Micro-Randomized Trial to Optimize Digital Oral Health Behavior Change Interventions

Not Applicable

Completed

• Conditions: Dental Diseases
• Interventions: Behavioral: Engagement Strategies

• Registration Number: NCT05624489
• Lead Sponsor: University of California, Los Angeles

Brief Summary

The study will involve a 10-week Micro-Randomized Trial (MRT) to inform the delivery of prompts (via mobile app push notifications) designed to facilitate adherence to an ideal tooth brushing protocol (2x2x4; 2 sessions daily, 2 minutes per session, all 4 quadrants).

Detailed Description

The goal of the MRT is to investigate whether delivering (vs. not delivering) a prompt that contains engagement strategies grounded in decision science is beneficial in terms of promoting proximal oral health behavior (OHB) score, which reflects adherence to the 2x2x4 brushing protocol (Primary Aim) and also mobile health engagement (mHealth; Secondary Aim). Additionally, Exploratory Aims will concern (a) comparing different types of prompts in terms of proximal OHB score and mHealth engagement, (b) investigating the conditions in which prompts should be delivered to most effectively promote proximal OHB and mHealth engagement; and (c) investigating whether the effect of the engagement prompts (vs. no prompt) on OHB score varies across components of the 2x2x4 brushing regimen (i.e., frequency, duration, or coverage).

Participants will receive an electronic toothbrush (eBrush) and a mobile app (Oralytics) that contains well-established behavior change strategies (e.g., goal setting, monitoring adherence, and feedback). Participants will be randomized twice per day - in the morning and the evening - to receive either (a) a push notification containing one of three (randomly selected) engagement strategies or (b) no notification.

During the 10 weeks of the study, a Bayesian algorithm will iteratively adjust the probability of receiving a prompt or no prompt in any given randomization window, using prior behavioral data collected through the eBrush and mobile app. Data patterns suggesting positive effects of the prompts on adherence to brushing protocol, especially duration, will result in higher subsequent probabilities of receiving the prompts, whereas patterns suggesting null or negative effects will result in lower probabilities of receiving the prompts.

Study results will inform the implementation of a smartphone-delivered behavior change intervention that further adapts the delivery of engagement prompts based on passively collected information from an eBrush and the mobile app.

Study Timeline

• Study First Submitted: 2022-11-14
• Study First Submitted QC: 2022-11-14
• Study First Posted: 2022-11-22
• Study Start: 2023-02-01
• Primary Completion: 2024-06-30
• Study Completion: 2025-02-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

• Adults, age 18 or older.
• Fluent in English
• Dentulous/partially edentulous (18+ teeth; at least 2 teeth in each quadrant)
• Possess a smartphone (iOS or Android) with a data plan.
• Willing to allow the passive collection of data on tooth-brushing activities in the home setting for 10 weeks.

Exclusion Criteria

• Not fluent in English
• Edentulous
• Unable to use a mobile device due to cognitive or physical impairments

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Engagement Strategies	Each participant-time point will be randomized between a prompt containing an engagement strategy vs. no prompt. A Bayesian algorithm will iteratively adjust the probability of receiving a prompt or no prompt at any time point, using brushing behavior data. Patterns suggesting positive effects of the prompts on brushing adherence will result in higher subsequent probabilities of receiving the prompts, whereas patterns suggesting null or negative effects will result in lower probabilities of receiving the prompts. A participant is assigned to an engagement prompt will be randomized equally between the three types of engagement strategies: (1) Standard reciprocity prompt: delivering non-contingent reward points as a "gift" to support goals; (2) Reciprocity by proxy prompt: delivering a message indicating a donation to the person's selected charity; (3) Curiosity prompt: delivering oral health information in a manner that motivates the participant to seek new knowledge and information.

Primary Outcome Measures

Name	Time	Method
Proximal adherence to 2x2x4 OHB	24 hours	Change in proximal OHB score between the current and next randomization

Secondary Outcome Measures

Name	Time	Method
Proximal mHealth engagement	24 hours	Engagement with Oralytics app (i.e., accessing the Oralytics app or clicking on the push notification) between the current and next randomization.

Trial Locations

Locations (1)

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States