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Study protocol of the U-Niko trial: a cluster randomized controlled trial of a municipal-based tobacco and nicotine cessation intervention among adolescents and young adults

Study protocol of the U-Niko trial: Evaluating the feasibility and efficacy of a cluster randomized controlled trial of a municipal-based tobacco and nicotine cessation intervention among adolescents and young adults

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624001470583
Enrollment
605
Registered
2024-12-18
Start date
2025-01-01
Completion date
2025-12-31
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Efficacy evaluation of the U-Niko trial, a three-legged municipal-based tobacco- and nicotine cessation intervention designed for adolescents and young adults aged 16-25. It is hypothesized that municipals using the intervention will recruit more youths to their cessation activities, feel more confident in counseling the youths and experience higher abstinence rates compared to control municipalities continuing "as usual".

Interventions

The intervention consists of three elements: A) training of counselors who assist young smokers and nicotine procuct users to quit ("Training"), B) A strategy to recruit adolescents and young adults to tobacco and nicotine cessation services ("Recruitment"), and C) A tobacco and nicotine cessation couse for adolescents and young adults ("Cessation"). A. Training Training in the recruitment strategy is delivered on a 1-day course. Guidance is offered on how to engage with youths (a face-to-face

The intervention consists of three elements: A) training of counselors who assist young smokers and nicotine procuct users to quit ("Training"), B) A strategy to recruit adolescents and young adults to tobacco and nicotine cessation services ("Recruitment"), and C) A tobacco and nicotine cessation couse for adolescents and young adults ("Cessation"). A. Training Training in the recruitment strategy is delivered on a 1-day course. Guidance is offered on how to engage with youths (a face-to-face interaction with youth in classes or at their workplace, sports club, campus, etc.) and how to motivate them to participate in the course. A video and posters with young peers (role models) and their reflections on smoking/nicotine use and wish to quit are provided. The youth counselor training is delivered on a 2-day course. The youth counselor training program is aimed at both experienced smoking cessation counselors but also at persons who e.g., have a pedagogical background but never have worked with smoking cessation. The focus is on relational and resource-oriented behavioral techniques, knowledge on nicotine addiction as well as on how to motivate youths to quit tobacco and nicotine and how to prevent relapse. The program focuses on a nonjudgmental and supportive approach. The training also gives a basic knowledge of novel tobacco and nicotine products and their harmful effects. Training will be completed at least 1 month prior to recruitment of young persons. B. Recruitment The municipalities are fully responsible for recruiting participants for their tobacco and nicotine cessation activities. As part of the intervention, municipalities randomized into the intervention group will receive free recruitment materials and guidance on how to recruit. The recruitment strategy is developed as a step-by-step guidance on where to recruit and how to contact youth arenas for recruitment (i.e., schools, workplaces, fitness centers, sports clubs, campuses, barracks, and meeting places for youth) as well as how to encourage them to cooperate. Guidance is given on how to maintain and expand the recruitment strategy in different youth arenas over time. A video and letters aimed at leaders/heads of the arenas are provided. C. Cessation The tobacco and nicotine cessation course takes place in the youth arena; therefore, arenas must provide premises where the course can take place. The aim of the course is complete abstinence (not reduction) from all tobacco and nicotine products (not switching to other products). The course consists of seven meetings planned over eight weeks. The sessions last between 1.5 hours and 45 minutes and will be delivered by counselors that have completed the training (explained in point A). The first three sessions focus on motivation building and preparation for the target quit date between the third and fourth sessions. The four sessions planned after the quit date are focused on how to deal with the cravings and symptoms of abstinence and keeping up the motivation to stay nicotine-free. Approximately twelve young people are recruited to a group. The course will be conducted verbally with physical materials specially designed for the course (pictures, mindfulness exercises etc.).

Sponsors

Charlotta Pisinger - Center for Clinical Research and Prevention
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
16 Years to 25 Years
Healthy volunteers
No

Inclusion criteria

16-25 years old, using at least one tobacco- or nicotine product, and motivated to participate in cessation counseling.

Exclusion criteria

None.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026