University of California San Francisco
San Francisco, California, 94143, United States
NCT Number: NCT05227027
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
San Francisco, California, 94143, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
None
Receive access to the the game module through the free, 'Smoke Free' smartphone application
Other names: In-application game module
Receive educational intervention through the free 'Smoke Free' smartphone application (core version of the app)
Other names: Educational intervention
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
University of California, San Francisco
Other
Influence of a Game Embedded in a Smartphone App for Smoking Cessation on User Engagement: A Randomized Pilot Trial
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.
Published trials that share one or more normalized conditions with this study.
NCT06038526
Cigarette Smoking-Related Carcinoma, Lung Carcinoma
Columbus, Ohio, United States
View Trial DetailsNCT05825001
Cigarette Smoking-Related Carcinoma
Buffalo, New York, United States
View Trial DetailsNCT06230159
Cigarette Smoking-Related Carcinoma
Columbus, Ohio, United States
View Trial DetailsNCT03856515
Cigarette Smoking-Related Carcinoma
Houston, Texas, United States
View Trial Details