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

NCT ID: NCT03294590

Last Updated: 2023-10-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

754 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-09

Study Completion Date

2022-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Caries, Dental Health Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors
Outcome Assessors and Oral Health Examiners will be blind to treatment condition.

Study Groups

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Oral health text messages (OHT)

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.

Group Type EXPERIMENTAL

OHT Parent targeted text messages

Intervention Type 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.

Child wellness text messages (CWT)

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.

Group Type ACTIVE_COMPARATOR

CWT Parent targeted text messages

Intervention Type 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.

Interventions

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OHT Parent targeted text messages

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.

Intervention Type OTHER

CWT Parent targeted text messages

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. 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
2. The child must receive medical care at one of the participating pediatric clinics.
3. Speak, understand, and read either English or Spanish
4. Have a mobile phone.

Exclusion Criteria

1. 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.
2. Children who cannot complete the baseline oral health exam.
Minimum Eligible Age

0 Months

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role collaborator

Boston University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Belinda Borrelli, PhD

Role: PRINCIPAL_INVESTIGATOR

Henry M. Goldman School of Dental Medicine

Locations

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Boston Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39745701 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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4UH3DE025492-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-36857

Identifier Type: -

Identifier Source: org_study_id

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