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Smoking CessationNCT06675526

Detour: a Smartphone Game to Help Youth Quit Smoking

A study testing Detour and Self-help brochure in people with Smoking Cessation and Smoking Reduction, run by Behavioural Science Institute at 1 site in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The researchers are testing a mobile game (named Detour) to support smoking cessation in adolescents and young adults (16-25 years). The game will be tested in a randomized-controlled trial (RCT) where Detour is tested against a digital self-help brochure ("Jouw eigen plan om te stoppen met roken" [in English: Your… Read more about this study

Who is it for?
Ages 16 to 25 years
What is being tested?
Detour and Self-help brochure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
604 participants
Where
1 siteNetherlands
Study dates
5 Jul 2024to 31 Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • aged 16 to 25 years
  • smokes at least weekly
  • motivated to quit smoking (participants should answer "misschien", "waarschijnlijk" or "heel erg" to the question are you motivated to quit smoking at this specific moment?).
  • installed Detour application; only applicable for participants assigned to the game intervention group.

Who cannot join

  • younger than 16 or older than 25
  • smoke less than once a week
  • not motivated to quit smoking are not eligible for this study i.e. participants who answered "helemaal niet"/"not at all") or "onwaarschijnlijk"/"unlikely" to the question are you motivated to quit smoking at this specific moment?).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Maartje Luijten, PhD contact

+31 647949807

maartje.luijten2@ru.nl

Hanneke Scholten, PhD contact

+31 623721158

h.scholten@erasmusmc.nl

Netherlands1 site, 1 recruiting
  • Radboud University

    Nijmegen, Gelderland, 6525 GD

    Suhaavi Kochhar, MSc, +31 644272424, s.kochhar@ru.nl

    Renee Roosen, BSc, +31 640730767, renee.roosen@ru.nl

    Recruiting

Other trials in Netherlands

About this study

The researchers are testing a mobile game (named Detour) to support smoking cessation in adolescents and young adults (16-25 years). The game will be tested in a randomized-controlled trial (RCT) where Detour is tested against a digital self-help brochure ("Jouw eigen plan om te stoppen met roken" [in English: Your personal plan to quit smoking]) as the active control group. The researchers will recruit 604 participants (aged 16-25) and randomly assign them to receive the game or brochure intervention. The duration between pre-test and post-test for both groups is 5 weeks during which participants can access (parts of) their respective intervention. All participants quit smoking at the end of week 1 of the intervention period. Data is collected on smoking behaviour, intervention usage, and emotional well-being.

Read the detailed description

The aim of the present two-armed randomized controlled trial is to test the efficacy of Detour, a smartphone game to help youth (16-25 years) quit smoking. It is designed to be an accessible, multi-component intervention providing in-the-moment distractions from cravings. First, Detour targets stimuli devaluation using a gamified go/no-go training in an endless runner game format. Second, the researchers aimed to reduce delay discounting in two ways; 1) players can replace neutral images in the go/no-go training with positive images from their own lives related to their future self; 2) players can set and monitor personal goals via the game, to promote future-self priming. Third, participants join a social shell comprising Instagram and TikTok content to provide psychoeducation about quitting smoking and to interact with fellow players who quit simultaneously. Finally, the timing and content of in-game messaging is personalized to each participant based on information provided in an ecological momentary assessment component and a stop plan filled out during the week before the quit attempt.

Detour will be tested against a self-help digital brochure, "Jouw eigen plan om te stoppen met roken" by the Trimbos Institute, the Netherlands. The brochure provides guidelines to independently design a stop-plan including questions about seeking support from others, strategies to fight cravings, and setting rewards for milestones after quitting. Additionally, the brochure has psychoeducational information that is valuable when planning to quit smoking.

