Interactive Parent-Targeted Text Messaging in Pediatric Clinics to Reduce Caries Among Urban Children

NCT03294590 | Completed Results DMC

• 2 other identifiers: H-368574UH3DE025492-03
• Study Type: interventional
• Target: 754
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized clinical trial to test the efficacy of a parent-targeted text message-based intervention program on caries incidence and oral health behaviors (child and parent). Parents (n= 850) across all pediatric clinic sites (Boston Medical Center and Community Health Centers (CHCs); DotHouse CHC, South End Community Health Center, and Codman Square CHC) will be randomized to receive either text messages (TMs) regarding oral health or TMs regarding child wellness. The study will enroll English and Spanish speaking parents and their youngest child who is \< 7 years old, has at least one tooth showing, and attends the targeted pediatric clinic to receive primary care (n= 1700). Parents will complete self-report surveys at baseline, and 2, 4, 12, and 24-months after baseline; receive and respond to TM assessments during the 4-month intervention; and will also receive TMs during a 'booster' period of one month, which will occur 12-months post baseline. Parent's children will be assessed for caries by a clinical oral examination performed by licensed Clinical Examiners at baseline, 12-and-24-months post-baseline.

Conditions

Caries, Dental; Health Behavior

Keywords

Child oral health behaviors; Text messages; Motivation; Self efficacy; Outcome Expectations; Sugar sweetened beverage consumption; Fluoride varnish; Healthy eating; Parent oral health behaviors; Parent oral health attitudes; Fluoride; early childhood caries

Outcome Measures

Primary Outcomes (6)

• Dental Caries Increment

  Surface level caries data in children was collected by calibrated clinical examiners (blind to treatment condition), utilizing the OHDC Modified ICDAS methodology, will allow calculation of caries increment (development of a new cavitated lesion or filled surface on a previously sound tooth surface).

  24-month time point (oral assessment)

• Parent/Caregiver Confidence to Brush

  9-item self-efficacy measure to assess parent/caregiver participant confidence in their ability to brush their child's teeth under different situations. (Finlayson measure; range 1 - 4; higher scores mean better outcome)

  4-month time point (survey)

• Parent/Caregiver Motivation to Perform Oral Health Behaviors

  A oral health motivation measure to assess parent/caregiver participants motivation to engage in recommended child oral health behaviors (score range 1 - 7; higher scores mean better outcome)

  4-month time point (survey)

• Parent/Caregiver Outcome Expectations for Oral Health Behaviors

  An outcome expectancies measure to assess the degree to which parent/caregiver participants perceive that performing the oral health behaviors (e.g., brushing) will lead to the desired outcome (e.g., reduced dental caries) in their children (Stewart et al., 1997; range 1 - 4; higher scores mean better outcome).

  4-month time point (survey)

• Self-efficacy to Perform Oral Health Behaviors

  The overall self-efficacy score represents how sure parent/caregiver participants are that they can engage in recommended behavior to take care of their children's teeth. (Based on Albino et al 2017; range 1 - 7; higher scores mean better outcome).

  4-month time point (survey)

• Dental Caries Increment (Surface Level)

  Caries data in children participants collected by calibrated clinical examiners (blind to treatment condition), utilizing the OHDC Modified ICDAS methodology, will allow calculation of a surface of tooth-level caries increment (development of a new cavitated lesion or filled surface on a previously sound tooth surface).

  24-month time point (oral assessment)

Secondary Outcomes (16)

• Text Message Program Length Satisfaction

  4-month time point (survey)

• Parents' Perceived Impact of iSmile

  4-month time point (survey)

• Child Preventive Dental Visits

  4-month, 12-month, and 24-month time points (survey)

• Fluoridated Toothpaste Use

  4-month, 12-month, and 24-month time points (survey)

• Perceived Impact of OHT Program on Parental Awareness

  24-month (survey)

Other Outcomes (3)

• Type of Beverage Consumed Between Meals

  4-month, 12-month, and 24-month time points (survey)

• Challenge Week During the OHT Text Message Program

  4-month time point

• Dental Caries (Per Subject)

  24-Month (oral health assessment)

Study Arms (2)

Oral health text messages (OHT)

EXPERIMENTAL

Participants in this arm will receive the OHT parent targeted text messages to reduce caries and improve oral health behaviors among low income families visiting community-based, urban pediatric clinics.

Other: OHT Parent targeted text messages

Child wellness text messages (CWT)

ACTIVE COMPARATOR

Participants in this arm will receive the CWT parent targeted text messages to improve child wellness (e.g., reading time, safety) among low income families visiting community-based, urban pediatric clinics.

Other: CWT Parent targeted text messages

Interventions

OHT Parent targeted text messages OTHER

For the Oral health text message (OHT) group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to oral health.

Oral health text messages (OHT)

CWT Parent targeted text messages OTHER

For the CWT group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to child wellness.

Child wellness text messages (CWT)

Eligibility Criteria

• Age: 0 Months - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Caregiver must be a parent or legal guardian of a child less than 7 years old, and the child must have their first tooth showing
• The child must receive medical care at one of the participating pediatric clinics.
• Speak, understand, and read either English or Spanish
• Have a mobile phone.

You may not qualify if:

• Children with severe congenital tooth malformations: At screening the caregiver will be asked if their child has known systemic diseases associated with abnormal tooth development or abnormal oral health status such as cleft lip or palate, amelogenesis imperfecta, or dentinogenesis imperfecta.
• Children who cannot complete the baseline oral health exam.

Sponsors & Collaborators

• Boston University: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

• Borrelli B, Endrighi R, Heeren T, Adams WG, Gansky SA, Werntz S, Rueras N, Stephens D, Ameli N, Henshaw MM. Parent-Targeted Oral Health Text Messaging for Underserved Children Attending Pediatric Clinics: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jan 2;8(1):e2452780. doi: 10.1001/jamanetworkopen.2024.52780.

  PMID: 39745701 DERIVED

MeSH Terms

Conditions

Dental Caries; Health Behavior

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Behavior

Limitations and Caveats

Due to the COVID-19 pandemic, on March 12, 2020 Boston University Medical campus and Boston Medical Center IRB declared an immediate halt of in-person research activities. This resulted in a less than expected number of children attending the 12 and/or the 24 month oral health assessments.

Results Point of Contact

• Title: Belinda Borrelli, PhD
• Organization: Boston University Henry M. Goldman School of Dental Medicine

belindab@bu.edu

617-358-3358

Study Officials

• Belinda Borrelli, PhD

  Henry M. Goldman School of Dental Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Outcome Assessors and Oral Health Examiners will be blind to treatment condition.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: September 27, 2017
• Study Start: March 9, 2018
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: October 24, 2023
• Results First Posted: May 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)