Dental Caries, Dental Plaque, Oral Hygiene, Parent-Child Relations, Toothbrushing
Conditions
Keywords
Preventive Dentistry, Health Disparities, Health Behavior, Behavioral Economics, Monetary Incentives
Brief summary
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
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.
Interventions
BEHAVIORALFixed Incentive
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.
BEHAVIORALDrawing Incentive
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.
Sponsors
University of California, Los Angeles
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.)
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
6 Months to 42 Months
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of parents/caregivers attending a dental visit | Month 2 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. |
| Mean number of qualifying half-day toothbrushing episodes per week | Baseline visit through the Month 2 visit | 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.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fluoridated toothpaste use | Baseline visit through the Month 2 visit | Change in child toothpaste pump weight |
| Child plaque score | Month 2 visit | 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). |
| EHS site participation | Month 0 | Willingness of LA County EHS to sign memoranda of understanding |
| EHS staff participation | Month 0 | Willingness of EHS staff participation in assisting with recruitment |
| Proportion of parents/caregivers who consent | Baseline visit | Willingness of parents/caregivers to provide informed consent and approve access to ChildPlus dental visit data |
| Proportion of parents/caregivers willing to be randomized | Baseline visit | Willingness of parents/caregivers to be randomized to a study arm as part of the consenting process |
| Proportion of parents/caregivers adhering to study procedures | Baseline visit through the Month 2 visit | 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 |
| Proportion of children who cooperate | Baseline visit through the Month 2 visit | Willingness of child to cooperate with study procedures, including dental screening, extraoral photo, and plaque assessment |
| Proportion of parents/caregivers willing to use the toothpaste pump | Baseline visit through the Month 2 visit | Willingness to use the toothpaste pump (percentage with any use and percentage change in pump weight) |
| Proportion of weeks the parent/caregiver synced toothbrushing data with the app | Baseline visit through Month 2 visit | Proportion of weeks the parent/caregiver synced toothbrushing data with the app |
| Feasibility of using toothpaste pump weight as a measure of usage | Month 2 visit | Bringing the toothpaste pump to the follow-up visit for weighing |
| Proportion of parents/caregivers willing to use the disclosing solution | Baseline visit and Month 2 visit | Willingness of children to comply with the plaque disclosing procedure |
| Proportion of parents/caregivers willing to use photographs for central assessment | Baseline visit and Month 2 visit | 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 |
| Proportion of parents/caregivers willing to use smart powered toothbrush | Baseline visit through Month 2 visit | Willingness to use the smart powered toothbrush handle (percentage with any brushing data) |
| Comfort with smart powered toothbrush | Baseline visit through Month 2 visit | Child and parent comfort level with using the smart powered toothbrush |
| Proportion of parents/caregivers willing to use smartphone app | Baseline visit | Willingness to download the smartphone app and keep it for the duration of the study |
| Proportion of parents/caregivers willing to receive text messages | Baseline visit | Willingness to be contacted with study-related text messages each week during the intervention period |
| Feasibility of syncing toothbrush to app | Baseline visit | Successfully synced the toothbrush to app during baseline visit |
| Feasibility of measuring toothbrushing frequency with diaries | Month 2 visit | Bringing toothbrushing diaries to the follow-up visit and willingness to provide them to study staff |
| Mean number of days per week with parent/caregiver-reported twice daily brushing | Baseline visit through the Month 2 visit | Twice daily brushing with fluoridated toothpaste, based on parent/caregiver-reported frequency diaries |
Countries
United States
Outcome results
None listed