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

Personalized Digital Behavior Change Interventions to Promote Oral Health

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05624489
Acronym
DCBI
Enrollment
98
Registered
2022-11-22
Start date
2023-02-01
Completion date
2025-02-01
Last updated
2025-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Diseases

Keywords

Dental disease, Health Behavior Change, Oral Self Care Behaviors

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.

Interventions

BEHAVIORALEngagement Strategies

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.

Sponsors

National Institute of Dental and Craniofacial Research (NIDCR)
CollaboratorNIH
University of California, Los Angeles
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Each participant-time point (which will occur twice daily, in the morning and the evening) will be randomized between a prompt containing an engagement strategy vs. no prompt.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Proximal adherence to 2x2x4 OHB24 hoursChange in proximal OHB score between the current and next randomization

Secondary

MeasureTime frameDescription
Proximal mHealth engagement24 hoursEngagement with Oralytics app (i.e., accessing the Oralytics app or clicking on the push notification) between the current and next randomization.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026