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

University of California San Francisco (UCSF)

Status: Completed

Conditions: Cigarette Smoking-Related Carcinoma

Treatments: Behavioral: Smoke Free smartphone application; Behavioral: Game Module

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05227027

R21CA238301 (U.S. NIH Grant/Contract)

NCI-2021-07004 (Registry Identifier)

P30AG012839 (U.S. NIH Grant/Contract)

19-29335

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 500 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Exclusion criteria: None

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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500 participants in 2 patient groups

Education plus game module

Experimental group

Description:

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.

Treatment:

Behavioral: Game Module

Behavioral: Smoke Free smartphone application

Education module only

Active Comparator group

Description:

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.

Treatment:

Behavioral: Smoke Free smartphone application