BEhavioral EConomics for Oral Health iNnovation Trial

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

244 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-09

Study Completion Date

2021-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Toothbrushing Dental Plaque Parent-Child Relations Oral Hygiene Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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.)

Study Groups

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Incentive Drawing

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).

Group Type EXPERIMENTAL

Drawing Incentive

Intervention Type BEHAVIORAL

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

Control - Delayed Incentive

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Drawing Incentive

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

6 Months

Maximum Eligible Age

47 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes