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BEhavioral EConomics for Oral Health iNnovation Pilot Trial (BEECON Pilot)

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ClinicalTrials.gov Identifier: NCT03862443
Recruitment Status : Completed
First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Toothbrushing Dental Plaque Parent-Child Relations Oral Hygiene Dental Caries Behavioral: Fixed Incentive Behavioral: Drawing Incentive Not Applicable

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 they are similar, the fixed monetary reward will be used because it is simpler to explain, monitor, and implement.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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).
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: 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.)
Primary Purpose: Prevention
Official Title: Influence of Financial Incentives on Oral Disease Management in Young Children: A Randomized Pilot Trial
Actual Study Start Date : May 10, 2017
Actual Primary Completion Date : August 13, 2017
Actual Study Completion Date : March 19, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
Experimental: Fixed Incentive
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
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.

Experimental: Drawing Incentive
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
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.

No Intervention: Control - Delayed Incentive
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 42 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03862443


Locations
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United States, California
Venice Family Clinic Children First Early Head Start
Santa Monica, California, United States, 90405-1828
Sponsors and Collaborators
University of California, San Francisco
University of California, Los Angeles
Investigators
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Principal Investigator: 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

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03862443     History of Changes
Other Study ID Numbers: 16-19968
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, San Francisco:
Preventive Dentistry
Health Disparities
Health Behavior
Behavioral Economics
Monetary Incentives

Additional relevant MeSH terms:
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Dental Caries
Dental Plaque
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Dental Deposits