BEhavioral EConomics for Oral Health iNnovation Trial (BEECON)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03576326|
Recruitment Status : Active, not recruiting
First Posted : July 3, 2018
Last Update Posted : April 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|Toothbrushing Dental Plaque Parent-Child Relations Oral Hygiene Dental Caries||Behavioral: Drawing Incentive||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||244 participants|
|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.)|
|Official Title:||Influence of Financial Incentives on Oral Disease Management in Young Children|
|Actual Study Start Date :||May 9, 2018|
|Estimated Primary Completion Date :||May 15, 2021|
|Estimated Study Completion Date :||June 30, 2021|
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.
- 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.)
- 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.
- 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.
- 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.
- 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
- 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
- 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.)
- 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)
- Change from Baseline in toothpaste weight [ Time Frame: From Baseline to Month 6 visit and From Month 6 visit to Month 12 visit ]Change in toothpaste pump weight (grams) from each distribution visit (6 months prior)
- 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)
- 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) caries experience status (dmft>0)
- 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) severe caries experience status (dmft>=4)
- 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
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
|United States, California|
|Venice Family Clinic Children First Early Head Start|
|Santa Monica, California, United States, 90405-1828|
|Principal Investigator:||Stuart Gansky, DrPH||University of California, San Francisco|
|Principal Investigator:||Francisco Ramos-Gomez, DDS, MS, MPH||University of California, Los Angeles|