BEhavioral EConomics for Oral Health iNnovation Pilot Trial

NCT ID: NCT03862443

Last Updated: 2019-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-10
• Study Completion Date: 2018-03-19

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.

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.

Conditions

Toothbrushing; Dental Plaque; Parent-Child Relations; Oral Hygiene; Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Fixed Incentive

Intervention Type: 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

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).

Group Type: EXPERIMENTAL

Drawing Incentive

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 42 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stuart A Gansky, DrPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Francisco Ramos-Gomez, DDS, MS, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

James G Kahn, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Venice Family Clinic Children First Early Head Start

Santa Monica, California, United States

Countries

United States

References

White JS, Ramos-Gomez F, Liu JX, Jue B, Finlayson TL, Garza JR, Crawford AH, Helman S, Santo W, Cheng J, Kahn JG, Gansky SA. Monetary incentives for improving smartphone-measured oral hygiene behaviors in young children: A randomized pilot trial. PLoS One. 2020 Jul 30;15(7):e0236692. doi: 10.1371/journal.pone.0236692. eCollection 2020.

Reference Type: DERIVED

PMID: 32730310 (View on PubMed)

Other Identifiers

16-19968

Identifier Type: -

Identifier Source: org_study_id