Back to resultsBEhavioral EConomics for Oral Health iNnovation Pilot Trial (BEECON Pilot)
Primary Purpose
Toothbrushing, Dental Plaque, Parent-Child Relations
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fixed Incentive
Drawing Incentive
Sponsored by
About this trial
This is an interventional prevention trial for Toothbrushing focused on measuring Preventive Dentistry, Health Disparities, Health Behavior, Behavioral Economics, Monetary Incentives
Eligibility Criteria
Inclusion Criteria for 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 visit.
- Male or female, aged 18 and older.
- Speak, read, and write either English or Spanish.
- Be a parent or caregiver of a child at least 6 months old but less than 3.5 years (42 months), with at least 2 fully erupted teeth and enrolled in, or waitlisted for, one of the three participating Los Angeles County EHS home visit programs.
- Not be planning to move residence for the next 6 months outside the greater Los Angeles area.
- Own a smartphone with the Google Play or iTunes store and be willing to download the smart powered TB app
- Be willing to be contacted via text-messaging (SMS) for study related notifications, such as incentives earned or reminders to sync the TB
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.
Sites / Locations
- Venice Family Clinic Children First Early Head Start
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Fixed Incentive
Drawing Incentive
Control - Delayed Incentive
Arm Description
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.
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).
No rewards during the first 2-months, but information on toothbrushing performance collected through smart powered toothbrush synced to a smartphone app. After the Month 2 follow-up visit, may opt to participate in a delayed 2-month open label extension to earn the same monetary rewards the fixed incentive intervention group could earn Baseline through Month 2. 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
Mean number of qualifying half-day toothbrushing episodes per week
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
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
Proportion of weeks the parent/caregiver synced toothbrushing data with the app
Proportion of weeks the parent/caregiver synced toothbrushing data with the app
Mean number of days per week with parent/caregiver-reported twice daily brushing
Twice daily brushing with fluoridated toothpaste, based on parent/caregiver-reported frequency diaries
Fluoridated toothpaste use
Change in child toothpaste pump weight
Child plaque score
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).
EHS site participation
Willingness of LA County EHS to sign memoranda of understanding
EHS staff participation
Willingness of EHS staff participation in assisting with recruitment
Proportion of parents/caregivers who consent
Willingness of parents/caregivers to provide informed consent and approve access to ChildPlus dental visit data
Proportion of parents/caregivers willing to be randomized
Willingness of parents/caregivers to be randomized to a study arm as part of the consenting process
Proportion of parents/caregivers adhering to study procedures
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 children who cooperate
Willingness of child to cooperate with study procedures, including dental screening, extraoral photo, and plaque assessment
Proportion of parents/caregivers willing to use the toothpaste pump
Willingness to use the toothpaste pump (percentage with any use and percentage change in pump weight)
Feasibility of measuring toothbrushing frequency with diaries
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
Bringing the toothpaste pump to the follow-up visit for weighing
Proportion of parents/caregivers willing to use the disclosing solution
Willingness of children to comply with the plaque disclosing procedure
Proportion of parents/caregivers willing to use photographs for central assessment
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
Proportion of parents/caregivers willing to use smart powered toothbrush
Willingness to use the smart powered toothbrush handle (percentage with any brushing data)
Comfort with smart powered toothbrush
Child and parent comfort level with using the smart powered toothbrush
Proportion of parents/caregivers willing to use smartphone app
Willingness to download the smartphone app and keep it for the duration of the study
Proportion of parents/caregivers willing to receive text messages
Willingness to be contacted with study-related text messages each week during the intervention period
Feasibility of syncing toothbrush to app
Successfully synced the toothbrush to app during baseline visit
Full Information
NCT ID
NCT03862443
First Posted
February 14, 2019
Last Updated
March 1, 2019
Sponsor
University of California, San Francisco
Collaborators
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT03862443
Brief Title
BEhavioral EConomics for Oral Health iNnovation Pilot Trial
Acronym
BEECON Pilot
Official Title
Influence of Financial Incentives on Oral Disease Management in Young Children: A Randomized Pilot Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
May 10, 2017 (Actual)
Primary Completion Date
August 13, 2017 (Actual)
Study Completion Date
March 19, 2018 (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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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, Monetary Incentives
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 three arms. Strata will be based on 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
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fixed Incentive
Arm Type
Experimental
Arm Description
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.
Arm Title
Drawing Incentive
Arm Type
Experimental
Arm Description
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).
Arm Title
Control - Delayed Incentive
Arm Type
No Intervention
Arm Description
No rewards during the first 2-months, but information on toothbrushing performance collected through smart powered toothbrush synced to a smartphone app. After the Month 2 follow-up visit, may opt to participate in a delayed 2-month open label extension to earn the same monetary rewards the fixed incentive intervention group could earn Baseline through Month 2. 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)
Fixed Incentive
Intervention Description
The Fixed Incentive intervention is a fixed reward, in which participants are eligible for fixed weekly payments based on toothbrushing performance collected through smart powered toothbrush synced to a smartphone app.
