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Clinical Trials/NCT05624489
NCT05624489
Completed
N/A

Personalized Digital Behavior Change Interventions to Promote Oral Health

University of California, Los Angeles1 site in 1 country98 target enrollmentFebruary 1, 2023
ConditionsDental Diseases

Overview

Phase
N/A
Intervention
Not specified
Conditions
Dental Diseases
Sponsor
University of California, Los Angeles
Enrollment
98
Locations
1
Primary Endpoint
Proximal adherence to 2x2x4 OHB
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2023
End Date
February 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Vivek Shetty, DDS, DMD

Professor

University of California, Los Angeles

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

Outcomes

Primary Outcomes

Proximal adherence to 2x2x4 OHB

Time Frame: 24 hours

Change in proximal OHB score between the current and next randomization

Secondary Outcomes

  • Proximal mHealth engagement(24 hours)

Study Sites (1)

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