search
Back to results

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

Primary Purpose

Dental Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Engagement Strategies
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Diseases focused on measuring Dental disease, Health Behavior Change, Oral Self Care Behaviors

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of California, Los Angeles

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Proximal adherence to 2x2x4 OHB
Change in proximal OHB score between the current and next randomization

Secondary Outcome Measures

Proximal mHealth engagement
Engagement with Oralytics app (i.e., accessing the Oralytics app or clicking on the push notification) between the current and next randomization.

Full Information

First Posted
November 14, 2022
Last Updated
November 21, 2022
Sponsor
University of California, Los Angeles
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
search

1. Study Identification

Unique Protocol Identification Number
NCT05624489
Brief Title
Micro-Randomized Trial to Optimize Digital Oral Health Behavior Change Interventions
Acronym
DCBI
Official Title
Personalized Digital Behavior Change Interventions to Promote Oral Health
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2023 (Anticipated)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Diseases
Keywords
Dental disease, Health Behavior Change, Oral Self Care Behaviors

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Engagement Strategies
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proximal adherence to 2x2x4 OHB
Description
Change in proximal OHB score between the current and next randomization
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Proximal mHealth engagement
Description
Engagement with Oralytics app (i.e., accessing the Oralytics app or clicking on the push notification) between the current and next randomization.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vivek Shetty
Phone
3108255170
Email
vshetty@g.ucla.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Zara Greer
Phone
424 228 8165
Email
zgreer@mednet.ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vivek Shetty
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1668
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zara Greer
Phone
323-716-3327
Email
zgreer@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Vivek Shetty
Phone
310 825 5170
Email
vshetty@mednet.ucla.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
A de-identified dataset will be generated and made available to the research community. The dataset will be stripped of all codes or any other information that could be linked back to the original data or an individual participant. Prospective users of this dataset must agree to a confidentiality agreement and get permission from the Primary Investigator to use or share the data with anyone else. All external requests for data will be directed to 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.
IPD Sharing Time Frame
12 months after publication of primary analyses.
IPD Sharing 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.

Learn more about this trial

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

We'll reach out to this number within 24 hrs