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

BackgroundThe use of nicotine products among youth is rising, while existing cessation services remain underutilized. Thus, the U-Niko intervention was developed to provide an evidence-based, youth-oriented approach to effective nicotine cessation. MethodsA two-arm cluster randomized controlled trial will be conducted among youth aged 16-25 in 55 municipalities in Denmark. Using the online randomization program Sealed Envelope, we conducted a blinded stratified randomization of 55 Danish municipalities resulting in 27 municipalities in the U-Niko intervention group and 28 municipalities in the control group (tobacco and nicotine cessation recruitment and counseling as usual). The primary outcomes 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 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 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 a local and national level. Trial registrationThe study was registered in ANZCTR (ACTRN12624001470583) on 18/12/2024. The Universal Trial Number is U1111-13-14-6117.