Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UH3DE025514 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of California, Los Angeles | OTHER |
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Incentive Drawing | Experimental | 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). |
|
| Control - Delayed Incentive | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drawing Incentive | Behavioral | The Monetary Reward intervention is a drawing reward, in which participants are eligible for weekly rewards based on toothbrushing performance. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Toothbrushing Performance | Mean of the 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 6 visit |
| Measure | Description | Time Frame |
|---|---|---|
| Short-term (Immediate) Toothbrushing Performance | Mean number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth. | Baseline visit through the Month 1 visit |
| Mid-term Toothbrushing Performance |
Not provided
Inclusion Criteria:
Child
Parent/caregiver
Stakeholder
Exclusion Criteria:
Child
Parent/caregiver
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stuart Gansky, DrPH | University of California, San Francisco | Principal Investigator |
| Francisco Ramos-Gomez, DDS, MS, MPH | University of California, Los Angeles | 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 |
|---|---|---|---|
| 33090505 | Derived | Ramos-Gomez F, White JS, Lindau HE, Lin TK, Finlayson TL, Liu JX, Gansky SA. Family monetary incentives as a value-based care model for oral hygiene: rationale and design of the BEhavioral EConomics for Oral health iNnovation (BEECON) trial. J Public Health Dent. 2020 Oct 8:10.1111/jphd.12406. doi: 10.1111/jphd.12406. Online ahead of print. |
Not provided
Not provided
De-identified data will be made available.
Specifics are undecided but will be in accordance with NIH rules
Not provided
Child-Parent Dyads were recruited and Dyad is the unit of analysis Protocol Enrollment number is the number of Dyads recruited, enrolled, and analyzed; total number of participants who Started the study is the number of Individual participants in the study (i.e., 2x number of dyads).
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Incentive Drawing: Children | 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). Drawing Incentive: The Monetary Reward intervention is a drawing reward, in which participants are eligible for weekly rewards based on toothbrushing performance. |
| FG001 | Incentive Drawing: Parents | 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). Drawing Incentive: The Monetary Reward intervention is a drawing reward, in which participants are eligible for weekly rewards based on toothbrushing performance. |
| FG002 | Control - Delayed Incentive: Children | 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. |
| FG003 | Control - Delayed Incentive: Parents | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Child-Caregiver (Parent) Dyads
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Incentive Drawing: Children | 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). Drawing Incentive: The Monetary Reward intervention is a drawing reward, in which participants are eligible for weekly rewards based on toothbrushing performance. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Toothbrushing Performance | Mean of the 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.) | any post-baseline evaluable data from 0 to 6 months | Posted | Mean | Standard Deviation | qualifying half-day episodes per week | Baseline visit through the Month 6 visit |
|
2 years
Adverse events were observed for child participants only; parents were not monitored/assessed any of their own adverse events
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Incentive Drawing: Children | 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). Drawing Incentive: The Monetary Reward intervention is a drawing reward, in which participants are eligible for weekly rewards based on toothbrushing performance. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tooth fracture | Injury, poisoning and procedural complications | Systematic Assessment | Fractured/broken tooth due to accident such as falling |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stuart Gansky | University of California, San Francisco | 415-502-8094 | stuart.gansky@ucsf.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 19, 2020 | Mar 12, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: English | Aug 15, 2018 | Mar 12, 2025 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Spanish | Aug 15, 2018 | Mar 12, 2025 | ICF_002.pdf |
Not provided
| 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 |
Not provided
Not provided
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).
Not provided
Not provided
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.)
Mean number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth.
| Baseline visit through the Month 3 visit |
| Toothbrushing Performance Sustainability | Mean number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth. | Month 6 visit through the Month 12 visit |
| Self-efficacy Scale | Caregiver (parent) oral health self-efficacy items (total score ranges 6-30 with higher score indicating more self-efficacy; 6 items each on 1-5 ordinal scale, Albino et al.; Finlayson et al.) | Month 6 visit |
| Modified Simplified Oral Hygiene Index | Debris Index of the Simplified Oral Hygiene Index for Maxillary Incisors (OHI-MIS) to measure child's plaque on primary maxillary incisor facial (labial) tooth surfaces (mean of 4 ordinal scores each with values ranging from no plaque (1) - which is best - to abundant plaque (4) - which is worst) | Month 6 visit and Month 12 visit |
| Change From Baseline in Toothpaste Weight | Change in child's toothpaste pump weight (grams) from each distribution visit (6 months prior). Negative mean values are a decrease from an earlier time to a subsequent time. | From Baseline to Month 6 visit and From Month 6 visit to Month 12 visit |
| Untreated Caries | Number and percent of children with untreated caries using Association of State and Territorial Dental Directors Basic Screening Survey (ASTDD BSS) binary (yes/no) measure of child's untreated caries status (dt>0) | Month 6 visit and Month 12 visit |
| Caries Experience | Number and percent of children with any history of caries using Association of State and Territorial Dental Directors Basic Screening Survey (ASTDD BSS) binary (yes/no) measure of child's caries experience status (dmft>0) | Month 6 visit and Month 12 visit |
