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

Randomized Controlled Trial of Interactive Parent-Targeted Text Messaging in Pediatric Clinics to Reduce Caries Among Urban Children

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03294590
Acronym
iSmile
Enrollment
754
Registered
2017-09-27
Start date
2018-03-09
Completion date
2022-02-28
Last updated
2023-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

OTHEROHT 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.

OTHERCWT 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.

Sponsors

National Institute of Dental and Craniofacial Research (NIDCR)
CollaboratorNIH
Boston University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Masking description

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

Eligibility

Sex/Gender
ALL
Age
0 Months to 7 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Self-efficacy to Perform Oral Health Behaviors4-month time point (survey)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)24-month time point (oral assessment)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).
Parent/Caregiver Outcome Expectations for Oral Health Behaviors4-month time point (survey)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).
Dental Caries Increment24-month time point (oral assessment)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 Brush4-month time point (survey)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 Behaviors4-month time point (survey)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)

Secondary

MeasureTime frameDescription
Child Diet - Food Frequency4-month, 12-month, and 24-month time points (survey)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 Intake4-month, 12-month, and 24-month time points (survey)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 Brushing4-month, 12-month, and 24-month time points (survey)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 Brushing4-month, 12-month, and 24-month time points (survey)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).
Satisfaction With Text Message Program Features4-month time point (survey)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)4-month, 12-month, and 24-month time points (survey)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)4-month, 12-month, and 24-month time points (survey)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)4-month time point (survey)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 Rating4-month time point (survey)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 Quality4-month time point (survey)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).
Child Oral Health-related Quality of Life4-month, 12-month, and 24-month time points (survey)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).
Text Message Program Length Satisfaction4-month time point (survey)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 iSmile4-month time point (survey)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 Visits4-month, 12-month, and 24-month time points (survey)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 Use4-month, 12-month, and 24-month time points (survey)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 Awareness24-month (survey)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.

Other

MeasureTime frameDescription
Type of Beverage Consumed Between Meals4-month, 12-month, and 24-month time points (survey)Parent/caregiver participants are asked to indicate what beverage their child consumes most often between meals.
Dental Caries (Per Subject)24-Month (oral health assessment)Number of primary teeth with new dental caries per child
Challenge Week During the OHT Text Message Program4-month time pointWe 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.

Countries

United States

Participant flow

Pre-assignment details

754 dyads (parents or caregivers and child) were enrolled and randomized.

Participants by arm

ArmCount
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. 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.
754
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. 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.
754
Total1,508

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up105107

Baseline characteristics

CharacteristicOral Health Text Messages (OHT)Child Wellness Text Messages (CWT)Total
Age, Continuous
Children participants
2.9 years
STANDARD_DEVIATION 1.7
2.8 years
STANDARD_DEVIATION 1.6
2.9 years
STANDARD_DEVIATION 1.7
Age, Continuous
Parent/caregiver participants
32.8 years
STANDARD_DEVIATION 7
33.0 years
STANDARD_DEVIATION 7.4
32.9 years
STANDARD_DEVIATION 7.2
Ethnicity (NIH/OMB)
Children participants
Hispanic or Latino
114 Participants113 Participants227 Participants
Ethnicity (NIH/OMB)
Children participants
Not Hispanic or Latino
252 Participants251 Participants503 Participants
Ethnicity (NIH/OMB)
Children participants
Unknown or Not Reported
11 Participants13 Participants24 Participants
Ethnicity (NIH/OMB)
Parent/caregiver participants
Hispanic or Latino
98 Participants96 Participants194 Participants
Ethnicity (NIH/OMB)
Parent/caregiver participants
Not Hispanic or Latino
270 Participants270 Participants540 Participants
Ethnicity (NIH/OMB)
Parent/caregiver participants
Unknown or Not Reported
9 Participants11 Participants20 Participants
Race (NIH/OMB)
Children participants
American Indian or Alaska Native
2 Participants1 Participants3 Participants
Race (NIH/OMB)
Children participants
Asian
6 Participants4 Participants10 Participants
Race (NIH/OMB)
Children participants
Black or African American
225 Participants199 Participants424 Participants
Race (NIH/OMB)
Children participants
More than one race
58 Participants72 Participants130 Participants
Race (NIH/OMB)
Children participants
Native Hawaiian or Other Pacific Islander
1 Participants1 Participants2 Participants
Race (NIH/OMB)
Children participants
Unknown or Not Reported
52 Participants59 Participants111 Participants
Race (NIH/OMB)
Children participants
White
33 Participants41 Participants74 Participants
Race (NIH/OMB)
Parent/caregiver participants
American Indian or Alaska Native
2 Participants1 Participants3 Participants
Race (NIH/OMB)
Parent/caregiver participants
Asian
7 Participants9 Participants16 Participants
Race (NIH/OMB)
Parent/caregiver participants
Black or African American
235 Participants205 Participants440 Participants
Race (NIH/OMB)
Parent/caregiver participants
More than one race
25 Participants39 Participants64 Participants
Race (NIH/OMB)
Parent/caregiver participants
Native Hawaiian or Other Pacific Islander
1 Participants2 Participants3 Participants
Race (NIH/OMB)
Parent/caregiver participants
Unknown or Not Reported
61 Participants73 Participants134 Participants
Race (NIH/OMB)
Parent/caregiver participants
White
46 Participants48 Participants94 Participants
Region of Enrollment
United States
754 participants754 participants1508 participants
Sex: Female, Male
Children participants
Female
186 Participants191 Participants377 Participants
Sex: Female, Male
Children participants
Male
191 Participants186 Participants377 Participants
Sex: Female, Male
Parent/caregiver participants
Female
358 Participants355 Participants713 Participants
Sex: Female, Male
Parent/caregiver participants
Male
19 Participants22 Participants41 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 3770 / 377
other
Total, other adverse events
0 / 3770 / 377
serious
Total, serious adverse events
1 / 3770 / 377

