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BEhavioral EConomics for Oral Health iNnovation Trial (BEECON)

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ClinicalTrials.gov Identifier: NCT03576326
Recruitment Status : Recruiting
First Posted : July 3, 2018
Last Update Posted : July 9, 2018
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
This Phase II stratified randomized prevention trial will assess the efficacy of a behavioral economic theory-based financial incentive drawing program versus a control regimen to promote early childhood caries (ECC) preventive health behaviors (toothbrushing performance) for young children of predominantly Latino parents/caregivers in Early Head Start (EHS) and day care center programs.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 244 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 two arms. Strata will be based on site and 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
Actual Study Start Date : May 9, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Arm Intervention/treatment
Experimental: Incentive Drawing
Eligible to earn a weekly drawing entry with different winning probabilities during the 6-month incentive intervention period. Possible winnings depend on toothbrushing performance: 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 Monetary Reward intervention is a drawing reward, in which participants are eligible for weekly rewards based on toothbrushing performance.

No Intervention: Control - Delayed Incentive
No rewards during the first 12 months, but information on toothbrushing performance. After the Month 12 follow-up visit, may opt to participate in a delayed 6-month open label extension to earn the same monetary rewards the intervention group could earn Baseline through Month 6. 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. Toothbrushing performance [ Time Frame: Baseline visit through the Month 6 visit ]
    Mean of the 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.)


Secondary Outcome Measures :
  1. Short-term (immediate) toothbrushing performance [ Time Frame: Baseline visit through the Month 1 visit ]
    Mean number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth.

  2. Mid-term toothbrushing performance [ Time Frame: Baseline visit through the Month 3 visit ]
    Mean number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth.

  3. Toothbrushing performance sustainability [ Time Frame: Month 6 visit through the Month 12 visit ]
    Mean number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth.

  4. Cost-effectiveness ratio [ Time Frame: 1, 2, 5, 10, and 20 years ]
    Short- and long-term incremental cost effectiveness ratios (ICERs) improving parent/caregiver toothbrushing performance relative to cost

  5. Cost-effectiveness return on investment [ Time Frame: 1, 2, 5, 10, and 20 years ]
    Short- and long-term return on investment (ROI) comparing intervention program costs versus future treatment costs averted

  6. Self-efficacy scale [ Time Frame: Baseline visit through Month 6 visit ]
    Oral health self-efficacy items (total score ranges 6-30 with higher score indicating more self-efficacy; 6 items each on 1-5 ordinal scale, Albino et al.; Finlayson et al.)

  7. Modified Simplified Oral Hygiene Index [ Time Frame: Month 6 visit and Month 12 visit ]
    Debris Index of the Simplified Oral Hygiene Index for Maxillary Incisors (OHI-MIS) to measure plaque on primary maxillary incisor facial (labial) tooth surfaces (mean of 4 ordinal scores)

  8. Change from Baseline in toothpaste weight [ Time Frame: From Baseline to Month 6 visit and From Baseline to Month 12 visit ]
    Change in toothpaste pump weight (grams) from the Baseline visit

  9. Untreated caries [ Time Frame: Month 6 visit and Month 12 visit ]
    Binary measure of Association of State and Territorial Dental Directors Basic Screening Survey (ASTDD BSS) untreated caries status (dt>0)

  10. Caries experience [ Time Frame: Month 6 visit and Month 12 visit ]
    Binary measure of Association of State and Territorial Dental Directors Basic Screening Survey (ASTDD BSS) untreated caries status (dmft>0)

  11. Severe caries [ Time Frame: Month 6 visit and Month 12 visit ]
    Binary measure of Association of State and Territorial Dental Directors Basic Screening Survey (ASTDD BSS) untreated caries status (dmft>=4)

  12. Past year dental visit [ Time Frame: Month 6 visit and Month 12 visit ]
    Binary measure of a dental visit in the past 12 months, obtained through Early Head Start ChildPlus database which records annual dental visit and other required health screenings



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Months to 47 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Child

    • at least 2 fully erupted teeth
    • enrolled in, or waitlisted for, one of the participating Los Angeles County Early Head Start (EHS) or affiliated day care center or area clinic programs
  • 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
    • aged 18 or older
    • speak either English or Spanish and self-reported ability to read and write either English or Spanish
    • be a parent or caregiver of a child at least 6 months old but less than 4 years (48 months), with at least 2 fully erupted teeth and enrolled in, or waitlisted for, one of the participating Los Angeles County EHS or affiliated day care center or area clinic programs
    • not be planning to move residence for the next 18 months outside the greater Los Angeles area
    • own a smartphone with Google Play or iTunes store app and be willing to download and install the smart powered toothbrush app at the Screening visit and keep it installed for the duration of the project. [If the app cannot be properly installed by the baseline visit, the participant will not be randomized.]
    • be willing to be contacted via text-messaging (SMS) for study related notifications, such as incentives earned or reminders to sync the toothbrush
  • Stakeholder

    • be a staff member at a participating study site (e.g. EHS or affiliated day care center)
    • verbally agree to participate after being provided a study information sheet

Exclusion Criteria:

  • Child

    • known allergic reaction to components of the study product(s)
    • uncooperative or behaviorally unsuited (assessed during a toothbrush prophylaxis, ASTDD Basic Screening Survey caries screening, and photograph of maxillary incisors at the screening visit)
    • more than 2 crowns on maxillary incisor teeth (teeth# D, E, F, G, or equivalently #52, 51, 61, 62).
    • participated in the BEECON pilot trial
    • a sibling of a child 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
  • Parent/caregiver

    • participated in the BEECON pilot trial
    • unable or unwilling to install and use the smart powered toothbrush app during the run-in period

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): NCT03576326


Contacts
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Contact: Helen Lindau, MPH 424-371-6725 UCLA.BEECON@gmail.com
Contact: Francisco Ramos-Gomez, DDS, MS, MPH 310-825-9460 frg@dentistry.ucla.edu

Locations
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United States, California
Venice Family Clinic Children First Early Head Start Recruiting
Santa Monica, California, United States, 90405-1828
Contact: Helen Lindau, MPH    424-371-6725    UCLA.BEECON@gmail.com   
Sponsors and Collaborators
University of California, San Francisco
University of California, Los Angeles
Investigators
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Principal Investigator: Stuart Gansky, DrPH University of California, San Francisco
Principal Investigator: Francisco Ramos-Gomez, DDS, MS, MPH University of California, Los Angeles

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03576326     History of Changes
Other Study ID Numbers: NIDCR 17-084-E UH3DE025514
First Posted: July 3, 2018    Key Record Dates
Last Update Posted: July 9, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be made available.
Supporting Materials: Study Protocol
Time Frame: Specifics are undecided but will be in accordance with NIH rules
URL: http://datashare.ucsf.edu

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