Vickerman Katrina A, Carpenter Kelly M, Mullis Kristina, Shoben Abigail B, Nemeth Julianna, Mayers Elizabeth, Klein Elizabeth G
RVO Health, Center for Wellbeing Research, Fort Mill, South Carolina.
RVO Health, Center for Wellbeing Research, Fort Mill, South Carolina.
Am J Prev Med. 2025 Feb;68(2):366-376. doi: 10.1016/j.amepre.2024.10.019. Epub 2024 Dec 11.
Broad-reaching, effective e-cigarette cessation interventions are needed.
This remote, randomized clinical trial tested a mHealth program and nicotine replacement therapy (NRT) for young adult vaping cessation.
SETTING/PARTICIPANTS: Social media was used from 2021 to 2022 to recruit 508 young adults (aged 18-24 years) in the U.S. who exclusively and regularly (20+ days of last 30) used e-cigarettes and were interested in quitting.
All were offered 2 coaching calls and needed to complete the first call for full study enrollment. Participants were randomized to one of 4 groups in the 2×2 design: mailed NRT (8 weeks versus none) and/or mHealth (yes versus no; stand-alone text program including links to videos and online content).
Self-reported 7-day point prevalence vaping abstinence at 3 months.
A total of 981 participants were eligible and randomized; 508 (52%) fully enrolled by completing the first call. Enrolled participants were 71% female, 31% non-White, and 78% vaped daily. Overall, 74% completed the 3-month survey. Overall, 83% in the mailed NRT groups and 24% in the no-mailed NRT groups self-reported NRT use. Intent-to-treat 7-day point prevalence abstinence rates (missing assumed vaping) were 41% for calls only, 43% for Calls+mHealth, 48% for Calls+NRT, and 48% for Calls+NRT+mHealth. There were no statistically significant differences for mailed NRT (versus no-mailed NRT; OR=1.3; 95% CI=0.91, 1.84; p=0.14) or mHealth (versus no mHealth; OR=1.04; 95% CI=0.73, 1.47; p=0.84).
This quitline-delivered intervention was successful at helping young adults quit vaping, with almost half abstinent after 3 months. Higher than anticipated quit rates reduced power to identify significant group differences. Mailed NRT and mHealth did not significantly improve quit rates, in the context of an active control of a 2-call coaching program. Future research is needed to examine the independent effects of coaching calls, NRT, and mHealth in a fully-powered randomized control trial.
clinicaltrials.gov NCT04974580.
需要广泛有效的电子烟戒烟干预措施。
这项远程随机临床试验测试了一项移动健康计划和尼古丁替代疗法(NRT)对年轻成人电子烟戒烟的效果。
设置/参与者:2021年至2022年利用社交媒体招募了508名美国年轻成人(年龄在18 - 24岁之间),他们仅定期(过去30天内20天以上)使用电子烟且有戒烟意愿。
所有参与者都获得了2次辅导电话,且需要完成第一次电话以正式纳入研究。参与者按2×2设计随机分为4组:邮寄NRT(8周或无)和/或移动健康计划(有或无;独立的文本计划,包括视频和在线内容链接)。
3个月时自我报告的7天点患病率电子烟戒断情况。
共有981名参与者符合条件并被随机分组;508名(52%)通过完成第一次电话正式纳入研究。纳入的参与者71%为女性,31%为非白人,78%每天使用电子烟。总体而言,74%的参与者完成了3个月的调查。总体而言,邮寄NRT组中83%的人以及未邮寄NRT组中24%的人自我报告使用了NRT。意向性分析7天点患病率戒断率(缺失值假定为仍在使用电子烟)仅辅导电话组为41%,辅导电话 + 移动健康计划组为43%,辅导电话 + NRT组为48%,辅导电话 + NRT + 移动健康计划组为48%。邮寄NRT(与未邮寄NRT相比;OR = 1.3;95% CI = 0.91, 1.84;p = 0.14)或移动健康计划(与无移动健康计划相比;OR = 1.04;95% CI = 0.73, 1.47;p = 0.84)之间无统计学显著差异。
这项通过戒烟热线提供的干预措施成功帮助年轻成人戒掉电子烟,3个月后近一半人实现戒断。高于预期的戒烟率降低了识别显著组间差异的检验效能。在有2次辅导电话的积极对照背景下,邮寄NRT和移动健康计划并未显著提高戒烟率。未来需要进行充分样本量的随机对照试验来研究辅导电话、NRT和移动健康计划的独立效果。
clinicaltrials.gov NCT04974580