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Completed

NCT Number: NCT05227027

Pilot Trial of a Game Embedded in a Smartphone App for Smoking Cessation

This study evaluates the effects of a video game embedded in a commercially available mobile application (app) for smoking cessation. Smokers are increasingly turning to mobile health apps for assistance with quitting smoking, and there is a critical need for strategies to engage app users to increase retention and efficacy. Video games are designed to increase users' motivation and engagement, which in turn may increase their exposure and adherence to a smoking cessation program. The hypothesis is that the game increases engagement, retention, and smoking abstinence rates compared with a core version of the app without the game. A two-arm individually randomized pilot trial of 500 adult smokers will test this hypothesis, comparing outcomes for participants randomized to receive the core app plus embedded game with participants randomized to receive the core app only. Primary outcomes relate to user engagement with the app. Secondary outcomes relate to user engagement, efficacy (smoking abstinence), and user satisfaction.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Francisco

San Francisco, California, 94143, United States

About this study

PRIMARY OBJECTIVES:

I. Augment an existing smartphone cessation app for smoking cessation with a video game to increase user engagement.

II. Test the feasibility, engagement, and early efficacy of the 'gamified' app, compared to one without gamification.

OUTLINE:

Participants are recruited through the Smoke Free smartphone app and randomized to 1 of 2 arms.

ARM I: Participants receive an educational intervention through the Smoke Free application (core app) with the embedded video game module. Participants complete questionnaires and may undergo saliva sample collection, if they report being smoke-free on follow-up.

ARM II: Participants receive an educational intervention through the Smoke Free application without the video game module (core app only). Participants complete questionnaires and may undergo saliva sample collection, if they report being smoke-free on follow-up.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provides electronic informed consent.
  • Male or female, aged 18 and older
  • Has downloaded and opened the Smoke Free app
  • A smoker of at least 1 cigarette per day
  • Plans to quit smoking within the next 7 days
  • Speaks, reads, and writes English
  • Lives in the United States

Exclusion criteria

None

Treatment and study plan

Game Module

Behavioral

Receive access to the the game module through the free, 'Smoke Free' smartphone application

Other names: In-application game module

Smoke Free smartphone application

Behavioral

Receive educational intervention through the free 'Smoke Free' smartphone application (core version of the app)

Other names: Educational intervention

Primary outcomes

  1. Number of Unique App Sessions

    Time frame: Enrollment through 56 days after participant's selected quit date (56 to 63 days total)

    Number of times the app was opened; passively collected by the app and averaged in analysis to calculate mean number of app opens by study group over the study period. A new session is defined as use of the app after at least 30 minutes of inactivity.

  2. Minutes of App Usage Per Session

    Time frame: Enrollment through 56 days after participant's selected quit date (56 to 63 days total)

    Passively collected by the app and averaged in analysis among those with a session to calculate mean number of minutes of usage per session by study group.

Secondary outcomes

  1. Unique Days With at Least One App Session

    Time frame: Enrollment through 56 days after participant's selected quit date (56 to 63 days total)

    Number of unique days with at least one app session, passively collected by the app and averaged by study group.

  2. Self-reported 7-day Point-prevalence Abstinence at 2 Months

    Time frame: 56 days after participant's selected quit date (56 to 63 days after enrollment)

    Proportion of participants who self-report having abstained for the prior 7 days during the 2-month follow-up assessment, assuming missing = smoking.

  3. Self-reported 30-day Point-prevalence Abstinence at 2 Months

    Time frame: 56 days after participant's selected quit date (56 to 63 days after enrollment)

    Proportion of participants who who self-report having abstained for the prior 30 days during the 2-month follow-up assessment, assuming missing = smoking.

  4. Satisfaction With App

    Time frame: 56 days after participant's selected quit date (56 to 63 days after enrollment)

    Rating of satisfaction with assigned app on a 5-point Likert scale from "Not at all" (1) to "Extremely" (5), assessed in the 2-month follow-up questionnaire. The measure is averaged by study group.