Outcome results

Primary

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).

Time frame: 24-month time point (oral assessment)

Population: Number of children with any new dental caries in primary teeth (using multiple imputation methods to account for missing oral health assessment data at 24-month)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Oral Health Text Messages (OHT)Dental Caries Increment162 Participants
Child Wellness Text Messages (CWT)Dental Caries Increment161 Participants
Primary

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).

Time frame: 24-month time point (oral assessment)

Population: Number of tooth surfaces with new caries in children participants

ArmMeasureValue (COUNT_OF_UNITS)
Oral Health Text Messages (OHT)Dental Caries Increment (Surface Level)545 Tooth surfaces
Child Wellness Text Messages (CWT)Dental Caries Increment (Surface Level)496 Tooth surfaces
Primary

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)

Time frame: 4-month time point (survey)

Population: Scores on a self-efficacy measure (range 1 - 4; higher scores mean better outcome)

ArmMeasureValue (MEAN)Dispersion
Oral Health Text Messages (OHT)Parent/Caregiver Confidence to Brush2.9 score on a scaleStandard Deviation 1.2
Child Wellness Text Messages (CWT)Parent/Caregiver Confidence to Brush2.8 score on a scaleStandard Deviation 1.2
Primary

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)

Time frame: 4-month time point (survey)

Population: Scores on a motivation measure (range 1 - 7; higher scores mean better outcome)

ArmMeasureValue (MEAN)Dispersion
Oral Health Text Messages (OHT)Parent/Caregiver Motivation to Perform Oral Health Behaviors6.2 score on a scaleStandard Deviation 1.2
Child Wellness Text Messages (CWT)Parent/Caregiver Motivation to Perform Oral Health Behaviors6.0 score on a scaleStandard Deviation 1.3
Primary

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).

Time frame: 4-month time point (survey)

Population: Scores on an outcome expectancies measure (range 1 - 4; higher scores mean better outcome)

ArmMeasureValue (MEAN)Dispersion
Oral Health Text Messages (OHT)Parent/Caregiver Outcome Expectations for Oral Health Behaviors3.69 score on a scaleStandard Deviation 0.67
Child Wellness Text Messages (CWT)Parent/Caregiver Outcome Expectations for Oral Health Behaviors3.68 score on a scaleStandard Deviation 0.6
Primary

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).

