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临床试验/NCT06637358
NCT06637358已完成不适用

A Text-based Reduction Intervention for Smokeless Tobacco Cessation- Pilot Study

Duke University2 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2024年11月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
69
试验地点
2
主要终点
Feasibility as measured by the number of recruited individuals who enrolled

研究概览

简要总结

All participants will receive the EnufSnuff.TXT scheduled gradual reduction (SGR) intervention for 6 weeks and, for those who do not reach the point of quit, includes getting randomized (like the flip of a coin) into either an additional 8-10 weeks of the EnufSnuff.TXT intervention or into receiving an additional 8-10 weeks of the EnufSnuff.TXT intervention along with a dedicated text quit coach to send and receive live support.

详细描述

All participants will receive the EnufSnuff.TXT intervention (a text-based personalized reduction plan and daily text-based cessation support messages) for 6 weeks and, for those who report that they have not achieved complete cessation, includes getting randomized into either an additional 8-10 weeks of the EnufSnuff.TXT intervention or into receiving an additional 8-10 weeks of the EnufSnuff.TXT intervention along with a dedicated quit coach to send and receive live text support. The investigators will conduct phone-based or smart phone-based assessments with participants at baseline, end of program, and 7-month follow-up after intervention completion. The investigators will also conduct a brief midpoint check (after the first 6 weeks of intervention) with participants to ask if they have quit using smokeless tobacco. Research staff will email participants redcap surveys at baseline, end of program, and 7-months. Participants will be able to opt for a recorded telephone interview at the 7-month check-in. Each opted-in participant will be interviewed only once.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age and older
  • Have used smokeless tobacco for the last year, currently dip 3 or more times a day
  • Have an address in a rural census tract defined by a RUCC code of 4-10 and/or an IMU of 62 or lower
  • Interested in participating in a cessation program; and
  • Have access to a cell phone with unlimited texting ability.

排除标准

  • Non-English speaking;
  • Have smoked cigarettes or used any other tobacco product in the past 30 days (i.e., dual user) and are not willing to abstain during the intervention period
  • Currently participating in a smokeless tobacco cessation study.

结局指标

主要结局

Feasibility as measured by the number of recruited individuals who enrolled

时间窗: Baseline

Feasibility as measured by the number of participants who left the study (attrition)

时间窗: Up to 6 months

Acceptability as measured by the number of participants who found the intervention useful

时间窗: Up to 6 months

As measured via telephone interview.

Acceptability as measured by the number of participants who reported that the intervention received changed their smokeless tobacco use

时间窗: Up to 6 months

As measured via telephone interview.

Acceptability as measured by the number of participants who reported that the intervention made them think about quitting

时间窗: Up to 6 months

As measured via telephone interview.

Acceptability as measured by the number of participants who reported that they would recommend the program to a friend

时间窗: Up to 6 months

As measured via telephone interview.

Preliminary efficacy as measured by the number of participants who quit smokeless tobacco by the end of treatment

时间窗: Up to approximately 16 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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