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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-09

Study Completion Date

2022-05-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Cigarette Smoking-Related Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Education plus game module

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

Group Type EXPERIMENTAL

Game Module

Intervention Type BEHAVIORAL

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

Smoke Free smartphone application

Intervention Type BEHAVIORAL

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

Education module only

Participants receive an educational intervention through the Smoke Free application only (core app only). Participants complete questionnaires and may undergo saliva sample collection, if they report being smoke-free on follow-up.

Group Type ACTIVE_COMPARATOR

Smoke Free smartphone application

Intervention Type BEHAVIORAL

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

Interventions

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Game Module

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

Intervention Type BEHAVIORAL

Smoke Free smartphone application

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

Intervention Type BEHAVIORAL

Other Intervention Names

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In-application game module Educational intervention

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes