BEhavioral EConomics for Oral Health iNnovation Pilot Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Influence of Financial Incentives on Oral Disease Management in Young Children: A Randomized Pilot Trial

Conditions
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Toothbrushing, Dental Plaque, Parent-Child Relations, Oral Hygiene, Dental Caries

Intervention / Treatment
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* Behavioral: Fixed Incentive
* Behavioral: Drawing Incentive


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 42 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fixed Incentive<br>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. | Behavioral: Fixed Incentive<br>* The Fixed Incentive intervention is a fixed reward, in which participants are eligible for fixed weekly payments based on toothbrushing performance collected through smart powered toothbrush synced to a smartphone app.<br>|
| Experimental: Drawing Incentive<br>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). | Behavioral: Drawing Incentive<br>* The Drawing Incentive intervention is a drawing reward, in which participants are eligible for weekly payments based on toothbrushing performance collected through smart powered toothbrush synced to a smartphone app.<br>|
| No Intervention: Control - Delayed Incentive<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean number of qualifying half-day toothbrushing episodes per week | Mean number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth. (A Bluetooth-recorded toothbrushing episode qualifies if it lasts at least one minute within one of 14 half-day windows in the week.) | Baseline visit through the Month 2 visit | 
| Proportion of parents/caregivers attending a dental visit | In the subset of children at baseline with no dental visit in the EHS ChildPlus health module, whether or not the child has a ChildPlus documented dental visit at the two-month follow-up. | Month 2 visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of weeks the parent/caregiver synced toothbrushing data with the app | Proportion of weeks the parent/caregiver synced toothbrushing data with the app | Baseline visit through Month 2 visit | 
| Mean number of days per week with parent/caregiver-reported twice daily brushing | Twice daily brushing with fluoridated toothpaste, based on parent/caregiver-reported frequency diaries | Baseline visit through the Month 2 visit | 
| Fluoridated toothpaste use | Change in child toothpaste pump weight | Baseline visit through the Month 2 visit | 
| Child plaque score | The child's Debris Index component (plaque score) of the Simplified Oral Hygiene Index (Greene and Vermillion) modified to include only maxillary incisor teeth after disclosing with plaque solution. The scale (which is a mean value) range is 0 (no debris or stain) to 3 (soft debris covering more than two thirds of the exposed tooth surface). | Month 2 visit | 
| EHS site participation | Willingness of LA County EHS to sign memoranda of understanding | Month 0 | 
| EHS staff participation | Willingness of EHS staff participation in assisting with recruitment | Month 0 | 
| Proportion of parents/caregivers who consent | Willingness of parents/caregivers to provide informed consent and approve access to ChildPlus dental visit data | Baseline visit | 
| Proportion of parents/caregivers willing to be randomized | Willingness of parents/caregivers to be randomized to a study arm as part of the consenting process | Baseline visit | 
| Proportion of parents/caregivers adhering to study procedures | Willingness of parents/caregivers to adhere to study procedures, including completing questionnaire instruments, bringing toothbrushing frequency diaries to 2-month follow-up visit, and bringing toothpaste pump to 2-month follow-up visit | Baseline visit through the Month 2 visit | 
| Proportion of children who cooperate | Willingness of child to cooperate with study procedures, including dental screening, extraoral photo, and plaque assessment | Baseline visit through the Month 2 visit | 
| Proportion of parents/caregivers willing to use the toothpaste pump | Willingness to use the toothpaste pump (percentage with any use and percentage change in pump weight) | Baseline visit through the Month 2 visit | 
| Feasibility of measuring toothbrushing frequency with diaries | Bringing toothbrushing diaries to the follow-up visit and willingness to provide them to study staff | Month 2 visit | 
| Feasibility of using toothpaste pump weight as a measure of usage | Bringing the toothpaste pump to the follow-up visit for weighing | Month 2 visit | 
| Proportion of parents/caregivers willing to use the disclosing solution | Willingness of children to comply with the plaque disclosing procedure | Baseline visit and Month 2 visit | 
| Proportion of parents/caregivers willing to use photographs for central assessment | Willingness of the child to allow photographs, the ability to transmit the photographs securely, and the ability of the central clinician to score them reliably and confidently | Baseline visit and Month 2 visit | 
| Proportion of parents/caregivers willing to use smart powered toothbrush | Willingness to use the smart powered toothbrush handle (percentage with any brushing data) | Baseline visit through Month 2 visit | 
| Comfort with smart powered toothbrush | Child and parent comfort level with using the smart powered toothbrush | Baseline visit through Month 2 visit | 
| Proportion of parents/caregivers willing to use smartphone app | Willingness to download the smartphone app and keep it for the duration of the study | Baseline visit | 
| Proportion of parents/caregivers willing to receive text messages | Willingness to be contacted with study-related text messages each week during the intervention period | Baseline visit | 
| Feasibility of syncing toothbrush to app | Successfully synced the toothbrush to app during baseline visit | Baseline visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preventive Dentistry, Health Disparities, Health Behavior, Behavioral Economics, Monetary Incentives