BEhavioral EConomics for Oral Health iNnovation Pilot Trial

University of California, San Francisco36 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Toothbrushing Dental Plaque Parent-Child Relations Oral Hygiene

Interventions

Fixed IncentiveBEHAVIORAL

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 IncentiveBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 42 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Venice Family Clinic Children First Early Head Start

Santa Monica, California, United States

Outcomes

Primary Outcomes

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.)

Time frame: 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.

Time frame: Month 2 visit

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

Twice daily brushing with fluoridated toothpaste, based on parent/caregiver-reported frequency diaries

Time frame: Baseline visit through the Month 2 visit

Fluoridated toothpaste use

Change in child toothpaste pump weight

Time frame: 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).

Time frame: Month 2 visit

EHS site participation

Willingness of LA County EHS to sign memoranda of understanding

Time frame: Month 0

EHS staff participation

Willingness of EHS staff participation in assisting with recruitment

Time frame: Month 0

Proportion of parents/caregivers who consent

Willingness of parents/caregivers to provide informed consent and approve access to ChildPlus dental visit data

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: Month 2 visit

Proportion of parents/caregivers willing to use the disclosing solution

Willingness of children to comply with the plaque disclosing procedure

Time frame: 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

Time frame: 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)

Time frame: Baseline visit through Month 2 visit

Comfort with smart powered toothbrush

Child and parent comfort level with using the smart powered toothbrush

Time frame: 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

Time frame: 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

Time frame: Baseline visit

Feasibility of syncing toothbrush to app

Successfully synced the toothbrush to app during baseline visit

Time frame: Baseline visit

Data from ClinicalTrials.gov

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