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

Primary Purpose

Caries, Dental, Health Behavior

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OHT Parent targeted text messages
CWT Parent targeted text messages
Sponsored by
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Caries, Dental focused on measuring 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

Eligibility Criteria

0 Months - 7 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Boston Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oral health text messages (OHT)

Child wellness text messages (CWT)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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)
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)
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).
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).
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).

Secondary Outcome Measures

Text Message Program Length Satisfaction
One item adapted from the Mobile App Rating Scale (MARS) to measure parent/caregiver participants satisfaction with the duration of the text message program.
Parents' Perceived Impact of iSmile
Three items adapted from the MARS to measure the perceived impact of the OHT text message program on parent/caregiver participants' attitudes towards their child's oral health (range 1 - 7; higher scores mean a better outcome).
Child Preventive Dental Visits
One item adapted from the Basic Research Factors Questionnaire (BRFQ) to assess the number of parent/caregiver participants who indicated that their child had a preventive dental visit.
Fluoridated Toothpaste Use
One item derived from the Basic Research Factors Questionnaire (BRFQ) to measure whether parent/caregiver participants use toothpaste containing fluoride when brushing their child's teeth.
Perceived Impact of OHT Program on Parental Awareness
One item adapted from the Basic Research Factors Questionnaire (BRFQ) to measure parent/caregiver participants' (in the OHT arm) awareness of their child oral health.
Child Diet - Food Frequency
Parent/caregiver participants completed a food frequency questionnaire (FFQ) to assess their child's diet. Food/beverages items in the FFQ are categorized into groups according to the degree to which they promote dental caries, and a weighted estimated cariogenicity score (ECS) is computed (minimum and maximum scores range 0 - 3.80; higher scores mean a worse outcome).
Child Diet - Beverage Intake
Parent/caregiver participants completed the beverage questionnaire for preschoolers (BEVQ-PS) to assess their child's beverage intake. For each beverage item, the frequency and the amount of consumption are computed as average fluid ounces per day, and a composite score is computed for sugar sweetened beverages (including 100% fruit juice) consumption and then categorized into higher consumption (vs lower).
Child Tooth Brushing
An investigator-developed composite measure derived from the number of days and number of times parent/caregiver participants brushed or supervised brushing their child's teeth during a week (range: 0 - 21; higher scores mean a better outcome).
Parent/Caregiver Tooth Brushing
An investigator-developed composite measure derived from the number of days and number of times parent/caregiver participants brushed their teeth during a week (range: 0 - 21; higher scores mean a better outcome).
Child Oral Health-related Quality of Life
The Early Childhood Oral Health Impact Scale (ECOHIS) to measure parent/caregiver participants' perceptions of their child's oral health (range 0 - 16; higher scores mean a worse outcome).
Satisfaction With Text Message Program Features
One item adapted from the Mobile App Rating Scale (MARS) to measure parent/caregiver participants' overall level of satisfaction with the text message program features (range 1 - 7; higher scores mean a better outcome).
Child Toothbrushing (Clinical Guidelines)
An investigator-developed measure derived from the number of days and number of times parent/caregiver participants brushed or supervised brushing their child's teeth during a week recoded into "child met clinical guidelines for brushing" (brushing at least two times per day, seven days of the week) vs not.
Parents/Caregivers Toothbrushing (Clinical Guidelines)
An investigator-developed measure derived from the number of days and number of times parent/caregiver participants brushed their teeth during a week recoded into "parent/caregiver participants met clinical guidelines for brushing" (brushed at least two times per day, seven days of the week) vs not.
Diffusion of Text Messages (Satisfaction)
One item adapted from the Mobile App Rating Scale (MARS) asks parent/caregiver participants whether they showed (or forwarded) text messages to anyone else
Text Message Program Star Rating
One item adapted from the Mobile App Rating Scale (MARS) asks participants to give a star rating of the text message program. The star rating score range 1 star to 5 stars; a higher number of stars mean a better outcome.
Text Message Program Quality
Parent/caregiver participants responded to an investigator developed survey to measure several aspects of text messages quality (range 1 - 7; higher scores mean a better outcome).

Full Information

First Posted
September 21, 2017
Last Updated
October 19, 2023
Sponsor
Boston University
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
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1. Study Identification

