Status:

COMPLETED

BEhavioral EConomics for Oral Health iNnovation Pilot Trial

Lead Sponsor:

University of California, San Francisco

Collaborating Sponsors:

University of California, Los Angeles

Conditions:

Toothbrushing

Dental Plaque

Eligibility:

All Genders

6-42 years

Phase:

NA

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)...

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 the...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    May 10 2017

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 19 2018

    Estimated Enrollment :

    36 Patients enrolled

    Trial Details

    Trial ID

    NCT03862443

    Start Date

    May 10 2017

    End Date

    March 19 2018

    Last Update

    March 5 2019

    Active Locations (1)

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    Venice Family Clinic Children First Early Head Start

    Santa Monica, California, United States, 90405-1828