Time frame: 4-month time point (survey)

Population: Scores on a confidence (self-efficacy) measure (range 1 - 7; higher scores mean better outcome)

ArmMeasureValue (MEAN)Dispersion
Oral Health Text Messages (OHT)Self-efficacy to Perform Oral Health Behaviors6.3 score on a scaleStandard Deviation 1.1
Child Wellness Text Messages (CWT)Self-efficacy to Perform Oral Health Behaviors6.2 score on a scaleStandard Deviation 1.2
Secondary

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).

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

Population: Number of parent/caregiver participants indicating that their child consumed higher sugar sweetened beverages including 100% fruit juice (=more than 4.5 fluid ounces per day).

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Oral Health Text Messages (OHT)Child Diet - Beverage Intake24-month125 Participants
Oral Health Text Messages (OHT)Child Diet - Beverage Intake12-month145 Participants
Oral Health Text Messages (OHT)Child Diet - Beverage Intake4-month128 Participants
Child Wellness Text Messages (CWT)Child Diet - Beverage Intake24-month142 Participants
Child Wellness Text Messages (CWT)Child Diet - Beverage Intake12-month131 Participants
Child Wellness Text Messages (CWT)Child Diet - Beverage Intake4-month141 Participants
Secondary

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).

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

Population: The estimated cariogenic score derived from a food frequency questionnaire (higher scores mean a worse outcome).

ArmMeasureGroupValue (MEAN)Dispersion
Oral Health Text Messages (OHT)Child Diet - Food Frequency24-month2.22 score on a scaleStandard Deviation 0.31
Oral Health Text Messages (OHT)Child Diet - Food Frequency12-month2.23 score on a scaleStandard Deviation 0.3
Oral Health Text Messages (OHT)Child Diet - Food Frequency4-month2.18 score on a scaleStandard Deviation 0.28
Child Wellness Text Messages (CWT)Child Diet - Food Frequency24-month2.27 score on a scaleStandard Deviation 0.27
Child Wellness Text Messages (CWT)Child Diet - Food Frequency12-month2.23 score on a scaleStandard Deviation 0.24
Child Wellness Text Messages (CWT)Child Diet - Food Frequency4-month2.22 score on a scaleStandard Deviation 0.24
Secondary

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).

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

Population: The Early Childhood Oral Health 'Family' Impact scale score (range 0 - 16; higher scores mean a worse outcome)

ArmMeasureGroupValue (MEAN)Dispersion
Oral Health Text Messages (OHT)Child Oral Health-related Quality of Life24-month1.03 score on a scaleStandard Deviation 2
Oral Health Text Messages (OHT)Child Oral Health-related Quality of Life12-month1.14 score on a scaleStandard Deviation 2.03
Oral Health Text Messages (OHT)Child Oral Health-related Quality of Life4-month0.65 score on a scaleStandard Deviation 1.55
Child Wellness Text Messages (CWT)Child Oral Health-related Quality of Life24-month0.99 score on a scaleStandard Deviation 1.8
Child Wellness Text Messages (CWT)Child Oral Health-related Quality of Life12-month0.96 score on a scaleStandard Deviation 1.79
Child Wellness Text Messages (CWT)Child Oral Health-related Quality of Life4-month0.80 score on a scaleStandard Deviation 1.76
Secondary

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.

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

Population: Number of parent/caregiver participants who indicated that their child had a preventive dental visit.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Oral Health Text Messages (OHT)Child Preventive Dental Visits24-month207 Participants
Oral Health Text Messages (OHT)Child Preventive Dental Visits12-month180 Participants
Oral Health Text Messages (OHT)Child Preventive Dental Visits4-month162 Participants
Child Wellness Text Messages (CWT)Child Preventive Dental Visits24-month181 Participants
Child Wellness Text Messages (CWT)Child Preventive Dental Visits12-month157 Participants
Child Wellness Text Messages (CWT)Child Preventive Dental Visits4-month131 Participants
Secondary

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).

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

Population: Number of child tooth brushings per week (range: 0 - 21; higher scores mean a better outcome)

ArmMeasureGroupValue (MEAN)Dispersion
Oral Health Text Messages (OHT)Child Tooth Brushing24-month12.0 units on a scaleStandard Deviation 4.5
Oral Health Text Messages (OHT)Child Tooth Brushing12-month12.0 units on a scaleStandard Deviation 4.4
Oral Health Text Messages (OHT)Child Tooth Brushing4-month12.9 units on a scaleStandard Deviation 3.7
Child Wellness Text Messages (CWT)Child Tooth Brushing24-month11.1 units on a scaleStandard Deviation 5.1
Child Wellness Text Messages (CWT)Child Tooth Brushing12-month11.6 units on a scaleStandard Deviation 4.6
Child Wellness Text Messages (CWT)Child Tooth Brushing4-month11.3 units on a scaleStandard Deviation 5
Secondary

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.

