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| Name | Class |
|---|---|
| University of California, Los Angeles | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed Incentive | Experimental | 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. |
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| Drawing Incentive | Experimental | 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). |
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| Control - Delayed Incentive | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fixed Incentive | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria for Parent/Caregiver:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart A Gansky, DrPH | University of California, San Francisco | Principal Investigator |
| Francisco Ramos-Gomez, DDS, MS, MPH | University of California, Los Angeles | Principal Investigator |
| James G Kahn, MD, MPH | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Venice Family Clinic Children First Early Head Start | Santa Monica | California | 90405-1828 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32730310 | Derived | 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. |
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| ID | Term |
|---|---|
| D003773 | Dental Plaque |
| D003731 | Dental Caries |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D017001 | Tooth Demineralization |
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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).
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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.)
| Drawing Incentive | Behavioral | 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. |
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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 |
| D001519 |
| Behavior |