging capability
- Know how to utilize text messages
- Be willing to wear a wearable device daily to monitor physical activity
- Be willing to complete all study visits
Exclusion Criteria:
- Use of tobacco products other than cigarettes in the past 30 days (including e-cigarettes)
- Being pregnant or breastfeeding
- Plan to move from their current residence in the next six months
- Another household member enrolled in the study
- Unable to become more physically active or engage in a fitness appraisal
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Actívatexto
Actívatexto is a mobile intervention that promotes both smoking cessation and physical activity. Actívatexto integrates four components: 1) a text messaging program that promotes both smoking cessation and physical activity, 2) wearable devices to monitor physical activity, 3) smoking cessation pharmacotherapy (i.e., nicotine replacement therapies), and 4) an online dashboard where the research team manages participants' incoming and outgoing data from both the text messaging program and wearable devices. |
Actívatexto is a mobile intervention that promotes both smoking cessation and physical activity. Actívatexto integrates four components: 1) a text messaging program that promotes both smoking cessation and physical activity, 2) wearable devices to monitor physical activity, 3) smoking cessation pharmacotherapy (i.e., nicotine replacement therapies), and 4) an online dashboard where the research team manages participants' incoming and outgoing data from both the text messaging program and wearable devices. |
|
활성 비교기: Decídetexto
Decídetexto is a mobile intervention that solely promotes smoking cessation. Decídetexto integrates three components: 1) a text messaging program that solely promotes smoking cessation, 2) smoking cessation pharmacotherapy (i.e., nicotine replacement therapies), and 3) an online dashboard where the research team manages participants' incoming and outgoing data from the text messaging program. |
Decídetexto is a mobile intervention that solely promotes smoking cessation. Decídetexto integrates three components: 1) a text messaging program that solely promotes smoking cessation, 2) smoking cessation pharmacotherapy (i.e., nicotine replacement therapies), and 3) an online dashboard where the research team manages participants' incoming and outgoing data from the text messaging program. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percent of participants with cotinine verified 7-day point prevalence abstinence
기간: Month 6
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Cotinine levels ≤15 ng/mL in saliva |
Month 6
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percent of participants with self-reported 7-day point prevalence abstinence
기간: Month 6
|
No cigarettes, "not even a puff", in the past 7 days |
Month 6
|
공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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