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

Population: Number of parent/caregiver participants who indicated that they brushed or supervised brushing their child's teeth at least two times per day, seven days of the week.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Oral Health Text Messages (OHT)Child Toothbrushing (Clinical Guidelines)24-Month177 Participants
Oral Health Text Messages (OHT)Child Toothbrushing (Clinical Guidelines)12-Month167 Participants
Oral Health Text Messages (OHT)Child Toothbrushing (Clinical Guidelines)4-Month214 Participants
Child Wellness Text Messages (CWT)Child Toothbrushing (Clinical Guidelines)24-Month147 Participants
Child Wellness Text Messages (CWT)Child Toothbrushing (Clinical Guidelines)12-Month160 Participants
Child Wellness Text Messages (CWT)Child Toothbrushing (Clinical Guidelines)4-Month156 Participants
Secondary

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

Time frame: 4-month time point (survey)

Population: The iSmile study consisted of oral health text messages for parent/caregiver participants in the OHT arm, and child wellness text messages for parent/caregiver participants in the CWT arm. Diffusion of text messages assessed the number of parents/caregivers who showed (or forwarded) text messages to others.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Oral Health Text Messages (OHT)Diffusion of Text Messages (Satisfaction)168 Participants
Child Wellness Text Messages (CWT)Diffusion of Text Messages (Satisfaction)177 Participants
Secondary

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.

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

Population: Number of parent/caregiver participants indicating use of fluoridated toothpaste to brush their child's teeth.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Oral Health Text Messages (OHT)Fluoridated Toothpaste Use24-month225 Participants
Oral Health Text Messages (OHT)Fluoridated Toothpaste Use12-month229 Participants
Oral Health Text Messages (OHT)Fluoridated Toothpaste Use4-month225 Participants
Child Wellness Text Messages (CWT)Fluoridated Toothpaste Use24-month207 Participants
Child Wellness Text Messages (CWT)Fluoridated Toothpaste Use12-month215 Participants
Child Wellness Text Messages (CWT)Fluoridated Toothpaste Use4-month210 Participants
Secondary

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).

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

Population: Number of parent/caregiver participants tooth brushings per week (range: 0 - 21; higher scores mean a better outcome).

ArmMeasureGroupValue (MEAN)Dispersion
Oral Health Text Messages (OHT)Parent/Caregiver Tooth Brushing24-month12.7 units on a scaleStandard Deviation 3.8
Oral Health Text Messages (OHT)Parent/Caregiver Tooth Brushing12-month12.7 units on a scaleStandard Deviation 4.2
Oral Health Text Messages (OHT)Parent/Caregiver Tooth Brushing4-month13.1 units on a scaleStandard Deviation 3.8
Child Wellness Text Messages (CWT)Parent/Caregiver Tooth Brushing24-month12.3 units on a scaleStandard Deviation 4.5
Child Wellness Text Messages (CWT)Parent/Caregiver Tooth Brushing12-month12.5 units on a scaleStandard Deviation 4.4
Child Wellness Text Messages (CWT)Parent/Caregiver Tooth Brushing4-month12.4 units on a scaleStandard Deviation 4.2
Secondary

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.

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

Population: Number of parent/caregiver participants who indicated that they brushed their teeth at least two times per day, seven days of the week.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Oral Health Text Messages (OHT)Parents/Caregivers Toothbrushing (Clinical Guidelines)24-Month188 Participants
Oral Health Text Messages (OHT)Parents/Caregivers Toothbrushing (Clinical Guidelines)12-Month195 Participants
Oral Health Text Messages (OHT)Parents/Caregivers Toothbrushing (Clinical Guidelines)4-Month208 Participants
Child Wellness Text Messages (CWT)Parents/Caregivers Toothbrushing (Clinical Guidelines)24-Month175 Participants
Child Wellness Text Messages (CWT)Parents/Caregivers Toothbrushing (Clinical Guidelines)12-Month183 Participants
Child Wellness Text Messages (CWT)Parents/Caregivers Toothbrushing (Clinical Guidelines)4-Month191 Participants
Secondary

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).

