BEhavioral EConomics for Oral Health iNnovation Pilot Trial

Dental Caries Clinical Trial

— BEECON Pilot  

Official title:

Influence of Financial Incentives on Oral Disease Management in Young Children: A Randomized Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03862443
• Other study ID #: 16-19968
• Status: Completed
• Phase: N/A
• Start date: May 10, 2017
• Est. completion date: March 19, 2018

Study information

• Verified date: March 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 predominantly Latino parents/caregivers enrolled in/waitlisted for Early Head Start (EHS) home visit programs.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 19, 2018
• Est. primary completion date: August 13, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 42 Months

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Fixed Incentive
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 Incentive
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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.)	Baseline visit through the Month 2 visit
Primary	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.	Month 2 visit
Secondary	Proportion of weeks the parent/caregiver synced toothbrushing data with the app	Proportion of weeks the parent/caregiver synced toothbrushing data with the app	Baseline visit through Month 2 visit
Secondary	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	Baseline visit through the Month 2 visit
Secondary	Fluoridated toothpaste use	Change in child toothpaste pump weight	Baseline visit through the Month 2 visit
Secondary	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).	Month 2 visit
Secondary	EHS site participation	Willingness of LA County EHS to sign memoranda of understanding	Month 0
Secondary	EHS staff participation	Willingness of EHS staff participation in assisting with recruitment	Month 0
Secondary	Proportion of parents/caregivers who consent	Willingness of parents/caregivers to provide informed consent and approve access to ChildPlus dental visit data	Baseline visit
Secondary	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	Baseline visit
Secondary	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	Baseline visit through the Month 2 visit
Secondary	Proportion of children who cooperate	Willingness of child to cooperate with study procedures, including dental screening, extraoral photo, and plaque assessment	Baseline visit through the Month 2 visit
Secondary	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)	Baseline visit through the Month 2 visit
Secondary	Feasibility of measuring toothbrushing frequency with diaries	Bringing toothbrushing diaries to the follow-up visit and willingness to provide them to study staff	Month 2 visit
Secondary	Feasibility of using toothpaste pump weight as a measure of usage	Bringing the toothpaste pump to the follow-up visit for weighing	Month 2 visit
Secondary	Proportion of parents/caregivers willing to use the disclosing solution	Willingness of children to comply with the plaque disclosing procedure	Baseline visit and Month 2 visit
Secondary	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	Baseline visit and Month 2 visit
Secondary	Proportion of parents/caregivers willing to use smart powered toothbrush	Willingness to use the smart powered toothbrush handle (percentage with any brushing data)	Baseline visit through Month 2 visit
Secondary	Comfort with smart powered toothbrush	Child and parent comfort level with using the smart powered toothbrush	Baseline visit through Month 2 visit
Secondary	Proportion of parents/caregivers willing to use smartphone app	Willingness to download the smartphone app and keep it for the duration of the study	Baseline visit
Secondary	Proportion of parents/caregivers willing to receive text messages	Willingness to be contacted with study-related text messages each week during the intervention period	Baseline visit
Secondary	Feasibility of syncing toothbrush to app	Successfully synced the toothbrush to app during baseline visit	Baseline visit