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Completed

NCT Number: NCT03862443

BEhavioral EConomics for Oral Health iNnovation 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.

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Key information

Conditions

Toothbrushing Behavior Dental Caries Dental Deposits Dental Plaque Health Behavior Oral Hygiene Parent-Child Relations Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

6 month–42 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Venice Family Clinic Children First Early Head Start

Santa Monica, California, 90405-1828, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.)

  2. 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.

Secondary outcomes

  1. 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

  2. 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

  3. Fluoridated toothpaste use

    Time frame: Baseline visit through the Month 2 visit

    Change in child toothpaste pump weight

  4. 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).

  5. EHS site participation

    Time frame: Month 0

    Willingness of LA County EHS to sign memoranda of understanding

  6. EHS staff participation

    Time frame: Month 0

    Willingness of EHS staff participation in assisting with recruitment

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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)

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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)

  17. Comfort with smart powered toothbrush

    Time frame: Baseline visit through Month 2 visit

    Child and parent comfort level with using the smart powered toothbrush

  18. 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

  19. 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

  20. Feasibility of syncing toothbrush to app

    Time frame: Baseline visit

    Successfully synced the toothbrush to app during baseline visit

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • University of California, Los Angeles

Registry information

Official study title

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

Acronym: BEECON Pilot

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Mar 5, 2019
Registry last updated
Mar 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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