For the data collection procedure, the researchers will first broadly distribute a short screening questionnaire via educational institutes and social media to assess study inclusion criteria. Eligible participants will be contacted by phone/text message/email to explain the purpose of the study further and invited to fill out the pre-test measurement if they would like to participate. The researchers will recruit nationwide and strive for a diverse sample in terms of gender, demographic location and educational levels. Participants will provide informed consent at both the screening and pre-test phases.

After the pre-test, blocks of 6 participants are randomly assigned to either the "Detour" game group or the brochure group to begin the intervention. The intervention period lasts for five weeks. During week 0 or the preparatory week, participants can access Detour or the brochure but have not yet quit. On day 1 of week 1, known as quit day, participants will quit smoking and try to remain smoke-free for the next four weeks (weeks 1-4).

The target sample size is N = 604, with 10% drop-outs taken into account. Recruitment will stop once 604 participants have received an intervention or on August 1, 2025.

The aim is to achieve 25% abstinence rates at 6-month follow-up in the game group. The researchers aim to prove a small effect size (odds ratio 1.88) with 90% power. A power analysis (logistic regression analysis, one-tailed alpha .05, and a fifty-fifty distribution of participants in both groups) showed that they will need N = 604 participants, taking into account a 10% loss.

To assess the immediate effectiveness of the game for smoking cessation in youth, logistic regression analyses will be performed with intervention group (game or brochure), as predictor and 14-day point prevalence of smoking abstinence (yes/no) at 6-month follow-up as the outcome. Age, Gender, socioeconomic status (SES), and baseline weekly smoking will be added to the model as controlled variables.

To assess the longer-term effectiveness of the game for smoking cessation in youth, logistic regression analyses will be performed with intervention group (game or brochure), as predictor and 14-day point prevalence of smoking abstinence (yes/no) at post-test as the outcome. Age, Gender, socioeconomic status (SES), and baseline weekly smoking will be added to the model as controlled variables.

To assess the effect of the game on weekly smoking, multilevel regression analysis will be performed with intervention group (game or brochure), time (pre-test, post-test, 3-month follow-up and 6-month follow-up), and their interaction as predictors, and weekly smoking as the outcome. The following models will be tested. Age, Gender, socioeconomic status (SES), and baseline weekly smoking will be added to the model as controlled variables.

  • Model0 ← WeeklySmoking ~ (1 | ID); check intra-class correlations
  • Model1 ← WeeklySmoking ~ TreatmentGroup + Time + Gender + Age + SES + Baseline weekly smoking + (1 | ID)
  • Model2 ← WeeklySmoking~ TreatmentGroup + Time + Gender + Age + SES + Baseline weekly smoking + (1 + time | ID); compare model 1 and model 2 to see if random slopes give better model fit.
  • Model3 ← WeeklySmoking~ TreatmentGroup + Time + TreatmentGroup:Time + Gender
  • Age + SES + Baseline weekly smoking + (1 + time | ID); Calculate simple slopes for both cases of treatment group.

For the analyses of the primary and secondary outcomes, a one-tailed p < .05 criteria will be used. For remaining analyses the standard p < .05 criteria will be used.

Furthermore, the intention to treat approach will be used, where it is assumed that people who missed post-test or either follow-up are non-abstinent.

Participants who only responded to the pretest but neither post-test, 3-month follow-up, nor 6-month follow-up will be considered as relapsers in analyses with abstinence as the outcome. In models with weekly smoking as the outcome, the majority of weekly smoking values would need to be imputed, so instead participants who only responded to the pre-test measure will be excluded.

The present pre-registration only pertains to the efficacy of the intervention. A follow-up registration on the in-depth analysis of the intervention effects and sub-group analyses to test who the intervention worked best for will be made. Please refer to the project page for more information (https://osf.io/k784a/).