Intervention Type
Behavioral
Intervention Name(s)
Drawing Incentive
Intervention Description
The Drawing Incentive intervention is a drawing reward, in which participants are eligible for weekly payments based on toothbrushing performance collected through smart powered toothbrush synced to a smartphone app.
Primary Outcome Measure Information:
Title
Mean number of qualifying half-day toothbrushing episodes per week
Description
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.)
Time Frame
Baseline visit through the Month 2 visit
Title
Proportion of parents/caregivers attending a dental visit
Description
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.
Time Frame
Month 2 visit
Secondary Outcome Measure Information:
Title
Proportion of weeks the parent/caregiver synced toothbrushing data with the app
Description
Proportion of weeks the parent/caregiver synced toothbrushing data with the app
Time Frame
Baseline visit through Month 2 visit
Title
Mean number of days per week with parent/caregiver-reported twice daily brushing
Description
Twice daily brushing with fluoridated toothpaste, based on parent/caregiver-reported frequency diaries
Time Frame
Baseline visit through the Month 2 visit
Title
Fluoridated toothpaste use
Description
Change in child toothpaste pump weight
Time Frame
Baseline visit through the Month 2 visit
Title
Child plaque score
Description
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).
Time Frame
Month 2 visit
Title
EHS site participation
Description
Willingness of LA County EHS to sign memoranda of understanding
Time Frame
Month 0
Title
EHS staff participation
Description
Willingness of EHS staff participation in assisting with recruitment
Time Frame
Month 0
Title
Proportion of parents/caregivers who consent
Description
Willingness of parents/caregivers to provide informed consent and approve access to ChildPlus dental visit data
Time Frame
Baseline visit
Title
Proportion of parents/caregivers willing to be randomized
Description
Willingness of parents/caregivers to be randomized to a study arm as part of the consenting process
Time Frame
Baseline visit
Title
Proportion of parents/caregivers adhering to study procedures
Description
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
Time Frame
Baseline visit through the Month 2 visit
Title
Proportion of children who cooperate
Description
Willingness of child to cooperate with study procedures, including dental screening, extraoral photo, and plaque assessment
Time Frame
Baseline visit through the Month 2 visit
Title
Proportion of parents/caregivers willing to use the toothpaste pump
Description
Willingness to use the toothpaste pump (percentage with any use and percentage change in pump weight)
Time Frame
Baseline visit through the Month 2 visit
Title
Feasibility of measuring toothbrushing frequency with diaries
Description
Bringing toothbrushing diaries to the follow-up visit and willingness to provide them to study staff
Time Frame
Month 2 visit
Title
Feasibility of using toothpaste pump weight as a measure of usage
Description
Bringing the toothpaste pump to the follow-up visit for weighing
Time Frame
Month 2 visit
Title
Proportion of parents/caregivers willing to use the disclosing solution
Description
Willingness of children to comply with the plaque disclosing procedure
Time Frame
Baseline visit and Month 2 visit
Title
Proportion of parents/caregivers willing to use photographs for central assessment
Description
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
Time Frame
Baseline visit and Month 2 visit
Title
Proportion of parents/caregivers willing to use smart powered toothbrush
Description
Willingness to use the smart powered toothbrush handle (percentage with any brushing data)
Time Frame
Baseline visit through Month 2 visit
Title
Comfort with smart powered toothbrush
Description
Child and parent comfort level with using the smart powered toothbrush
Time Frame
Baseline visit through Month 2 visit
Title
Proportion of parents/caregivers willing to use smartphone app
Description
Willingness to download the smartphone app and keep it for the duration of the study
Time Frame
Baseline visit
Title
Proportion of parents/caregivers willing to receive text messages
Description
Willingness to be contacted with study-related text messages each week during the intervention period
Time Frame
Baseline visit
Title
Feasibility of syncing toothbrush to app
Description
Successfully synced the toothbrush to app during baseline visit
Time Frame
Baseline visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
42 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for 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 visit.
Male or female, aged 18 and older.
Speak, read, and write either English or Spanish.
Be a parent or caregiver of a child at least 6 months old but less than 3.5 years (42 months), with at least 2 fully erupted teeth and enrolled in, or waitlisted for, one of the three participating Los Angeles County EHS home visit programs.
Not be planning to move residence for the next 6 months outside the greater Los Angeles area.
Own a smartphone with the Google Play or iTunes store and be willing to download the smart powered TB app
Be willing to be contacted via text-messaging (SMS) for study related notifications, such as incentives earned or reminders to sync the TB
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart A 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
First Name & Middle Initial & Last Name & Degree
James G Kahn, MD, MPH
Organizational Affiliation
University of California, San Francisco
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
No
Citations:
PubMed Identifier
32730310
Citation
White JS, Ramos-Gomez F, Liu JX, Jue B, Finlayson TL, Garza JR, Crawford AH, Helman S, Santo W, Cheng J, Kahn JG, Gansky SA. Monetary incentives for improving smartphone-measured oral hygiene behaviors in young children: A randomized pilot trial. PLoS One. 2020 Jul 30;15(7):e0236692. doi: 10.1371/journal.pone.0236692. eCollection 2020.
Results Reference
derived
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BEhavioral EConomics for Oral Health iNnovation Pilot Trial
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