Time frame: 4-month time point (survey)

Population: Parent/caregiver participants in the OHT arm responded to How much do you think iSmile had a positive impact on?.. (1='not at all' to 7='very much'; higher scores mean a better outcome)

ArmMeasureGroupValue (MEAN)Dispersion
Oral Health Text Messages (OHT)Parents' Perceived Impact of iSmileMaking sure your child's teeth are brushed6.4 units on a scaleStandard Deviation 1.3
Oral Health Text Messages (OHT)Parents' Perceived Impact of iSmileDecreasing the amount of sugar-sweetened beverages your child drinks5.9 units on a scaleStandard Deviation 1.8
Oral Health Text Messages (OHT)Parents' Perceived Impact of iSmileYour feelings on taking your child to the dentist6.1 units on a scaleStandard Deviation 1.6
Secondary

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.

Time frame: 24-month (survey)

Population: Number of parent/caregiver participants in the OHT arm endorsing each response category in response to: iSmile has increased my awareness of my child's oral health (1='strongly disagree, to 5='strongly agree')

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Oral Health Text Messages (OHT)Perceived Impact of OHT Program on Parental Awareness1 - strongly disagree7 Participants
Oral Health Text Messages (OHT)Perceived Impact of OHT Program on Parental Awareness2 -3 Participants
Oral Health Text Messages (OHT)Perceived Impact of OHT Program on Parental Awareness3 -14 Participants
Oral Health Text Messages (OHT)Perceived Impact of OHT Program on Parental Awareness4 -33 Participants
Oral Health Text Messages (OHT)Perceived Impact of OHT Program on Parental Awareness5 - strongly agree207 Participants
Oral Health Text Messages (OHT)Perceived Impact of OHT Program on Parental Awarenessprefer not to answer8 Participants
Secondary

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).

Time frame: 4-month time point (survey)

Population: Average level of satisfaction with text message program features (1='not satisfied at all', to 7='very much satisfied'; higher scores mean a better outcome)

ArmMeasureValue (MEAN)Dispersion
Oral Health Text Messages (OHT)Satisfaction With Text Message Program Features6.12 units on a scaleStandard Deviation 1.27
Child Wellness Text Messages (CWT)Satisfaction With Text Message Program Features6.04 units on a scaleStandard Deviation 1.35
Secondary

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.

Time frame: 4-month time point (survey)

Population: The iSmile study consisted of oral health text messages for parent/caregiver participants in the OHT arm, and child wellness text messages for parent/caregiver participants in the CWT arm. Text message program length satisfaction assessed the number of parent/caregiver participants who selected each response option to: You've been receiving the iSmile text messages for about four months. What do you think about the length of the program?

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Oral Health Text Messages (OHT)Text Message Program Length SatisfactionIt was just about right193 Participants
Oral Health Text Messages (OHT)Text Message Program Length SatisfactionThe program should last longer68 Participants
Oral Health Text Messages (OHT)Text Message Program Length SatisfactionThe program should be shorter29 Participants
Child Wellness Text Messages (CWT)Text Message Program Length SatisfactionIt was just about right172 Participants
Child Wellness Text Messages (CWT)Text Message Program Length SatisfactionThe program should last longer80 Participants
Child Wellness Text Messages (CWT)Text Message Program Length SatisfactionThe program should be shorter36 Participants
Secondary

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).

Time frame: 4-month time point (survey)

Population: Parent/caregiver participants were asked 6 questions assessing the quality of the text messages (TMs) received during the program. Ratings were given on a 1 to 7 scale (higher scores mean a better outcome).

