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BEhavioral EConomics for Oral Health iNnovation Pilot Trial

Not Applicable
Completed
Conditions
Parent-Child Relations
Oral Hygiene
Toothbrushing
Dental Plaque
Dental Caries
Interventions
Behavioral: Drawing Incentive
Behavioral: 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
Inclusion Criteria

Not provided

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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Drawing IncentiveDrawing IncentiveEligible 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 IncentiveFixed IncentiveEligible 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
NameTimeMethod
Mean number of qualifying half-day toothbrushing episodes per weekBaseline 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 visitMonth 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
NameTimeMethod
Proportion of weeks the parent/caregiver synced toothbrushing data with the appBaseline visit through Month 2 visit

Proportion of weeks the parent/caregiver synced toothbrushing data with the app

Fluoridated toothpaste useBaseline visit through the Month 2 visit

Change in child toothpaste pump weight

Mean number of days per week with parent/caregiver-reported twice daily brushingBaseline visit through the Month 2 visit

Twice daily brushing with fluoridated toothpaste, based on parent/caregiver-reported frequency diaries

Proportion of parents/caregivers who consentBaseline visit

Willingness of parents/caregivers to provide informed consent and approve access to ChildPlus dental visit data

Proportion of parents/caregivers adhering to study proceduresBaseline 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 pumpBaseline 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 appBaseline visit

Successfully synced the toothbrush to app during baseline visit

Proportion of parents/caregivers willing to be randomizedBaseline 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 assessmentBaseline 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 toothbrushBaseline visit through Month 2 visit

Child and parent comfort level with using the smart powered toothbrush

EHS site participationMonth 0

Willingness of LA County EHS to sign memoranda of understanding

EHS staff participationMonth 0

Willingness of EHS staff participation in assisting with recruitment

Feasibility of measuring toothbrushing frequency with diariesMonth 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 usageMonth 2 visit

Bringing the toothpaste pump to the follow-up visit for weighing

Proportion of parents/caregivers willing to use the disclosing solutionBaseline visit and Month 2 visit

Willingness of children to comply with the plaque disclosing procedure

Proportion of parents/caregivers willing to use smart powered toothbrushBaseline 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 appBaseline visit

Willingness to download the smartphone app and keep it for the duration of the study

Child plaque scoreMonth 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 cooperateBaseline 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 messagesBaseline 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

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