NCT06675526

Brief 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" \[in English: Your personal plan to quit smoking\]) 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
604

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Jul 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Jul 2024Aug 2026

First Submitted

Initial submission to the registry

July 4, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

July 5, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 5, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Expected
Last Updated

November 8, 2024

Status Verified

November 1, 2024

Enrollment Period

1.5 years

First QC Date

July 4, 2024

Last Update Submit

November 7, 2024

Conditions

Keywords

Behaviour changeGame interventionPeer influenceSmoking cessationYouth

Outcome Measures

Primary Outcomes (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.

    6 month follow-up

Secondary Outcomes (2)

  • Smoking abstinence

    immediate post-test after 5-week intervention period

  • Weekly smoking

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

Study Arms (2)

Detour

EXPERIMENTAL

Participants 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.

Behavioral: Detour

Digital self-help material

ACTIVE COMPARATOR

Participants 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.

Behavioral: Self-help brochure

Interventions

DetourBEHAVIORAL

"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.

Detour

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.

Digital self-help material

Eligibility Criteria

Age16 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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?).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University

Nijmegen, Gelderland, 6525 GD, Netherlands

RECRUITING

MeSH Terms

Conditions

Smoking CessationSmoking ReductionAdolescent BehaviorSocial Behavior

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSmoking

Study Officials

  • Maartje Luijten, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maartje Luijten, PhD

CONTACT

Hanneke Scholten, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2024

First Posted

November 5, 2024

Study Start

July 5, 2024

Primary Completion

December 31, 2025

Study Completion (Estimated)

August 31, 2026

Last Updated

November 8, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

The researchers will share the data and analytic code in OSF and via SURFdrive, following their institute's policy.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Once the associated paper is published, anonymised data will be made openly available via the project page on OSF (https://osf.io/k784a/) with no end date.

Locations