Clinical trial NCT03576326: BEhavioral EConomics for Oral Health iNnovation Trial
Official title: Influence of Financial Incentives on Oral Disease Management in Young Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Toothbrushing
Dental Plaque
Parent-Child Relations
Oral Hygiene
Dental Caries
Keywords: Preventive Dentistry
Health Disparities
Health Behavior
Behavioral Economics
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2018-07-03
Enrollment: 244
Sex: ALL
Minimum age (years): 6
Maximum age (years): 47
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Toothbrushing performance
timeFrame: Baseline visit through the Month 6 visit
Secondary outcomes:
measure: Short-term (immediate) toothbrushing performance
timeFrame: Baseline visit through the Month 1 visit
measure: Mid-term toothbrushing performance
timeFrame: Baseline visit through the Month 3 visit
measure: Toothbrushing performance sustainability
timeFrame: Month 6 visit through the Month 12 visit
measure: Cost-effectiveness ratio
timeFrame: 1, 2, 5, 10, and 20 years
measure: Cost-effectiveness return on investment
timeFrame: 1, 2, 5, 10, and 20 years
measure: Self-efficacy scale
timeFrame: Baseline visit through Month 6 visit
measure: Modified Simplified Oral Hygiene Index
timeFrame: Month 6 visit and Month 12 visit
measure: Change from Baseline in toothpaste weight
timeFrame: From Baseline to Month 6 visit and From Month 6 visit to Month 12 visit
measure: Untreated caries
timeFrame: Month 6 visit and Month 12 visit
measure: Caries experience
timeFrame: Month 6 visit and Month 12 visit
measure: Severe caries
timeFrame: Month 6 visit and Month 12 visit
measure: Past year dental visit
timeFrame: Month 6 visit and Month 12 visit
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Venice Family Clinic Children First Early Head Start
state: California
Study officials:
affiliation: University of California, San Francisco
name: Stuart Gansky, DrPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Francisco Ramos-Gomez, DDS, MS, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.