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临床试验/NCT05586308
NCT05586308已完成不适用

Pilot Study of Incentive-based and Media Literacy-informed Approaches to Improve Vaping Cessation Among Young Adults

University of Nebraska1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年12月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Engagement_remote checkin_3

研究概览

简要总结

This study aims to evaluate the feasibility and compare the preliminary effect of vaping cessation program consisting of media literacy education and real-time text messaging support and leverage insights from behavioral economics to enhance social and financial incentives to improve program engagement, and eventually abstinence. Our hypotheses are that 1) the Combined arm is associated with improved vaping abstinence to the Media literacy and Financial incentive arms; and 2) the financial incentive-related arms (either Combined or Financial incentive) enhance engagement compared to the non-incentive related arms.

详细描述

The objective of this pilot study is to evaluate the feasibility and compare the potential effect of different vaping cessation intervention components in addition to evidence-based text-messaging support, including 1) media literacy interactive e-learning lessons, 2) financial incentives, and 3) combined (media literacy + financial incentive) on vaping abstinence among current young adult vapers over a three-month timeframe with the following specific aims: Aim 1. To assess the feasibility of a multi-component vaping cessation program; and Aim 2 To evaluate the preliminary effect of a multicomponent vaping cessation program. Eligible participants are young adults aged 19-29 and are current vapers (i.e., has vaped in the previous 30 days).We will employ a 4-arm, feasibility randomized trial design to determine the preliminary effect of different vaping intervention components on vaping abstinence over a 3-month timeframe, consisting of a 1-month quitting preparation phase and 2-month abstinence phase. Eligible participants (n=80) will be randomized (in a 1:1:1:1 ratio), using a computer-generated algorithm, to to one of four vaping cessation interventions: 1) Active control: text-messaging support, 2) Media literacy: media literacy + text-messaging support, 3) Financial incentive: financial incentive + text-messaging support, and 4) Combined: media literacy e-learning lessons + financial incentive + text-messaging support, at the baseline visit. Regardless of intervention arms, all enrolled participants will receive receive an evidence-base text-messaging support program for quitting vaping (This is Quitting). Participants will be followed through a 3-month study period including a 1-month quitting preparation phase and a 2-month abstinence phase. All participants will be asked to provide the 5 saliva cotinine samples- at baseline and end-of-study visits and 3 at video calls (remote submissions). Participants who assigned to the financial incentive Combined groups will be provided monetary rewards for submitting saliva cotinine samples during the abstinence period. To examine the feasibility of biomarker testing for toxic exposures, for a subsample of 20 participants, a panel of biomarkers of toxic exposures will be measured at baseline and at the end of study.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
19 Years 至 29 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 19-29
  • Report vaping in the previous 30 days
  • Have access to internet/video chat/SMS text message
  • Are interested in quitting vaping in the next 30 days

排除标准

  • Must meet all the inclusion criteria
  • Self-report as currently pregnant or planning to become pregnant in the next 3 months
  • Already involved in vaping cession programs (either behavioral or medical intervention)

研究组 & 干预措施

Active control

Other

Participants in this arm will receive an evidence-based text-messaging support.

干预措施: Text-massaging suport (Behavioral)

Media literacy

Active Comparator

Participants will receive media literacy e-learning lessons and an evidence-based text-messaging support.

干预措施: Text-massaging suport (Behavioral)

Media literacy

Active Comparator

Participants will receive media literacy e-learning lessons and an evidence-based text-messaging support.

干预措施: Media literacy (Behavioral)

Financial incentive

Active Comparator

Participants will receive financial incentive intervention and an evidence-based text-messaging support.

干预措施: Financial incentive (Behavioral)

Financial incentive

Active Comparator

Participants will receive financial incentive intervention and an evidence-based text-messaging support.

干预措施: Text-massaging suport (Behavioral)

Combined

Experimental

Participants will receive media literacy e-learning lessons, financial incentive, and an evidence-based text-messaging support program.

干预措施: Text-massaging suport (Behavioral)

Combined

Experimental

Participants will receive media literacy e-learning lessons, financial incentive, and an evidence-based text-messaging support program.

干预措施: Financial incentive (Behavioral)

Combined

Experimental

Participants will receive media literacy e-learning lessons, financial incentive, and an evidence-based text-messaging support program.

干预措施: Media literacy (Behavioral)

结局指标

主要结局

Engagement_remote checkin_3

时间窗: 3 months

Engagement will be assessed by proportions of participants who submitted the remote saliva cotinine sample at remote checkin 3.

Retention

时间窗: 3 months

The number of participants who completed the end-of-study assessment (Week 12).

次要结局

  • Biochemically Verified Vaping Abstinence(3 months)
  • Self-reported Vaping Abstinence(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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