BEhavioral EConomics for Oral Health iNnovation Trial (BEECON)

University of California San Francisco (UCSF)

Status: Completed

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

Treatments: Behavioral: Drawing Incentive

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03576326

UH3DE025514 (U.S. NIH Grant/Contract)

NIDCR 17-084-E UH3DE025514

Details and patient eligibility

About

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.

Enrollment: 244 patients

Sex: All

Ages: 6 to 47 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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244 participants in 2 patient groups

Incentive Drawing

Experimental group

Description:

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).

Treatment:

Behavioral: Drawing Incentive

Control - Delayed Incentive

No Intervention group

Description:

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.