- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03576326
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
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
244
Phase
- 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
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California
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Santa Monica, California, United States, 90405-1828
- Venice Family Clinic Children First Early Head Start
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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
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 |
Intervention / Treatment |
|---|---|
|
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).
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The Monetary Reward intervention is a drawing reward, in which participants are eligible for weekly rewards based on toothbrushing performance.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Toothbrushing Performance
Time Frame: Baseline visit through the Month 6 visit
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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.)
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Baseline visit through the Month 6 visit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Short-term (Immediate) Toothbrushing Performance
Time Frame: Baseline visit through the Month 1 visit
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Mean number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth.
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Baseline visit through the Month 1 visit
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Mid-term Toothbrushing Performance
Time Frame: Baseline visit through the Month 3 visit
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Mean number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth.
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Baseline visit through the Month 3 visit
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Toothbrushing Performance Sustainability
Time Frame: Month 6 visit through the Month 12 visit
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Mean number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth.
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Month 6 visit through the Month 12 visit
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Self-efficacy Scale
Time Frame: Month 6 visit
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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.)
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Month 6 visit
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Modified Simplified Oral Hygiene Index
Time Frame: Month 6 visit and Month 12 visit
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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)
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Month 6 visit and Month 12 visit
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Change From Baseline in Toothpaste Weight
Time Frame: From Baseline to Month 6 visit and From Month 6 visit to Month 12 visit
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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.
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From Baseline to Month 6 visit and From Month 6 visit to Month 12 visit
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Untreated Caries
Time Frame: Month 6 visit and Month 12 visit
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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)
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Month 6 visit and Month 12 visit
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Caries Experience
Time Frame: Month 6 visit and Month 12 visit
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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)
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Month 6 visit and Month 12 visit
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Severe Caries
Time Frame: Month 6 visit and Month 12 visit
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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)
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Month 6 visit and Month 12 visit
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Past Year Dental Visit
Time Frame: Month 12 visit
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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
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Month 12 visit
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- 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.
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)
May 9, 2018
Primary Completion (Actual)
May 13, 2021
Study Completion (Actual)
June 30, 2021
Study Registration Dates
First Submitted
May 23, 2018
First Submitted That Met QC Criteria
June 21, 2018
First Posted (Actual)
July 3, 2018
Study Record Updates
Last Update Posted (Estimated)
September 19, 2025
Last Update Submitted That Met QC Criteria
September 17, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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