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

NCT05624489 | Completed

• 2 other identifiers: IRB#21-001471UG3DE028723
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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).

Conditions

Dental Diseases

Keywords

Dental disease; Health Behavior Change; Oral Self Care Behaviors

Outcome Measures

Primary Outcomes (1)

• Proximal adherence to 2x2x4 OHB

  Change in proximal OHB score between the current and next randomization

  24 hours

Secondary Outcomes (1)

• Proximal mHealth engagement

  24 hours

Study Arms (1)

Intervention

EXPERIMENTAL

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.

Behavioral: Engagement Strategies

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095-1668, United States

Location

Related Publications (1)

• 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.

  PMID: 38307224 BACKGROUND

MeSH Terms

Conditions

Stomatognathic Diseases

Study Officials

• Vivek Shetty

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: November 22, 2022
• Study Start: February 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: February 1, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 12 months after publication of primary analyses.
• Access Criteria: All external requests for data will be directed to the PI (Dr. Vivek Shetty). Prospective investigators will submit a written proposal to the PI outlining the question they will investigate, the specific variables that they need to answer that question, their analytic plan for answering that question, and documentation of sufficient Institutional Review Board oversight (e.g., approval or exemption). Investigators will also need to sign a confidentiality agreement.

Locations

US (1)