Clinical trial NCT03862443: BEhavioral EConomics for Oral Health iNnovation Pilot Trial
Official title: Influence of Financial Incentives on Oral Disease Management in Young Children: A Randomized Pilot Trial
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
Monetary Incentives
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
First posted: 2019-03-05
Enrollment: 36
Sex: ALL
Minimum age (years): 6
Maximum age (years): 42
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 three arms. Strata will be based on smartphone operating system (iOS or Android).
Primary purpose: PREVENTION

Brief summary: This Phase I randomized pilot trial will assess the efficacy of a fixed incentive payment program and drawing incentive payment program versus a control program to promote early childhood caries (ECC) preventive health behaviors (i.e., toothbrushing performance and dental visit attendance) for young children of predominantly Latino parents/caregivers enrolled in/waitlisted for Early Head Start (EHS) home visit programs.

Detailed description: If both groups are acceptable and feasible, the reward group with toothbrushing outcomes at least 20% better than the other one (and the control) will be chosen for a future Phase II/III trial; if they are similar, the fixed monetary reward will be used because it is simpler to explain, monitor, and implement.

Eligibility criteria: Inclusion Criteria for 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 visit.
* Male or female, aged 18 and older.
* Speak, read, and write either English or Spanish.
* Be a parent or caregiver of a child at least 6 months old but less than 3.5 years (42 months), with at least 2 fully erupted teeth and enrolled in, or waitlisted for, one of the three participating Los Angeles County EHS home visit programs.
* Not be planning to move residence for the next 6 months outside the greater Los Angeles area.
* Own a smartphone with the Google Play or iTunes store and be willing to download the smart powered TB app
* Be willing to be contacted via text-messaging (SMS) for study related notifications, such as incentives earned or reminders to sync the TB

Exclusion Criteria:

* Known allergic reaction to components of the study product(s).
* Uncooperative or behaviorally unsuited (assessed during a TB prophylaxis at the initial baseline study visit).
* A sibling of a child already 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.

Primary outcomes:
measure: Mean number of qualifying half-day toothbrushing episodes per week
timeFrame: Baseline visit through the Month 2 visit
measure: Proportion of parents/caregivers attending a dental visit
timeFrame: Month 2 visit
Secondary outcomes:
measure: Proportion of weeks the parent/caregiver synced toothbrushing data with the app
timeFrame: Baseline visit through Month 2 visit
measure: Mean number of days per week with parent/caregiver-reported twice daily brushing
timeFrame: Baseline visit through the Month 2 visit
measure: Fluoridated toothpaste use
timeFrame: Baseline visit through the Month 2 visit
measure: Child plaque score
timeFrame: Month 2 visit
measure: EHS site participation
timeFrame: Month 0
measure: EHS staff participation
timeFrame: Month 0
measure: Proportion of parents/caregivers who consent
timeFrame: Baseline visit
measure: Proportion of parents/caregivers willing to be randomized
timeFrame: Baseline visit
measure: Proportion of parents/caregivers adhering to study procedures
timeFrame: Baseline visit through the Month 2 visit
measure: Proportion of children who cooperate
timeFrame: Baseline visit through the Month 2 visit
measure: Proportion of parents/caregivers willing to use the toothpaste pump
timeFrame: Baseline visit through the Month 2 visit
measure: Feasibility of measuring toothbrushing frequency with diaries
timeFrame: Month 2 visit
measure: Feasibility of using toothpaste pump weight as a measure of usage
timeFrame: Month 2 visit
measure: Proportion of parents/caregivers willing to use the disclosing solution
timeFrame: Baseline visit and Month 2 visit
measure: Proportion of parents/caregivers willing to use photographs for central assessment
timeFrame: Baseline visit and Month 2 visit
measure: Proportion of parents/caregivers willing to use smart powered toothbrush
timeFrame: Baseline visit through Month 2 visit
measure: Comfort with smart powered toothbrush
timeFrame: Baseline visit through Month 2 visit
measure: Proportion of parents/caregivers willing to use smartphone app
timeFrame: Baseline visit
measure: Proportion of parents/caregivers willing to receive text messages
timeFrame: Baseline visit
measure: Feasibility of syncing toothbrush to app
timeFrame: Baseline 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 A Gansky, DrPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Francisco Ramos-Gomez, DDS, MS, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: James G Kahn, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: White JS, Ramos-Gomez F, Liu JX, Jue B, Finlayson TL, Garza JR, Crawford AH, Helman S, Santo W, Cheng J, Kahn JG, Gansky SA. Monetary incentives for improving smartphone-measured oral hygiene behaviors in young children: A randomized pilot trial. PLoS One. 2020 Jul 30;15(7):e0236692. doi: 10.1371/journal.pone.0236692. eCollection 2020.