  5. Satisfaction With Game (Intervention Group Only)

    Time frame: 56 days after participant's selected quit date (56 to 63 days after enrollment)

    Rating of satisfaction with the game on a 5-point Likert scale from "Not at all" (1) to "Extremely" (5), assessed in the 2-month follow-up questionnaire. The measure is averaged for the intervention group.

Other outcomes

  1. Biochemically Verified 7-day Point-prevalence Abstinence at 2 Months

    Time frame: 56 days after participant's selected quit date (56 to 63 days after enrollment)

    Proportion of participants who who self-report having abstained for the prior 7 days during the 2-month follow-up assessment, verified by saliva cotinine test, assuming missing = smoking. Averaged by study group. Recoded to 0 if the person reported having smoked during the same 7-day window during repeated measurement of daily smoking in the app.

  2. Biochemically Verified 30-day Point-prevalence Abstinence at 2 Months

    Time frame: 56 days after participant's selected quit date (56 to 63 days after enrollment)

    Proportion of participants who who self-report having abstained for the prior 30 days during the 2-month follow-up assessment, verified by saliva cotinine test, assuming missing = smoking. Averaged by study group. Recoded to 0 if the person reported having smoked during the same 30-day window during repeated measurement of daily smoking in the app.

  3. Repeated 1-day Point-prevalence Smoking Abstinence

    Time frame: During the 56 days after participant's selected quit date

    Proportion of days in which participants self-report having abstained in the last 24 hours, collected via a pop-up box that appears the first time each day a participant opens the app. Averaged by study group.

  4. Program Adherence (Index of Core Feature Use)

    Time frame: Enrollment through 56 days after participant's selected quit date (56 to 63 days total)

    Number of non-game (core app) activities completed in the app by activity type: passively collected by the app to assess number of times the participant completed the following activity types: reported a craving, recorded a diary, completed a mission, read a tip, used the chatbot.

  5. Gifts Unlocked (Intervention Group Only)

    Time frame: Enrollment through 56 days after participant's selected quit date (56 to 63 days total)

    Number of in-game gifts unlocked during the study period (intervention group only); a summary measure of intensity of engagement (dose of treatment) of the app; passively collected by the app.

  6. Game Activities (Intervention Group Only)

    Time frame: Enrollment through 56 days after participant's selected quit date (56 to 63 days total)

    Number of game activities completed in the app by activity type; passively collected by the app to assess number of times the participant completed the following activity types: navigated to the game dashboard, completed each pet care activity (breathing exercise, feeding, washing, memory mini-game), visited the park, entered the dragon guide.

  7. Recommends App to Friend

    Time frame: 56 days after participant's selected quit date (56 to 63 days after enrollment)

    Rating of whether would recommend assigned app to a friend on a 5-point Likert scale from "Not at all" (1) to "Extremely" (5), assessed in the 2-month follow-up questionnaire. The measure is averaged by study group.

  8. Motivation to Quit

    Time frame: 56 days after participant's selected quit date (56 to 63 days after enrollment)

    Motivation to quit, reported on a 10-point scale from not at all motivated (0) to very unmotivated (10) and assessed in the 2-month follow-up.

  9. Digital Therapeutic Alliance

    Time frame: 56 days after participant's selected quit date (56 to 63 days after enrollment)

    The measure includes items from the Bonding and Confidence subscales from the Mobile Agnew Relationship Measure, a scale of digital therapeutic alliance. Two items from each of the Bonding and Confidence subscales were included. Each item was asked on a 4-point Likert scale from strongly disagree (1) to strongly agree (4). The subscale items were combined to give a total possible score of 16 and a range of 4 (low alliance) to 16 (high alliance). The measure is averaged by study group. Assessed in the 2-month follow-up.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Johns Hopkins University
  • National Cancer Institute (NCI)
  • National Institute on Aging (NIA)
  • University of California, Berkeley

Registry information

Official study title

Influence of a Game Embedded in a Smartphone App for Smoking Cessation on User Engagement: A Randomized Pilot Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 7, 2022
Registry last updated
Jan 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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