ArmMeasureGroupValue (MEAN)Dispersion
Oral Health Text Messages (OHT)Text Message Program QualityRelevant to cultural background5.81 units on a scaleStandard Deviation 1.65
Oral Health Text Messages (OHT)Text Message Program QualityAge appropriate for child6.0 units on a scaleStandard Deviation 1.4
Oral Health Text Messages (OHT)Text Message Program QualityContent of TMs easy to understand6.5 units on a scaleStandard Deviation 1.1
Oral Health Text Messages (OHT)Text Message Program QualityEasy to integrate into day/routine6.2 units on a scaleStandard Deviation 1.2
Oral Health Text Messages (OHT)Text Message Program QualityLanguage appropriate6.5 units on a scaleStandard Deviation 1.1
Oral Health Text Messages (OHT)Text Message Program QualityRelevant for you and your child6.2 units on a scaleStandard Deviation 1.4
Child Wellness Text Messages (CWT)Text Message Program QualityLanguage appropriate6.5 units on a scaleStandard Deviation 1.1
Child Wellness Text Messages (CWT)Text Message Program QualityRelevant to cultural background5.56 units on a scaleStandard Deviation 1.71
Child Wellness Text Messages (CWT)Text Message Program QualityEasy to integrate into day/routine6.2 units on a scaleStandard Deviation 1.3
Child Wellness Text Messages (CWT)Text Message Program QualityAge appropriate for child6.0 units on a scaleStandard Deviation 1.4
Child Wellness Text Messages (CWT)Text Message Program QualityRelevant for you and your child6.2 units on a scaleStandard Deviation 1.4
Child Wellness Text Messages (CWT)Text Message Program QualityContent of TMs easy to understand6.6 units on a scaleStandard Deviation 1
Secondary

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.

Time frame: 4-month time point (survey)

Population: The iSmile study consisted of oral health text messages for parent/caregiver participants in the OHT arm, and child wellness text messages for parent/caregiver participants in the CWT arm. The text message program star rating assessed the number of parent/caregiver participants who rated the text message program between 1 star and 5 stars.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Oral Health Text Messages (OHT)Text Message Program Star Rating1 star1 Participants
Oral Health Text Messages (OHT)Text Message Program Star Rating2 stars12 Participants
Oral Health Text Messages (OHT)Text Message Program Star Rating3 stars43 Participants
Oral Health Text Messages (OHT)Text Message Program Star Rating4 stars89 Participants
Oral Health Text Messages (OHT)Text Message Program Star Rating5 stars145 Participants
Oral Health Text Messages (OHT)Text Message Program Star Ratingprefer not to answer0 Participants
Child Wellness Text Messages (CWT)Text Message Program Star Rating5 stars139 Participants
Child Wellness Text Messages (CWT)Text Message Program Star Rating1 star3 Participants
Child Wellness Text Messages (CWT)Text Message Program Star Rating4 stars88 Participants
Child Wellness Text Messages (CWT)Text Message Program Star Rating2 stars7 Participants
Child Wellness Text Messages (CWT)Text Message Program Star Ratingprefer not to answer1 Participants
Child Wellness Text Messages (CWT)Text Message Program Star Rating3 stars50 Participants
Other Pre-specified

Challenge Week During the OHT Text Message Program

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

Population: Number of parent/caregiver participants in the OHT arm who agreed to do the challenge.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Oral Health Text Messages (OHT)Challenge Week During the OHT Text Message ProgramChallenge one189 Participants
Oral Health Text Messages (OHT)Challenge Week During the OHT Text Message ProgramChallenge two157 Participants
Other Pre-specified

Dental Caries (Per Subject)

Number of primary teeth with new dental caries per child

Time frame: 24-Month (oral health assessment)

Population: Number of primary teeth with new dental caries per child

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Oral Health Text Messages (OHT)Dental Caries (Per Subject)1 tooth with new caries19 Participants
Oral Health Text Messages (OHT)Dental Caries (Per Subject)3 to 5 teeth with new caries22 Participants
Oral Health Text Messages (OHT)Dental Caries (Per Subject)2 teeth with new caries13 Participants
Oral Health Text Messages (OHT)Dental Caries (Per Subject)6 or more teeth with new caries15 Participants
Oral Health Text Messages (OHT)Dental Caries (Per Subject)0 teeth with new caries91 Participants
Child Wellness Text Messages (CWT)Dental Caries (Per Subject)6 or more teeth with new caries14 Participants
Child Wellness Text Messages (CWT)Dental Caries (Per Subject)0 teeth with new caries95 Participants
Child Wellness Text Messages (CWT)Dental Caries (Per Subject)1 tooth with new caries15 Participants
Child Wellness Text Messages (CWT)Dental Caries (Per Subject)2 teeth with new caries16 Participants
Child Wellness Text Messages (CWT)Dental Caries (Per Subject)3 to 5 teeth with new caries16 Participants
Other Pre-specified