Unique Protocol Identification Number
NCT03294590
Brief Title
Interactive Parent-Targeted Text Messaging in Pediatric Clinics to Reduce Caries Among Urban Children
Acronym
iSmile
Official Title
Randomized Controlled Trial of Interactive Parent-Targeted Text Messaging in Pediatric Clinics to Reduce Caries Among Urban Children
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 9, 2018 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
February 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Masking Description
Outcome Assessors and Oral Health Examiners will be blind to treatment condition.
Allocation
Randomized
Enrollment
754 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral health text messages (OHT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Child wellness text messages (CWT)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
OHT Parent targeted text messages
Intervention Description
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
Intervention Name(s)
CWT Parent targeted text messages
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dental Caries Increment
Description
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).
Time Frame
24-month time point (oral assessment)
Title
Parent/Caregiver Confidence to Brush
Description
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)
Time Frame
4-month time point (survey)
Title
Parent/Caregiver Motivation to Perform Oral Health Behaviors
Description
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)
Time Frame
4-month time point (survey)
Title
Parent/Caregiver Outcome Expectations for Oral Health Behaviors
Description
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).
Time Frame
4-month time point (survey)
Title
Self-efficacy to Perform Oral Health Behaviors
Description
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).
Time Frame
4-month time point (survey)
Title
Dental Caries Increment (Surface Level)
Description
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).
Time Frame
24-month time point (oral assessment)
Secondary Outcome Measure Information:
Title
Text Message Program Length Satisfaction
Description
One item adapted from the Mobile App Rating Scale (MARS) to measure parent/caregiver participants satisfaction with the duration of the text message program.
Time Frame
4-month time point (survey)
Title
Parents' Perceived Impact of iSmile
Description
Three items adapted from the MARS to measure the perceived impact of the OHT text message program on parent/caregiver participants' attitudes towards their child's oral health (range 1 - 7; higher scores mean a better outcome).
Time Frame
4-month time point (survey)
Title
Child Preventive Dental Visits
Description
One item adapted from the Basic Research Factors Questionnaire (BRFQ) to assess the number of parent/caregiver participants who indicated that their child had a preventive dental visit.
Time Frame
4-month, 12-month, and 24-month time points (survey)
Title
Fluoridated Toothpaste Use
Description
One item derived from the Basic Research Factors Questionnaire (BRFQ) to measure whether parent/caregiver participants use toothpaste containing fluoride when brushing their child's teeth.
Time Frame
4-month, 12-month, and 24-month time points (survey)
Title
Perceived Impact of OHT Program on Parental Awareness
Description
One item adapted from the Basic Research Factors Questionnaire (BRFQ) to measure parent/caregiver participants' (in the OHT arm) awareness of their child oral health.
Time Frame
24-month (survey)
Title
Child Diet - Food Frequency
Description
Parent/caregiver participants completed a food frequency questionnaire (FFQ) to assess their child's diet. Food/beverages items in the FFQ are categorized into groups according to the degree to which they promote dental caries, and a weighted estimated cariogenicity score (ECS) is computed (minimum and maximum scores range 0 - 3.80; higher scores mean a worse outcome).
Time Frame
4-month, 12-month, and 24-month time points (survey)
Title
Child Diet - Beverage Intake
Description
Parent/caregiver participants completed the beverage questionnaire for preschoolers (BEVQ-PS) to assess their child's beverage intake. For each beverage item, the frequency and the amount of consumption are computed as average fluid ounces per day, and a composite score is computed for sugar sweetened beverages (including 100% fruit juice) consumption and then categorized into higher consumption (vs lower).
Time Frame
4-month, 12-month, and 24-month time points (survey)
Title
Child Tooth Brushing
Description
An investigator-developed composite measure derived from the number of days and number of times parent/caregiver participants brushed or supervised brushing their child's teeth during a week (range: 0 - 21; higher scores mean a better outcome).
Time Frame
4-month, 12-month, and 24-month time points (survey)
Title
Parent/Caregiver Tooth Brushing
Description
An investigator-developed composite measure derived from the number of days and number of times parent/caregiver participants brushed their teeth during a week (range: 0 - 21; higher scores mean a better outcome).
Time Frame
4-month, 12-month, and 24-month time points (survey)
Title
Child Oral Health-related Quality of Life
Description
The Early Childhood Oral Health Impact Scale (ECOHIS) to measure parent/caregiver participants' perceptions of their child's oral health (range 0 - 16; higher scores mean a worse outcome).
Time Frame
4-month, 12-month, and 24-month time points (survey)
Title
Satisfaction With Text Message Program Features
Description
One item adapted from the Mobile App Rating Scale (MARS) to measure parent/caregiver participants' overall level of satisfaction with the text message program features (range 1 - 7; higher scores mean a better outcome).
Time Frame
4-month time point (survey)
Title
Child Toothbrushing (Clinical Guidelines)
Description
An investigator-developed measure derived from the number of days and number of times parent/caregiver participants brushed or supervised brushing their child's teeth during a week recoded into "child met clinical guidelines for brushing" (brushing at least two times per day, seven days of the week) vs not.
Time Frame
4-month, 12-month, and 24-month time points (survey)
Title
Parents/Caregivers Toothbrushing (Clinical Guidelines)
Description
An investigator-developed measure derived from the number of days and number of times parent/caregiver participants brushed their teeth during a week recoded into "parent/caregiver participants met clinical guidelines for brushing" (brushed at least two times per day, seven days of the week) vs not.
Time Frame
4-month, 12-month, and 24-month time points (survey)
Title
Diffusion of Text Messages (Satisfaction)
Description
One item adapted from the Mobile App Rating Scale (MARS) asks parent/caregiver participants whether they showed (or forwarded) text messages to anyone else
Time Frame
4-month time point (survey)
Title
Text Message Program Star Rating
Description
One item adapted from the Mobile App Rating Scale (MARS) asks participants to give a star rating of the text message program. The star rating score range 1 star to 5 stars; a higher number of stars mean a better outcome.
Time Frame
4-month time point (survey)
Title
Text Message Program Quality
Description
Parent/caregiver participants responded to an investigator developed survey to measure several aspects of text messages quality (range 1 - 7; higher scores mean a better outcome).
Time Frame
4-month time point (survey)
Other Pre-specified Outcome Measures:
Title
Type of Beverage Consumed Between Meals
Description
Parent/caregiver participants are asked to indicate what beverage their child consumes most often between meals.
Time Frame
4-month, 12-month, and 24-month time points (survey)
Title
Challenge Week During the OHT Text Message Program
Description
We assessed the number of parent/caregiver participants in the OHT arm who agreed to do the challenge (setting the goal of brushing their child's teeth every day, twice per day) that occurred within the 4-month text message program.
Time Frame
4-month time point
Title
Dental Caries (Per Subject)
Description
Number of primary teeth with new dental caries per child
Time Frame
24-Month (oral health assessment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Months
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Caregiver and child must meet all of the following: 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. Exclusion Criteria: If the caregiver or child meets any of the following criteria, the dyad will be excluded from participation in this study 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Belinda Borrelli, PhD
Organizational Affiliation
Henry M. Goldman School of Dental Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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