Effectiveness of the U-Niko intervention: Protocol for a cluster randomized controlled trial of a municipal-based tobacco and nicotine cessation intervention for adolescents and young adults

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Publicado en:PLoS One vol. 20, no. 10 (Oct 2025), p. e0323514
Autor principal: Sofie Bergman Rasmussen
Otros Autores: Christina Bjørk Petersen, Rasmussen, Mette, Kamstrup-Larsen, Nina, Pisinger, Charlotta
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Public Library of Science
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100 1 |a Sofie Bergman Rasmussen 
245 1 |a Effectiveness of the U-Niko intervention: Protocol for a cluster randomized controlled trial of a municipal-based tobacco and nicotine cessation intervention for adolescents and young adults 
260 |b Public Library of Science  |c Oct 2025 
513 |a Journal Article 
520 3 |a IntroductionThe use of nicotine products among youth is increasing, while existing cessation services remain underutilized. Thus, the U-Niko intervention has been developed to provide an evidence-based, youth-oriented approach for effective nicotine cessation.MethodsThis protocol describes a two-arm cluster randomized controlled trial of youth aged 16–25 in 55 municipalities in Denmark. Prior to the study a stratified randomization was carried out using the online randomization program Sealed Envelope, allocating 27 municipalities to the U-Niko intervention group and 28 municipalities to the control group (tobacco and nicotine cessation recruitment and counseling as usual). The primary outcomes will measure the effectiveness of all three focus areas in the intervention group compared to the control group: A) the municipal counselors’ self-efficacy in youth cessation counseling, B) the number of recruited youths for cessation counseling, and C) the self-reported 14-day point prevalence of abstinence of youth at six months follow-up. Secondary outcomes are the number of recruited youths in a municipality compared to the previous year, continuous abstinence, and validated 14-day point prevalence of abstinence at six-months follow-up.DiscussionBy evaluating all three focus areas of the U-Niko intervention, this study aims to provide robust evidence for improving youth cessation interventions at local and national levels.Trial registrationThe study was registered in ANZCTR (ACTRN12624001470583) on 18/12/2024. The Universal Trial Number is U1111-13-14-6117. 
651 4 |a Denmark 
653 |a Smoking cessation 
653 |a Adolescents 
653 |a Intervention 
653 |a Young adults 
653 |a Clusters 
653 |a Consultants 
653 |a Counseling 
653 |a Nicotine 
653 |a Abstinence 
653 |a Cooperation 
653 |a Municipalities 
653 |a Effectiveness 
653 |a Clinical trials 
653 |a Tobacco 
653 |a Randomization 
653 |a Feasibility studies 
653 |a Social 
700 1 |a Christina Bjørk Petersen 
700 1 |a Rasmussen, Mette 
700 1 |a Kamstrup-Larsen, Nina 
700 1 |a Pisinger, Charlotta 
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786 0 |d ProQuest  |t Health & Medical Collection 
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