ToothbrushingBEECON PilotNCT03862443
BEhavioral EConomics for Oral Health iNnovation Pilot Trial
A study testing Fixed Incentive and Drawing Incentive in people with Toothbrushing and Dental Plaque, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 42 monthsHealthy volunteers can take part
- Conditions the study is for
- Toothbrushing, Dental Plaque, Parent-Child Relations
- What is being tested?
- Fixed Incentive and Drawing Incentive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2017to 19 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 42 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Venice Family Clinic Children First Early Head Start
Santa Monica, California, 90405-1828
About this study
Official title: Influence of Financial Incentives on Oral Disease Management in Young Children: A Randomized Pilot Trial
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.
Read the 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.
- Being tested
- Fixed Incentive, Drawing Incentive
- Keywords
- Preventive Dentistry, Health Disparities, Health Behavior, Behavioral Economics, Monetary Incentives
- Medical subject headings
- Dental Plaque, Dental Caries, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed IncentiveBehavioural
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.
Drawing IncentiveBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Fixed Incentive | Experimental | 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. Receives: Behavioral: Fixed Incentive |
| Drawing Incentive | Experimental | 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). Receives: Behavioral: Drawing Incentive |
| Control - Delayed Incentive | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: Baseline visit through the Month 2 visit
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.
Measured: Month 2 visit
Secondary outcomes (20)
Proportion of weeks the parent/caregiver synced toothbrushing data with the app
Proportion of weeks the parent/caregiver synced toothbrushing data with the app
Measured: Baseline visit through Month 2 visit
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
Measured: Baseline visit through the Month 2 visit
Fluoridated toothpaste use
Change in child toothpaste pump weight
Measured: Baseline visit through the Month 2 visit
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).
Measured: Month 2 visit
EHS site participation
Willingness of LA County EHS to sign memoranda of understanding
Measured: Month 0
EHS staff participation
Willingness of EHS staff participation in assisting with recruitment
Measured: Month 0
Proportion of parents/caregivers who consent
Willingness of parents/caregivers to provide informed consent and approve access to ChildPlus dental visit data
Measured: Baseline visit
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
Measured: Baseline visit
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
Measured: Baseline visit through the Month 2 visit
Proportion of children who cooperate
Willingness of child to cooperate with study procedures, including dental screening, extraoral photo, and plaque assessment
Measured: Baseline visit through the Month 2 visit
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)
Measured: Baseline visit through the Month 2 visit
Feasibility of measuring toothbrushing frequency with diaries
Bringing toothbrushing diaries to the follow-up visit and willingness to provide them to study staff
Measured: Month 2 visit
Feasibility of using toothpaste pump weight as a measure of usage
Bringing the toothpaste pump to the follow-up visit for weighing
Measured: Month 2 visit
Proportion of parents/caregivers willing to use the disclosing solution
Willingness of children to comply with the plaque disclosing procedure
Measured: Baseline visit and Month 2 visit
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
Measured: Baseline visit and Month 2 visit
Proportion of parents/caregivers willing to use smart powered toothbrush
Willingness to use the smart powered toothbrush handle (percentage with any brushing data)
Measured: Baseline visit through Month 2 visit
Comfort with smart powered toothbrush
Child and parent comfort level with using the smart powered toothbrush
Measured: Baseline visit through Month 2 visit
Proportion of parents/caregivers willing to use smartphone app
Willingness to download the smartphone app and keep it for the duration of the study
Measured: Baseline visit
Proportion of parents/caregivers willing to receive text messages
Willingness to be contacted with study-related text messages each week during the intervention period
Measured: Baseline visit
Feasibility of syncing toothbrush to app
Successfully synced the toothbrush to app during baseline visit
Measured: Baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start10 May 2017
- Primary completion13 Aug 2017
- Study completion19 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ToothbrushingStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Responsible party
- Sponsor
- Investigators
- Stuart A Gansky, DrPH, Principal investigator, University of California, San FranciscoFrancisco Ramos-Gomez, DDS, MS, MPH, Principal investigator, University of California, Los AngelesJames G Kahn, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03862443
- Sponsor's protocol ID
- 16-19968
- Acronym
- BEECON Pilot
- Status last verified
- Mar 2019
- First submitted
- 14 Feb 2019
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32730310
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Financial Incentives on Oral Disease Management in Young Children: A Randomized Pilot Trial
- ClinicalTrials.gov ID
- NCT03862443
- Acronym / sponsor ID
- BEECON Pilot / 16-19968
- Keywords
- Preventive Dentistry, Health Disparities, Health Behavior, Behavioral Economics, Monetary Incentives
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- 10 May 2017 (actual)
- Primary completion
- 13 Aug 2017 (actual)
- Study completion
- 19 Mar 2018 (actual)
- First posted
- 5 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| Fixed Incentive | Experimental | Behavioral: Fixed 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. |
| Drawing Incentive | Experimental | Behavioral: Drawing 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). |
| Control - Delayed Incentive | No intervention | –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. |
Who may qualify
- Ages
- 6 to 42 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fixed IncentiveThe 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. | Behavioural | Fixed Incentive |
| Drawing IncentiveThe 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. | Behavioural | Drawing Incentive |
Primary outcome
Mean number of qualifying half-day toothbrushing episodes per week
Time frame: Baseline 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 visit
Time frame: Month 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.
20 secondary outcomes
Proportion of weeks the parent/caregiver synced toothbrushing data with the app
Time frame: Baseline visit through Month 2 visit
Mean number of days per week with parent/caregiver-reported twice daily brushing
Time frame: Baseline visit through the Month 2 visit
Fluoridated toothpaste use
Time frame: Baseline visit through the Month 2 visit
Child plaque score
Time frame: Month 2 visit
EHS site participation
Time frame: Month 0
EHS staff participation
Time frame: Month 0
Proportion of parents/caregivers who consent
Time frame: Baseline visit
Proportion of parents/caregivers willing to be randomized
Time frame: Baseline visit
Proportion of parents/caregivers adhering to study procedures
Time frame: Baseline visit through the Month 2 visit
Proportion of children who cooperate
Time frame: Baseline visit through the Month 2 visit
Proportion of parents/caregivers willing to use the toothpaste pump
Time frame: Baseline visit through the Month 2 visit
Feasibility of measuring toothbrushing frequency with diaries
Time frame: Month 2 visit
Feasibility of using toothpaste pump weight as a measure of usage
Time frame: Month 2 visit
Proportion of parents/caregivers willing to use the disclosing solution
Time frame: Baseline visit and Month 2 visit
Proportion of parents/caregivers willing to use photographs for central assessment
Time frame: Baseline visit and Month 2 visit
Proportion of parents/caregivers willing to use smart powered toothbrush
Time frame: Baseline visit through Month 2 visit
Comfort with smart powered toothbrush
Time frame: Baseline visit through Month 2 visit
Proportion of parents/caregivers willing to use smartphone app
Time frame: Baseline visit
Proportion of parents/caregivers willing to receive text messages
Time frame: Baseline visit
Feasibility of syncing toothbrush to app
Time frame: Baseline visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Derived from this study: PubMed 32730310White 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart A Gansky, DrPH principal investigator
University of California, San Francisco
Francisco Ramos-Gomez, DDS, MS, MPH principal investigator
University of California, Los Angeles
James G Kahn, MD, MPH principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fixed Incentive and Drawing Incentive in people with Toothbrushing and Dental Plaque, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean number of qualifying half-day toothbrushing episodes per week (time frame: Baseline visit through the Month 2 visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03862443, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.