Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001470583
Ethics application status
Approved
Date submitted
11/10/2024
Date registered
18/12/2024
Date last updated
18/12/2024
Date data sharing statement initially provided
18/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 313170 0
TrygFonden ID: 178385
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nicotine addiction 335454 0
Tobacco addiction 335715 0
Condition category
Condition code
Public Health 332015 332015 0 0
Health promotion/education
Mental Health 332281 332281 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.).
Intervention code [1] 329744 0
Treatment: Other
Intervention code [2] 329745 0
Prevention
Comparator / control treatment
The municipalities in the control group will continue their recruitment practices and their youth cessation activities "as usual" (at the time of randomization there was great variation in the practices and activities). The control municipalities can offer individual or group-based counseling, of any duration. The "usual care" is counseling based on experiencesed with adult smokers and are typically not designed or relevant for young people that are not only smoking but also using other tobacco- and nicotine products. Some control municipalities were, at the time of randomization, very active in recruiting and counseling young people to quit the use of tobacco and nicotine, while other municipalities are not recruiting young people and do not offer cessation assistance for youths.
Control group
Active

Outcomes
Primary outcome [1] 339617 0
A) Recruitment numbers
Timepoint [1] 339617 0
Follow-up 3 (12 months post the start of the intervention year)
Primary outcome [2] 339853 0
B) counselor competences
Timepoint [2] 339853 0
Follow-up (12-months post the start of the intervention year)
Primary outcome [3] 339854 0
C) quit rates among youths.
Timepoint [3] 339854 0
Baseline, follow-up 1 (4 weeks post target quit date), follow-up 2 (6 months post target quit date).
Secondary outcome [1] 440628 0
Acceptability of the intervention programme.
Timepoint [1] 440628 0
Follow-up 3 (12 months post start of the intervention year)
Secondary outcome [2] 441655 0
Feasibility during implementation.
Timepoint [2] 441655 0
Follow-up 3 (12 months post start of the intervention year)

Eligibility
Key inclusion criteria
16-25 years old, using at least one tobacco- or nicotine product, and motivated to participate in cessation counseling.
Minimum age
16 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software. Stratification: municipal size and inter-municipal cooperation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
605
Accrual to date
Final
Recruitment outside Australia
Country [1] 26630 0
Denmark
State/province [1] 26630 0

Funding & Sponsors
Funding source category [1] 317613 0
Charities/Societies/Foundations
Name [1] 317613 0
TrygFonden
Country [1] 317613 0
Denmark
Primary sponsor type
Individual
Name
Charlotta Pisinger - Center for Clinical Research and Prevention
Address
Country
Denmark
Secondary sponsor category [1] 320130 0
None
Name [1] 320130 0
None
Address [1] 320130 0
Country [1] 320130 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316317 0
Danish National Scientific Ethics Commitee
Ethics committee address [1] 316317 0
Ethics committee country [1] 316317 0
Denmark
Date submitted for ethics approval [1] 316317 0
01/07/2024
Approval date [1] 316317 0
19/08/2024
Ethics approval number [1] 316317 0
F-24044815

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137506 0
Mrs Charlotta Pisinger
Address 137506 0
Center for Clinical Research and Prevention, Nordre Fasanvej 57, 2000 Frederiksberg, Denmark
Country 137506 0
Denmark
Phone 137506 0
+4538163017
Fax 137506 0
Email 137506 0
[email protected]
Contact person for public queries
Name 137507 0
Charlotta Pisinger
Address 137507 0
Center for Clinical Research and Prevention, Nordre Fasanvej 57, 2000 Frederiksberg, Denmark
Country 137507 0
Denmark
Phone 137507 0
+4538163017
Fax 137507 0
Email 137507 0
[email protected]
Contact person for scientific queries
Name 137508 0
Charlotta Pisinger
Address 137508 0
Center for Clinical Research and Prevention, Nordre Fasanvej 57, 2000 Frederiksberg, Denmark
Country 137508 0
Denmark
Phone 137508 0
+4538163017
Fax 137508 0
Email 137508 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.