BEhavioral EConomics for Oral Health iNnovation Trial

NCT03576326 | Completed Results DMC

• 2 other identifiers: NIDCR 17-084-E UH3DE025514UH3DE025514
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Toothbrushing; Dental Plaque; Parent-Child Relations; Oral Hygiene; Dental Caries

Keywords

Preventive Dentistry; Health Disparities; Health Behavior; Behavioral Economics

Outcome Measures

Primary Outcomes (1)

• Toothbrushing Performance

  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 Outcomes (10)

• Short-term (Immediate) Toothbrushing Performance

  Baseline visit through the Month 1 visit

• Mid-term Toothbrushing Performance

  Baseline visit through the Month 3 visit

• Toothbrushing Performance Sustainability

  Month 6 visit through the Month 12 visit

• Self-efficacy Scale

  Month 6 visit

• Modified Simplified Oral Hygiene Index

  Month 6 visit and Month 12 visit

Study Arms (2)

Incentive Drawing

EXPERIMENTAL

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

Control - Delayed Incentive

NO INTERVENTION

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.

Interventions

Drawing Incentive BEHAVIORAL

The Monetary Reward intervention is a drawing reward, in which participants are eligible for weekly rewards based on toothbrushing performance.

Incentive Drawing

Eligibility Criteria

• Age: 6 Months - 47 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of California, Los Angeles: collaborator
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

Venice Family Clinic Children First Early Head Start

Santa Monica, California, 90405-1828, United States

Location

Related Publications (1)

• Ramos-Gomez F, White JS, Lindau HE, Lin TK, Finlayson TL, Liu JX, Gansky SA. Family monetary incentives as a value-based care model for oral hygiene: rationale and design of the BEhavioral EConomics for Oral health iNnovation (BEECON) trial. J Public Health Dent. 2020 Oct 8:10.1111/jphd.12406. doi: 10.1111/jphd.12406. Online ahead of print.

  PMID: 33090505 DERIVED

MeSH Terms

Conditions

Dental Plaque; Dental Caries; Health Behavior

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Tooth Demineralization; Behavior

Results Point of Contact

• Title: Dr. Stuart Gansky
• Organization: University of California, San Francisco

stuart.gansky@ucsf.edu

415-502-8094

Study Officials

• Stuart Gansky, DrPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Francisco Ramos-Gomez, DDS, MS, MPH

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: An independent outcomes assessor and PIs will be blinded to participants' group assignment, and participants will be told that the examiner and PIs cannot answer any incentive questions and they should not mention the incentive program to them. (Due to the nature of the intervention, the staff explaining the study arms after randomization and providing the incentive gift cards at follow-up visits cannot be blinded.)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible consenting parent-child participant dyads, within strata and permuted blocks, will be randomized in equal allocation to one of two arms. Strata will be based on site and smartphone operating system (iOS or Android).

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: July 3, 2018
• Study Start: May 9, 2018
• Primary Completion: May 13, 2021
• Study Completion: June 30, 2021
• Last Updated: September 19, 2025
• Results First Posted: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Specifics are undecided but will be in accordance with NIH rules

Locations

US (1)