Clinical trial NCT03294590: Interactive Parent-Targeted Text Messaging in Pediatric Clinics to Reduce Caries Among Urban Children
Official title: Randomized Controlled Trial of Interactive Parent-Targeted Text Messaging in Pediatric Clinics to Reduce Caries Among Urban Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2017-09-27
Enrollment: 754
Sex: ALL
Minimum age (years): 0
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria: Caregiver and child must meet all of the following:

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: If the caregiver or child meets any of the following criteria, the dyad will be excluded from participation in this study

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.

Primary outcomes:
measure: Dental Caries Increment
timeFrame: 24-month time point (oral assessment)
measure: Parent/Caregiver Confidence to Brush
timeFrame: 4-month time point (survey)
measure: Parent/Caregiver Motivation to Perform Oral Health Behaviors
timeFrame: 4-month time point (survey)
measure: Parent/Caregiver Outcome Expectations for Oral Health Behaviors
timeFrame: 4-month time point (survey)
measure: Self-efficacy to Perform Oral Health Behaviors
timeFrame: 4-month time point (survey)
measure: Dental Caries Increment (Surface Level)
timeFrame: 24-month time point (oral assessment)
Secondary outcomes:
measure: Text Message Program Length Satisfaction
timeFrame: 4-month time point (survey)
measure: Parents' Perceived Impact of iSmile
timeFrame: 4-month time point (survey)
measure: Child Preventive Dental Visits
timeFrame: 4-month, 12-month, and 24-month time points (survey)
measure: Fluoridated Toothpaste Use
timeFrame: 4-month, 12-month, and 24-month time points (survey)
measure: Perceived Impact of OHT Program on Parental Awareness
timeFrame: 24-month (survey)
measure: Child Diet - Food Frequency
timeFrame: 4-month, 12-month, and 24-month time points (survey)
measure: Child Diet - Beverage Intake
timeFrame: 4-month, 12-month, and 24-month time points (survey)
measure: Child Tooth Brushing
timeFrame: 4-month, 12-month, and 24-month time points (survey)
measure: Parent/Caregiver Tooth Brushing
timeFrame: 4-month, 12-month, and 24-month time points (survey)
measure: Child Oral Health-related Quality of Life
timeFrame: 4-month, 12-month, and 24-month time points (survey)
measure: Satisfaction With Text Message Program Features
timeFrame: 4-month time point (survey)
measure: Child Toothbrushing (Clinical Guidelines)
timeFrame: 4-month, 12-month, and 24-month time points (survey)
measure: Parents/Caregivers Toothbrushing (Clinical Guidelines)
timeFrame: 4-month, 12-month, and 24-month time points (survey)
measure: Diffusion of Text Messages (Satisfaction)
timeFrame: 4-month time point (survey)
measure: Text Message Program Star Rating
timeFrame: 4-month time point (survey)
measure: Text Message Program Quality
timeFrame: 4-month time point (survey)
Other outcomes:
measure: Type of Beverage Consumed Between Meals
timeFrame: 4-month, 12-month, and 24-month time points (survey)
measure: Challenge Week During the OHT Text Message Program
timeFrame: 4-month time point
measure: Dental Caries (Per Subject)
timeFrame: 24-Month (oral health assessment)
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Henry M. Goldman School of Dental Medicine
name: Belinda Borrelli, PhD
role: PRINCIPAL_INVESTIGATOR
References: