- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03862443
BEhavioral EConomics for Oral Health iNnovation Pilot Trial (BEECON Pilot)
March 1, 2019 updated by: University of California, San Francisco
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Santa Monica, California, United States, 90405-1828
- Venice Family Clinic Children First Early Head Start
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 3 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fixed Incentive
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.
|
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.
|
Experimental: Drawing Incentive
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).
|
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.
|
No Intervention: Control - Delayed Incentive
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.)
|
Baseline visit through the Month 2 visit
|
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.
|
Month 2 visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of weeks the parent/caregiver synced toothbrushing data with the app
Time Frame: Baseline visit through Month 2 visit
|
Proportion of weeks the parent/caregiver synced toothbrushing data with the app
|
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
|
Twice daily brushing with fluoridated toothpaste, based on parent/caregiver-reported frequency diaries
|
Baseline visit through the Month 2 visit
|
Fluoridated toothpaste use
Time Frame: Baseline visit through the Month 2 visit
|
Change in child toothpaste pump weight
|
Baseline visit through the Month 2 visit
|
Child plaque score
Time Frame: Month 2 visit
|
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).
|
Month 2 visit
|
EHS site participation
Time Frame: Month 0
|
Willingness of LA County EHS to sign memoranda of understanding
|
Month 0
|
EHS staff participation
Time Frame: Month 0
|
Willingness of EHS staff participation in assisting with recruitment
|
Month 0
|
Proportion of parents/caregivers who consent
Time Frame: Baseline visit
|
Willingness of parents/caregivers to provide informed consent and approve access to ChildPlus dental visit data
|
Baseline visit
|
Proportion of parents/caregivers willing to be randomized
Time Frame: Baseline visit
|
Willingness of parents/caregivers to be randomized to a study arm as part of the consenting process
|
Baseline visit
|
Proportion of parents/caregivers adhering to study procedures
Time Frame: Baseline visit through the Month 2 visit
|
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
|
Baseline visit through the Month 2 visit
|
Proportion of children who cooperate
Time Frame: Baseline visit through the Month 2 visit
|
Willingness of child to cooperate with study procedures, including dental screening, extraoral photo, and plaque assessment
|
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
|
Willingness to use the toothpaste pump (percentage with any use and percentage change in pump weight)
|
Baseline visit through the Month 2 visit
|
Feasibility of measuring toothbrushing frequency with diaries
Time Frame: Month 2 visit
|
Bringing toothbrushing diaries to the follow-up visit and willingness to provide them to study staff
|
Month 2 visit
|
Feasibility of using toothpaste pump weight as a measure of usage
Time Frame: Month 2 visit
|
Bringing the toothpaste pump to the follow-up visit for weighing
|
Month 2 visit
|
Proportion of parents/caregivers willing to use the disclosing solution
Time Frame: Baseline visit and Month 2 visit
|
Willingness of children to comply with the plaque disclosing procedure
|
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
|
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
|
Baseline visit and Month 2 visit
|
Proportion of parents/caregivers willing to use smart powered toothbrush
Time Frame: Baseline visit through Month 2 visit
|
Willingness to use the smart powered toothbrush handle (percentage with any brushing data)
|
Baseline visit through Month 2 visit
|
Comfort with smart powered toothbrush
Time Frame: Baseline visit through Month 2 visit
|
Child and parent comfort level with using the smart powered toothbrush
|
Baseline visit through Month 2 visit
|
Proportion of parents/caregivers willing to use smartphone app
Time Frame: Baseline visit
|
Willingness to download the smartphone app and keep it for the duration of the study
|
Baseline visit
|
Proportion of parents/caregivers willing to receive text messages
Time Frame: Baseline visit
|
Willingness to be contacted with study-related text messages each week during the intervention period
|
Baseline visit
|
Feasibility of syncing toothbrush to app
Time Frame: Baseline visit
|
Successfully synced the toothbrush to app during baseline visit
|
Baseline visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: James G Kahn, MD, MPH, University of California, San Francisco
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 10, 2017
Primary Completion (Actual)
August 13, 2017
Study Completion (Actual)
March 19, 2018
Study Registration Dates
First Submitted
February 14, 2019
First Submitted That Met QC Criteria
March 1, 2019
First Posted (Actual)
March 5, 2019
Study Record Updates
Last Update Posted (Actual)
March 5, 2019
Last Update Submitted That Met QC Criteria
March 1, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-19968
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dental Caries
-
Ain Shams UniversityCompletedPulpitis | Caries | Caries,Dental | Reversible Pulpitis | Caries Class I | Caries; DentinEgypt
-
National University of San Marcos, PeruNot yet recruitingPit and Fissure Caries | Caries,Dental | Sealant DentalPeru
-
University of MinnesotaCompletedUsing Motivational Interviewing To Reduce Parental Risk-Related Behaviors For Early Childhood CariesCaries | Caries,DentalUnited States
-
3MUniversity of MichiganActive, not recruiting
-
Hue University of Medicine and PharmacyRecruitingOcclusal Caries | Caries,Dental | Caries; InitialVietnam
-
Rawda Hesham Abd ElAzizRecruitingCaries,Dental | Caries Class IIEgypt
-
The University of Texas Health Science Center,...National Institute of Dental and Craniofacial Research (NIDCR)RecruitingCaries,DentalUnited States
-
Federal University of PelotasRecruiting
-
Kompetansesenteret Tannhelse Midt (TkMidt)Karolinska Institutet; University of Bergen; Norwegian University of Science... and other collaboratorsActive, not recruiting
-
Marmara UniversityCompleted
Clinical Trials on Fixed Incentive
-
Imperial College LondonNational Health Service, United KingdomCompletedDiabetes | Diabetic Retinopathy
-
University of PennsylvaniaNational Institute on Aging (NIA)Completed
-
Simon GregsonNational Institute of Mental Health (NIMH); University of Copenhagen; London... and other collaboratorsCompleted
-
University of California, San FranciscoNational Institute of Mental Health (NIMH); University of Pennsylvania; Makerere...Completed
-
Nationwide Children's HospitalCompleted
-
Emory UniversityCompleted
-
University of PennsylvaniaCompleted
-
Johns Hopkins Bloomberg School of Public HealthIfakara Health Institute; Pontificia Universidad Javeriana; The Bloomberg Family...CompletedNoncommunicable Diseases | Surveys and QuestionnairesTanzania, Colombia
-
University of PennsylvaniaDeloitteCompletedObesityUnited States
-
Carnegie Mellon UniversityUniversity of VirginiaCompletedSocial Isolation | Activity, MotorUnited States