BEhavioral EConomics for Oral Health iNnovation Pilot Trial

NCT03862443 | Completed

• 1 other identifier: 16-19968
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Preventive Dentistry; Health Disparities; Health Behavior; Behavioral Economics; Monetary Incentives

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (20)

• 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

  Baseline visit through the Month 2 visit

• Fluoridated toothpaste use

  Baseline visit through the Month 2 visit

• Child plaque score

  Month 2 visit

• EHS site participation

  Month 0

Study Arms (3)

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.

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).

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.

Interventions

Fixed Incentive BEHAVIORAL

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.

Fixed Incentive

Drawing Incentive BEHAVIORAL

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.

Drawing Incentive

Eligibility Criteria

• Age: 6 Months - 42 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of California, Los Angeles: collaborator

Study Sites (1)

Venice Family Clinic Children First Early Head Start

Santa Monica, California, 90405-1828, United States

Location

Related Publications (1)

• 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.

  PMID: 32730310 DERIVED

MeSH Terms

Conditions

Dental Plaque; Dental Caries; Health Behavior

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Tooth Demineralization; Behavior

Study Officials

• Stuart A Gansky, DrPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Francisco Ramos-Gomez, DDS, MS, MPH

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• James G Kahn, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: March 5, 2019
• Study Start: May 10, 2017
• Primary Completion: August 13, 2017
• Study Completion: March 19, 2018
• Last Updated: March 5, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)