BEhavioral EConomics for Oral Health iNnovation Pilot Trial
- Conditions
- Parent-Child RelationsOral HygieneToothbrushingDental PlaqueDental Caries
- Interventions
- Behavioral: Drawing IncentiveBehavioral: Fixed Incentive
- Registration Number
- NCT03862443
- Lead Sponsor
- University of California, San Francisco
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Not provided
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Drawing Incentive Drawing Incentive 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). Fixed Incentive Fixed Incentive 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.
- Primary Outcome Measures
Name Time Method 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.)
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.
- Secondary Outcome Measures
Name Time Method 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
Fluoridated toothpaste use Baseline visit through the Month 2 visit Change in child toothpaste pump weight
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
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 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 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)
Feasibility of syncing toothbrush to app Baseline visit Successfully synced the toothbrush to app during baseline visit
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 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
Comfort with smart powered toothbrush Baseline visit through Month 2 visit Child and parent comfort level with using the smart powered toothbrush
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
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
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 smart powered toothbrush Baseline visit through Month 2 visit Willingness to use the smart powered toothbrush handle (percentage with any brushing data)
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
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).
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 receive text messages Baseline visit Willingness to be contacted with study-related text messages each week during the intervention period
Trial Locations
- Locations (1)
Venice Family Clinic Children First Early Head Start
🇺🇸Santa Monica, California, United States