search
Back to results

BEhavioral EConomics for Oral Health iNnovation Trial (BEECON)

Primary Purpose

Toothbrushing, Dental Plaque, Parent-Child Relations

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Drawing Incentive
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Toothbrushing focused on measuring Preventive Dentistry, Health Disparities, Health Behavior, Behavioral Economics

Eligibility Criteria

6 Months - 47 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Venice Family Clinic Children First Early Head Start

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Incentive Drawing

Control - Delayed Incentive

Arm Description

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).

No rewards during the first 12 months, but information on toothbrushing performance. After the Month 12 follow-up visit, may opt to participate in a delayed 6-month open label extension to earn the same monetary rewards the intervention group could earn Baseline through Month 6. Not a formal part of this trial, but rather a necessary condition to assure all participating parents/caregivers have the chance to earn the same monetary incentives.

Outcomes

Primary Outcome Measures

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.)

Secondary Outcome Measures

Short-term (immediate) toothbrushing performance
Mean number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth.
Mid-term toothbrushing performance
Mean number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth.
Toothbrushing performance sustainability
Mean number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth.
Cost-effectiveness ratio
Short- and long-term incremental cost effectiveness ratios (ICERs) improving parent/caregiver toothbrushing performance relative to cost
Cost-effectiveness return on investment
Short- and long-term return on investment (ROI) comparing intervention program costs versus future treatment costs averted
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.)
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)
Change from Baseline in toothpaste weight
Change in toothpaste pump weight (grams) from each distribution visit (6 months prior)
Untreated caries
Binary measure of Association of State and Territorial Dental Directors Basic Screening Survey (ASTDD BSS) untreated caries status (dt>0)
Caries experience
Binary measure of Association of State and Territorial Dental Directors Basic Screening Survey (ASTDD BSS) caries experience status (dmft>0)
Severe caries
Binary measure of Association of State and Territorial Dental Directors Basic Screening Survey (ASTDD BSS) severe caries experience status (dmft>=4)
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

Full Information

First Posted
May 23, 2018
Last Updated
September 23, 2021
Sponsor
University of California, San Francisco
Collaborators
University of California, Los Angeles, National Institute of Dental and Craniofacial Research (NIDCR)
search

1. Study Identification

Unique Protocol Identification Number
NCT03576326
Brief Title
BEhavioral EConomics for Oral Health iNnovation Trial
Acronym
BEECON
Official Title
Influence of Financial Incentives on Oral Disease Management in Young Children
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 9, 2018 (Actual)
Primary Completion Date
May 13, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
University of California, Los Angeles, National Institute of Dental and Craniofacial Research (NIDCR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Toothbrushing, Dental Plaque, Parent-Child Relations, Oral Hygiene, Dental Caries
Keywords
Preventive Dentistry, Health Disparities, Health Behavior, Behavioral Economics

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Eligible consenting parent-child participant dyads, within strata and permuted blocks, will be randomized in equal allocation to one of two arms. Strata will be based on site and smartphone operating system (iOS or Android).
Masking
InvestigatorOutcomes 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.)
Allocation
Randomized
Enrollment
244 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Incentive Drawing
Arm Type
Experimental
Arm Description
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).
Arm Title
Control - Delayed Incentive
Arm Type
No Intervention
Arm Description
No rewards during the first 12 months, but information on toothbrushing performance. After the Month 12 follow-up visit, may opt to participate in a delayed 6-month open label extension to earn the same monetary rewards the intervention group could earn Baseline through Month 6. Not a formal part of this trial, but rather a necessary condition to assure all participating parents/caregivers have the chance to earn the same monetary incentives.
Intervention Type
Behavioral
Intervention Name(s)
Drawing Incentive
Intervention Description
The Monetary Reward intervention is a drawing reward, in which participants are eligible for weekly rewards based on toothbrushing performance.
Primary Outcome Measure Information:
Title
Toothbrushing performance
Description
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.)
Time Frame
Baseline visit through the Month 6 visit
Secondary Outcome Measure Information:
Title
Short-term (immediate) toothbrushing performance
Description
Mean number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth.
Time Frame
Baseline visit through the Month 1 visit
Title
Mid-term toothbrushing performance
Description
Mean number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth.
Time Frame
Baseline visit through the Month 3 visit
Title
Toothbrushing performance sustainability
Description
Mean number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth.
Time Frame
Month 6 visit through the Month 12 visit
Title
Cost-effectiveness ratio
Description
Short- and long-term incremental cost effectiveness ratios (ICERs) improving parent/caregiver toothbrushing performance relative to cost
Time Frame
1, 2, 5, 10, and 20 years
Title
Cost-effectiveness return on investment
Description
Short- and long-term return on investment (ROI) comparing intervention program costs versus future treatment costs averted
Time Frame
1, 2, 5, 10, and 20 years
Title
Self-efficacy scale
Description
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.)
Time Frame
Baseline visit through Month 6 visit
Title
Modified Simplified Oral Hygiene Index
Description
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)
Time Frame
Month 6 visit and Month 12 visit
Title
Change from Baseline in toothpaste weight
Description
Change in toothpaste pump weight (grams) from each distribution visit (6 months prior)
Time Frame
From Baseline to Month 6 visit and From Month 6 visit to Month 12 visit
Title
Untreated caries
Description
Binary measure of Association of State and Territorial Dental Directors Basic Screening Survey (ASTDD BSS) untreated caries status (dt>0)
Time Frame
Month 6 visit and Month 12 visit
Title
Caries experience
Description
Binary measure of Association of State and Territorial Dental Directors Basic Screening Survey (ASTDD BSS) caries experience status (dmft>0)
Time Frame
Month 6 visit and Month 12 visit
Title
Severe caries
Description
Binary measure of Association of State and Territorial Dental Directors Basic Screening Survey (ASTDD BSS) severe caries experience status (dmft>=4)
Time Frame
Month 6 visit and Month 12 visit
Title
Past year dental visit
Description
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
Time Frame
Month 6 visit and Month 12 visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
47 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart Gansky, DrPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francisco Ramos-Gomez, DDS, MS, MPH
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Venice Family Clinic Children First Early Head Start
City
Santa Monica
State/Province
California
ZIP/Postal Code
90405-1828
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data will be made available.
IPD Sharing Time Frame
Specifics are undecided but will be in accordance with NIH rules
IPD Sharing URL
https://datadryad.org/
Citations:
PubMed Identifier
33090505
Citation
Ramos-Gomez F, White JS, Lindau HE, Lin TK, Finlayson TL, Liu JX, Gansky SA. Family monetary incentives as a value-based care model for oral hygiene: rationale and design of the BEhavioral EConomics for Oral health iNnovation (BEECON) trial. J Public Health Dent. 2020 Oct 8:10.1111/jphd.12406. doi: 10.1111/jphd.12406. Online ahead of print.
Results Reference
derived

Learn more about this trial

BEhavioral EConomics for Oral Health iNnovation Trial

We'll reach out to this number within 24 hrs