BEhavioral EConomics for Oral Health iNnovation Pilot Trial (BEECON Pilot)

University of California San Francisco (UCSF)

Status: Completed

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

Treatments: Behavioral: Drawing Incentive; Behavioral: Fixed Incentive

Study type: Interventional

Funder types: Other

Identifiers

NCT03862443

16-19968

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 6 to 42 months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 3 patient groups

Fixed Incentive

Experimental group

Description:

Eligible to earn a weekly payment during the 2-month incentive intervention period. Possible weekly winnings depend on toothbrushing performance collected through smart powered toothbrush synced to a smartphone app: low adherence threshold (brushing child's teeth once per day for 7 days in a week) will win $5; high adherence threshold (brushing twice per day for 14 days in a week) will win $10.

Treatment:

Behavioral: Fixed Incentive

Drawing Incentive

Experimental group

Description:

Eligible to earn a weekly drawing entry with different winning probabilities during the 2-month incentive intervention period. Possible weekly winnings depend on toothbrushing performance collected through smart powered toothbrush synced to a smartphone app: 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 2-months, but information on toothbrushing performance collected through smart powered toothbrush synced to a smartphone app. After the Month 2 follow-up visit, may opt to participate in a delayed 2-month open label extension to earn the same monetary rewards the fixed incentive intervention group could earn Baseline through Month 2. 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.