Being tested
Detour, Self-help brochure
Keywords
Behaviour change, Game intervention, Peer influence, Smoking cessation, Youth
Medical subject headings
Smoking Cessation, Smoking Reduction, Adolescent Behavior, Social Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DetourBehavioural

    "Detour" is a mobile game designed to assist youth with smoking cessation. First, Detour targets stimuli devaluation using a gamified go/no-go training. Second, the researchers aimed to reduce delay discounting in two ways; 1) players can replace neutral images in the go/no-go training with positive images from their own lives related to their future self; 2) players can set and monitor personal goals via the game, to promote future-self priming. Third, participants join a social shell comprising Instagram and TikTok content to provide psychoeducation about quitting smoking and to interact with fellow players who quit simultaneously. Finally, the timing and content of in-game messaging is personalized to each participant based on information provided in an ecological momentary assessment component and a stop plan filled out during the week before the quit attempt.

  • Self-help brochureBehavioural

    The brochure provides guidelines to independently design a stop-plan including questions about seeking support from others, strategies to fight cravings, and setting rewards for milestones after quitting. Participants will be encouraged to complete this stop-plan in week 0 of the intervention, so the week before quit day. Additionally, the brochure includes psychoeducational information that is valuable when planning to quit smoking.

Study groups in NCT06675526
Study groupRoleWhat they receive
DetourExperimentalParticipants have access to Detour for 5 weeks encompassing various elements: (1) Completing a stop plan during the initial week preceding the quit attempt. (2) Engaging in ecological momentary assessments, measuring affect, nicotine withdrawal, and smoking behavior during the first two weeks: one week prior to and one week post quit attempt. (3) Accessing the game for a duration of 4 weeks following the quit attempt. (4) Participating in the social shell, in which participants join private social media channels on Instagram and/or TikTok for the entirety of the intervention period.
Receives: Behavioral: Detour
Digital self-help materialActive comparatorParticipants receive a self-help digital brochure, "Jouw eigen plan om te stoppen met roken" for smoking cessation in the control group. They will read this on personal demand.
Receives: Behavioral: Self-help brochure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Smoking abstinence

    The primary outcome measure will be 14-day point prevalence abstinence (yes/no) at six month follow-up i.e. 6 months from quit date.

    Measured: 6 month follow-up

Secondary outcomes (2)
  1. Smoking abstinence

    The primary outcome measure will be 14-day point prevalence abstinence (yes/no) at post test immediately after the 5-week intervention period.

    Measured: immediate post-test after 5-week intervention period

  2. Weekly smoking

    Weekly smoking behavior will be assessed with two questions 1) "How many days per week do you smoke on average?" and "On a day that you smoke, how many cigarettes do you smoke on average?". Weekly smoking behaviour will be assessed at pre-test within the week before the intervention begins, at immediate post-test after 5-week intervention period, at 3-month follow-up from quit date, and at 6-month follow-up from quit date. The answers to these questions will be multiplied to come to a single measure of weekly smoking. If participants remain abstinent, weekly smoking will be set to 0.

    Measured: pre-test, immediate post-test after 5-week intervention period, 3-month follow-up, and 6-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2024
  2. Study start5 Jul 2024
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A two-armed RCT (Detour vs digital self-help material to quit smoking as the control group) will be conducted to test the efficacy of Detour. All participants fill out Qualtrics questionnaires comprising self-report measures at screening, pre-test, post-test, 3-month follow-up, and 6-month follow-up. In addition, participants in the game group answer some questions in the mobile application, participant in-game behaviour (such as time spent playing) is measured, and text-data from the player chat room and social shell will be used.
Masking
None (open label)
Enrolment
604 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06675526
Sponsor's protocol ID
Detour
Other IDs
12946, KA154-YOU-000100302
Status last verified
Nov 2024
First submitted
4 Jul 2024
Last updated
8 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The researchers will share the data and analytic code in OSF and via SURFdrive, following their institute's policy.

Questions about this trial

What is this clinical trial studying?

A study testing Detour and Self-help brochure in people with Smoking Cessation and Smoking Reduction, run by Behavioural Science Institute at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maartje Luijten, PhD (+31 647949807, maartje.luijten2@ru.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Smoking abstinence (time frame: 6 month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.

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