BEhavioral EConomics for Oral Health iNnovation Trial

Not Applicable

Completed

• Conditions: Dental Plaque; Parent-Child Relations; Toothbrushing; Oral Hygiene; Dental Caries
• Interventions: Behavioral: Drawing Incentive

• Registration Number: NCT03576326
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-09
• Study First Submitted: 2018-05-23
• Study First Submitted QC: 2018-06-21
• Study First Posted: 2018-07-03
• Primary Completion: 2021-05-13
• Study Completion: 2021-06-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-23
• Last Update Posted: 2021-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 244

Inclusion Criteria

• Child

  • at least 2 fully erupted teeth
  • enrolled in, or waitlisted for, one of the participating Los Angeles County Early Head Start (EHS) or affiliated day care center or area clinic programs

• 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
  • aged 18 or older
  • speak either English or Spanish and self-reported ability to read and write either English or Spanish
  • be a parent or caregiver of a child at least 6 months old but less than 4 years (48 months), with at least 2 fully erupted teeth and enrolled in, or waitlisted for, one of the participating Los Angeles County EHS or affiliated day care center or area clinic programs
  • not be planning to move residence for the next 18 months outside the greater Los Angeles area
  • own a smartphone with Google Play or iTunes store app and be willing to download and install the smart powered toothbrush app at the Screening visit and keep it installed for the duration of the project. [If the app cannot be properly installed by the baseline visit, the participant will not be randomized.]
  • be willing to be contacted via text-messaging (SMS) for study related notifications, such as incentives earned or reminders to sync the toothbrush

• Stakeholder

  • be a staff member at a participating study site (e.g. EHS or affiliated day care center)
  • verbally agree to participate after being provided a study information sheet

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Exclusion Criteria

• Child

  • known allergic reaction to components of the study product(s)
  • uncooperative or behaviorally unsuited (assessed during a toothbrush prophylaxis, ASTDD Basic Screening Survey caries screening, and photograph of maxillary incisors at the screening visit)
  • more than 2 crowns on maxillary incisor teeth (teeth# D, E, F, G, or equivalently #52, 51, 61, 62).
  • participated in the BEECON pilot trial
  • a sibling of a child 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

• Parent/caregiver

  • participated in the BEECON pilot trial
  • unable or unwilling to install and use the smart powered toothbrush app during the run-in period

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Incentive Drawing	Drawing Incentive	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).

Primary Outcome Measures

Name	Time	Method
Toothbrushing performance	Baseline visit through the Month 6 visit	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.)

Secondary Outcome Measures

Name	Time	Method
Self-efficacy scale	Baseline visit through Month 6 visit	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.)
Change from Baseline in toothpaste weight	From Baseline to Month 6 visit and From Month 6 visit to Month 12 visit	Change in toothpaste pump weight (grams) from each distribution visit (6 months prior)
Caries experience	Month 6 visit and Month 12 visit	Binary measure of Association of State and Territorial Dental Directors Basic Screening Survey (ASTDD BSS) caries experience status (dmft\>0)
Severe caries	Month 6 visit and Month 12 visit	Binary measure of Association of State and Territorial Dental Directors Basic Screening Survey (ASTDD BSS) severe caries experience status (dmft\>=4)
Mid-term toothbrushing performance	Baseline visit through the Month 3 visit	Mean number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth.
Modified Simplified Oral Hygiene Index	Month 6 visit and Month 12 visit	Debris Index of the Simplified Oral Hygiene Index for Maxillary Incisors (OHI-MIS) to measure plaque on primary maxillary incisor facial (labial) tooth surfaces (mean of 4 ordinal scores)
Past year dental visit	Month 6 visit and Month 12 visit	Binary measure of a dental visit in the past 12 months, obtained through Early Head Start ChildPlus database which records annual dental visit and other required health screenings
Short-term (immediate) toothbrushing performance	Baseline visit through the Month 1 visit	Mean number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth.
Toothbrushing performance sustainability	Month 6 visit through the Month 12 visit	Mean number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth.
Cost-effectiveness return on investment	1, 2, 5, 10, and 20 years	Short- and long-term return on investment (ROI) comparing intervention program costs versus future treatment costs averted
Cost-effectiveness ratio	1, 2, 5, 10, and 20 years	Short- and long-term incremental cost effectiveness ratios (ICERs) improving parent/caregiver toothbrushing performance relative to cost
Untreated caries	Month 6 visit and Month 12 visit	Binary measure of Association of State and Territorial Dental Directors Basic Screening Survey (ASTDD BSS) untreated caries status (dt\>0)

Trial Locations

Locations (1)

Venice Family Clinic Children First Early Head Start; 🇺🇸 Santa Monica, California, United States