Clinical trial NCT05624489: Micro-Randomized Trial to Optimize Digital Oral Health Behavior Change Interventions
Official title: Personalized Digital Behavior Change Interventions to Promote Oral Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Diseases
Keywords: Dental disease
Health Behavior Change
Oral Self Care Behaviors
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2022-11-22
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Proximal adherence to 2x2x4 OHB
timeFrame: 24 hours
Secondary outcomes:
measure: Proximal mHealth engagement
timeFrame: 24 hours
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Vivek Shetty
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.