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Completed

NCT Number: NCT05624489

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

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).

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Los Angeles

Los Angeles, California, 90095-1668, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Engagement Strategies

Behavioral

The study's mobile app (Oralytics) will be used to deliver engagement prompts. The prompts contain messages that leverage three engagement strategies: reciprocity, reciprocity by proxy, and curiosity.

Primary outcomes

  1. Proximal adherence to 2x2x4 OHB

    Time frame: 24 hours

    Change in proximal OHB score between the current and next randomization

Secondary outcomes

  1. Proximal mHealth engagement

    Time frame: 24 hours

    Engagement with Oralytics app (i.e., accessing the Oralytics app or clicking on the push notification) between the current and next randomization.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Official study title

Personalized Digital Behavior Change Interventions to Promote Oral Health

Acronym: DCBI

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Nov 22, 2022
Registry last updated
Mar 21, 2025

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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