BEhavioral EConomics for Oral Health iNnovation Trial

Dental Caries Clinical Trial

— BEECON  

Official title:

Influence of Financial Incentives on Oral Disease Management in Young Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03576326
• Other study ID #: NIDCR 17-084-E UH3DE025514
• Secondary ID: UH3DE025514
• Status: Completed
• Phase: N/A
• Start date: May 9, 2018
• Est. completion date: June 30, 2021

Study information

• Verified date: September 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: June 30, 2021
• Est. primary completion date: May 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 47 Months

Eligibility

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

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

Related Conditions & MeSH terms

• Dental Caries
• Dental Plaque
• Oral Hygiene
• Parent-Child Relations
• Toothbrushing

Intervention

Behavioral:
• Drawing Incentive
The Monetary Reward intervention is a drawing reward, in which participants are eligible for weekly rewards based on toothbrushing performance.

Locations

Country	Name	City	State
United States	Venice Family Clinic Children First Early Head Start	Santa Monica	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute of Dental and Craniofacial Research (NIDCR), University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.)	Baseline visit through the Month 6 visit
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.	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.	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.	Month 6 visit through the Month 12 visit
Secondary	Cost-effectiveness ratio	Short- and long-term incremental cost effectiveness ratios (ICERs) improving parent/caregiver toothbrushing performance relative to cost	1, 2, 5, 10, and 20 years
Secondary	Cost-effectiveness return on investment	Short- and long-term return on investment (ROI) comparing intervention program costs versus future treatment costs averted	1, 2, 5, 10, and 20 years
Secondary	Self-efficacy scale	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.)	Baseline visit through Month 6 visit
Secondary	Modified Simplified Oral Hygiene Index	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)	Month 6 visit and Month 12 visit
Secondary	Change from Baseline in toothpaste weight	Change in toothpaste pump weight (grams) from each distribution visit (6 months prior)	From Baseline to Month 6 visit and From Month 6 visit to Month 12 visit
Secondary	Untreated caries	Binary measure of Association of State and Territorial Dental Directors Basic Screening Survey (ASTDD BSS) untreated caries status (dt>0)	Month 6 visit and Month 12 visit
Secondary	Caries experience	Binary measure of Association of State and Territorial Dental Directors Basic Screening Survey (ASTDD BSS) caries experience status (dmft>0)	Month 6 visit and Month 12 visit
Secondary	Severe caries	Binary measure of Association of State and Territorial Dental Directors Basic Screening Survey (ASTDD BSS) severe caries experience status (dmft>=4)	Month 6 visit and Month 12 visit
Secondary	Past year dental 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	Month 6 visit and Month 12 visit