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

NCT ID: NCT05624489

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2025-02-01

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.

Conditions

Dental Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

Engagement Strategies

Intervention Type: 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.

Interventions

Engagement 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Vivek Shetty, DDS, DMD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vivek Shetty

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

University of California, Los Angeles

Los Angeles, California, United States

Countries

United States

References

Nahum-Shani I, Greer ZM, Trella AL, Zhang KW, Carpenter SM, Runger D, Elashoff D, Murphy SA, Shetty V. Optimizing an adaptive digital oral health intervention for promoting oral self-care behaviors: Micro-randomized trial protocol. Contemp Clin Trials. 2024 Apr;139:107464. doi: 10.1016/j.cct.2024.107464. Epub 2024 Feb 1.

Reference Type: BACKGROUND

PMID: 38307224 (View on PubMed)

Other Identifiers

UG3DE028723

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB#21-001471

Identifier Type: -

Identifier Source: org_study_id