| Severe Caries | Number and percent of children with severe caries experience using Association of State and Territorial Dental Directors Basic Screening Survey (ASTDD BSS) binary (yes/no) measure of child's severe caries experience status (dmft>=4) | Month 6 visit and Month 12 visit |
| Past Year Dental Visit | Number and percent of children with a dental visit in the past 12 months, obtained through Early Head Start ChildPlus database which records child's binary annual dental visit (yes/no) and other required health screenings | Month 12 visit |
| BG001 | Incentive Drawing: Parents | 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). Drawing Incentive: The Monetary Reward intervention is a drawing reward, in which participants are eligible for weekly rewards based on toothbrushing performance. |
| BG002 | Control - Delayed Incentive: Children | 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. |
| BG003 | Control - Delayed Incentive: Parents | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Study Site | Count of Participants | Participants |
|
| OG001 | Incentive Drawing: Parents | 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). Drawing Incentive: The Monetary Reward intervention is a drawing reward, in which participants are eligible for weekly rewards based on toothbrushing performance. |
|
|
| Secondary | Short-term (Immediate) Toothbrushing Performance | Mean number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth. | any post-baseline evaluable data from 0 to 1 months | Posted | Mean | Standard Deviation | qualifying half-day episodes per week | Baseline visit through the Month 1 visit |
|
|
|
| Secondary | Mid-term Toothbrushing Performance | Mean number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth. | any post-baseline evaluable data from 0 to 3 months | Posted | Mean | Standard Deviation | qualifying half-day episodes per week | Baseline visit through the Month 3 visit |
|
|
|
| Secondary | Toothbrushing Performance Sustainability | Mean number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth. | any post-baseline evaluable data from 6 to 12 months | Posted | Mean | Standard Deviation | qualifying half-day episodes per week | Month 6 visit through the Month 12 visit |
|
|
|
| Secondary | Self-efficacy Scale | Caregiver (parent) oral health self-efficacy items (total score ranges 6-30 with higher score indicating more self-efficacy; 6 items each on 1-5 ordinal scale, Albino et al.; Finlayson et al.) | some participants did not complete the self-efficacy instrument at 6 months | Posted | Mean | Standard Deviation | score on a scale | Month 6 visit |
|
|
|
| Secondary | Modified Simplified Oral Hygiene Index | Debris Index of the Simplified Oral Hygiene Index for Maxillary Incisors (OHI-MIS) to measure child's plaque on primary maxillary incisor facial (labial) tooth surfaces (mean of 4 ordinal scores each with values ranging from no plaque (1) - which is best - to abundant plaque (4) - which is worst) | Not all randomized children were available for evaluation at Month 6 and Month 12. | Posted | Mean | Standard Deviation | units on a scale | Month 6 visit and Month 12 visit |
|
|
|
| Secondary | Change From Baseline in Toothpaste Weight | Change in child's toothpaste pump weight (grams) from each distribution visit (6 months prior). Negative mean values are a decrease from an earlier time to a subsequent time. | Data were only available for participants who brought toothpaste tube back on follow-up visits at Month 6 and Month 12. | Posted | Mean | Standard Deviation | grams | From Baseline to Month 6 visit and From Month 6 visit to Month 12 visit |
|
|
|
| Secondary | Untreated Caries | Number and percent of children with untreated caries using Association of State and Territorial Dental Directors Basic Screening Survey (ASTDD BSS) binary (yes/no) measure of child's untreated caries status (dt>0) | Not all randomized children were available for evaluation at Month 6 and Month 12. | Posted | Count of Participants | Participants | Month 6 visit and Month 12 visit |
|
|
|
| Secondary | Caries Experience | Number and percent of children with any history of caries using Association of State and Territorial Dental Directors Basic Screening Survey (ASTDD BSS) binary (yes/no) measure of child's caries experience status (dmft>0) | Not all randomized children were available for evaluation at Month 6 and Month 12. | Posted | Count of Participants | Participants | Month 6 visit and Month 12 visit |
|
|
|
| Secondary | Severe Caries | Number and percent of children with severe caries experience using Association of State and Territorial Dental Directors Basic Screening Survey (ASTDD BSS) binary (yes/no) measure of child's severe caries experience status (dmft>=4) | Not all randomized children were available for evaluation at Month 6 and Month 12. | Posted | Count of Participants | Participants | Month 6 visit and Month 12 visit |
|
|
|
| Secondary | Past Year Dental Visit | Number and percent of children with a dental visit in the past 12 months, obtained through Early Head Start ChildPlus database which records child's binary annual dental visit (yes/no) and other required health screenings | Data was not systematically recorded in the Early Head Start (EHS) ChildPlus database for individual child participants. EHS reports total number of visits per month but does not record that info for individuals in the EHS ChildPlus database. | Posted | Count of Participants | Participants | Month 12 visit |
|
|
|
| 0 |
| 122 |
| 0 |
| 122 |
| 3 |
| 122 |
| EG001 | Incentive Drawing: Parents | 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). Drawing Incentive: The Monetary Reward intervention is a drawing reward, in which participants are eligible for weekly rewards based on toothbrushing performance. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Control - Delayed Incentive: Children | 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. | 0 | 122 | 0 | 122 | 5 | 122 |
| EG003 | Control - Delayed Incentive: Parents | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
|
| Dental infection/abscess | Infections and infestations | Non-systematic Assessment |
|
| Dental crown | General disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D001519 |
| Behavior |
| Month 12 |
|
|
| Month 6 to Month 12 |
|
|
| Month 12 |
|
|
| Month 12 |
|
|
| Month 12 |
|
|