BEhavioral EConomics for Oral Health iNnovation Trial (BEECON)

September 17, 2025 updated by: University of California, San Francisco

Influence of Financial Incentives on Oral Disease Management in Young Children

This Phase II stratified randomized prevention trial will assess the efficacy of a behavioral economic theory-based financial incentive drawing program versus a control regimen to promote early childhood caries (ECC) preventive health behaviors (toothbrushing performance) for young children of predominantly Latino parents/caregivers in Early Head Start (EHS) and day care center programs.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
244

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Monica, California, United States, 90405-1828
        • Venice Family Clinic Children First Early Head Start

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 months to 3 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Child

    • at least 2 fully erupted teeth
    • enrolled in, or waitlisted for, one of the participating Los Angeles County Early Head Start (EHS) or affiliated day care center or area clinic programs

  • Parent/caregiver

    • provide signed and dated informed consent form in English or Spanish
    • agree to comply with all study procedures and be available for the duration of the study
    • aged 18 or older
    • speak either English or Spanish and self-reported ability to read and write either English or Spanish
    • be a parent or caregiver of a child at least 6 months old but less than 4 years (48 months), with at least 2 fully erupted teeth and enrolled in, or waitlisted for, one of the participating Los Angeles County EHS or affiliated day care center or area clinic programs
    • not be planning to move residence for the next 18 months outside the greater Los Angeles area
    • own a smartphone with Google Play or iTunes store app and be willing to download and install the smart powered toothbrush app at the Screening visit and keep it installed for the duration of the project. [If the app cannot be properly installed by the baseline visit, the participant will not be randomized.]
    • be willing to be contacted via text-messaging (SMS) for study related notifications, such as incentives earned or reminders to sync the toothbrush

  • Stakeholder

    • be a staff member at a participating study site (e.g. EHS or affiliated day care center)
    • verbally agree to participate after being provided a study information sheet

Exclusion Criteria:

  • Child

    • known allergic reaction to components of the study product(s)
    • uncooperative or behaviorally unsuited (assessed during a toothbrush prophylaxis, ASTDD Basic Screening Survey caries screening, and photograph of maxillary incisors at the screening visit)
    • more than 2 crowns on maxillary incisor teeth (teeth# D, E, F, G, or equivalently #52, 51, 61, 62).
    • participated in the BEECON pilot trial
    • a sibling of a child enrolled in the study (the family's oldest child in the eligible age range will be the study child)
    • enrolled in foster care
    • anything else that would place him/her at increased health risk or preclude the individual's full compliance with or completion of the study

  • Parent/caregiver

    • participated in the BEECON pilot trial
    • unable or unwilling to install and use the smart powered toothbrush app during the run-in period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Incentive Drawing
Eligible to earn a weekly drawing entry with different winning probabilities during the 6-month incentive intervention period. Possible winnings depend on toothbrushing performance: low adherence threshold (brushing child's teeth once per day for 7 days in a week) will have an 18% chance of winning $25 and a 1% chance of winning $50 (expected $5 payout); high adherence threshold (brushing twice per day for 14 days in a week) will have a 34% chance of winning $25 and a 3% chance of winning $50 (expected $10 payout).
Behavioral: Drawing Incentive
The Monetary Reward intervention is a drawing reward, in which participants are eligible for weekly rewards based on toothbrushing performance.
No Intervention: Control - Delayed Incentive
No rewards during the first 12 months, but information on toothbrushing performance. After the Month 12 follow-up visit, may opt to participate in a delayed 6-month open label extension to earn the same monetary rewards the intervention group could earn Baseline through Month 6. Not a formal part of this trial, but rather a necessary condition to assure all participating parents/caregivers have the chance to earn the same monetary incentives.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Toothbrushing Performance
Time Frame: Baseline visit through the Month 6 visit
Mean of the number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth. (A Bluetooth-recorded toothbrushing episode qualifies if it lasts at least one minute within one of 14 half-day windows in the week.)
Baseline visit through the Month 6 visit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Short-term (Immediate) Toothbrushing Performance
Time Frame: Baseline visit through the Month 1 visit
Mean number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth.
Baseline visit through the Month 1 visit
Mid-term Toothbrushing Performance
Time Frame: Baseline visit through the Month 3 visit
Mean number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth.
Baseline visit through the Month 3 visit
Toothbrushing Performance Sustainability
Time Frame: Month 6 visit through the Month 12 visit
Mean number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth.
Month 6 visit through the Month 12 visit
Self-efficacy Scale
Time Frame: Month 6 visit
Caregiver (parent) oral health self-efficacy items (total score ranges 6-30 with higher score indicating more self-efficacy; 6 items each on 1-5 ordinal scale, Albino et al.; Finlayson et al.)
Month 6 visit
Modified Simplified Oral Hygiene Index
Time Frame: Month 6 visit and Month 12 visit
Debris Index of the Simplified Oral Hygiene Index for Maxillary Incisors (OHI-MIS) to measure child's plaque on primary maxillary incisor facial (labial) tooth surfaces (mean of 4 ordinal scores each with values ranging from no plaque (1) - which is best - to abundant plaque (4) - which is worst)
Month 6 visit and Month 12 visit
Change From Baseline in Toothpaste Weight
Time Frame: From Baseline to Month 6 visit and From Month 6 visit to Month 12 visit
Change in child's toothpaste pump weight (grams) from each distribution visit (6 months prior). Negative mean values are a decrease from an earlier time to a subsequent time.
From Baseline to Month 6 visit and From Month 6 visit to Month 12 visit
Untreated Caries
Time Frame: Month 6 visit and Month 12 visit
Number and percent of children with untreated caries using Association of State and Territorial Dental Directors Basic Screening Survey (ASTDD BSS) binary (yes/no) measure of child's untreated caries status (dt>0)
Month 6 visit and Month 12 visit
Caries Experience
Time Frame: Month 6 visit and Month 12 visit
Number and percent of children with any history of caries using Association of State and Territorial Dental Directors Basic Screening Survey (ASTDD BSS) binary (yes/no) measure of child's caries experience status (dmft>0)
Month 6 visit and Month 12 visit
Severe Caries
Time Frame: Month 6 visit and Month 12 visit
Number and percent of children with severe caries experience using Association of State and Territorial Dental Directors Basic Screening Survey (ASTDD BSS) binary (yes/no) measure of child's severe caries experience status (dmft>=4)
Month 6 visit and Month 12 visit
Past Year Dental Visit
Time Frame: Month 12 visit
Number and percent of children with a dental visit in the past 12 months, obtained through Early Head Start ChildPlus database which records child's binary annual dental visit (yes/no) and other required health screenings
Month 12 visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Francisco

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of California, Los Angeles
National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stuart Gansky, DrPH, University of California, San Francisco
  • Principal Investigator: Francisco Ramos-Gomez, DDS, MS, MPH, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 9, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 13, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 3, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NIDCR 17-084-E UH3DE025514
  • UH3DE025514 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be made available.

IPD Sharing Time Frame

Specifics are undecided but will be in accordance with NIH rules

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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