Type of Beverage Consumed Between Meals

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)

Population: Number of parent/caregiver participants indicating that their child consumed the beverage between meals.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Oral Health Text Messages (OHT)Type of Beverage Consumed Between Meals24-Month6. Flavored milk4 Participants
Oral Health Text Messages (OHT)Type of Beverage Consumed Between Meals12-Month1. Cow's milk50 Participants
Oral Health Text Messages (OHT)Type of Beverage Consumed Between Meals24-Month1. Cow's milk31 Participants
Oral Health Text Messages (OHT)Type of Beverage Consumed Between Meals24-Month2. Juice or juice drinks63 Participants
Oral Health Text Messages (OHT)Type of Beverage Consumed Between Meals24-Month3. Diet soda pop or other sugar free beverages1 Participants
Oral Health Text Messages (OHT)Type of Beverage Consumed Between Meals24-Month4. Water164 Participants
Oral Health Text Messages (OHT)Type of Beverage Consumed Between Meals24-Month5. Regular soda pop or other sugared beverages1 Participants
Oral Health Text Messages (OHT)Type of Beverage Consumed Between Meals4-MonthPrefer not to answer4 Participants
Oral Health Text Messages (OHT)Type of Beverage Consumed Between Meals24-Month7. Other3 Participants
Oral Health Text Messages (OHT)Type of Beverage Consumed Between Meals24-MonthDo not know2 Participants
Oral Health Text Messages (OHT)Type of Beverage Consumed Between Meals24-MonthPrefer not to answer3 Participants
Oral Health Text Messages (OHT)Type of Beverage Consumed Between Meals12-Month2. Juice or juice drinks63 Participants
Oral Health Text Messages (OHT)Type of Beverage Consumed Between Meals12-Month3. Diet soda pop or other sugar free beverages1 Participants
Oral Health Text Messages (OHT)Type of Beverage Consumed Between Meals12-Month4. Water154 Participants
Oral Health Text Messages (OHT)Type of Beverage Consumed Between Meals12-Month5. Regular soda pop or other sugared beverages2 Participants
Oral Health Text Messages (OHT)Type of Beverage Consumed Between Meals12-Month6. Flavored milk4 Participants
Oral Health Text Messages (OHT)Type of Beverage Consumed Between Meals12-Month7. Other5 Participants
Oral Health Text Messages (OHT)Type of Beverage Consumed Between Meals12-MonthDo not know0 Participants
Oral Health Text Messages (OHT)Type of Beverage Consumed Between Meals12-MonthPrefer not to answer3 Participants
Oral Health Text Messages (OHT)Type of Beverage Consumed Between Meals4-Month1. Cow's milk48 Participants
Oral Health Text Messages (OHT)Type of Beverage Consumed Between Meals4-Month2. Juice or juice drinks63 Participants
Oral Health Text Messages (OHT)Type of Beverage Consumed Between Meals4-Month3. Diet soda pop or other sugar free beverages1 Participants
Oral Health Text Messages (OHT)Type of Beverage Consumed Between Meals4-Month4. Water159 Participants
Oral Health Text Messages (OHT)Type of Beverage Consumed Between Meals4-Month5. Regular soda pop or other sugared beverages3 Participants
Oral Health Text Messages (OHT)Type of Beverage Consumed Between Meals4-Month6. Flavored milk4 Participants
Oral Health Text Messages (OHT)Type of Beverage Consumed Between Meals4-Month7. Other6 Participants
Oral Health Text Messages (OHT)Type of Beverage Consumed Between Meals4-MonthDo not know2 Participants
Child Wellness Text Messages (CWT)Type of Beverage Consumed Between Meals12-Month4. Water166 Participants
Child Wellness Text Messages (CWT)Type of Beverage Consumed Between Meals4-Month6. Flavored milk3 Participants
Child Wellness Text Messages (CWT)Type of Beverage Consumed Between Meals4-Month3. Diet soda pop or other sugar free beverages4 Participants
Child Wellness Text Messages (CWT)Type of Beverage Consumed Between Meals24-Month1. Cow's milk31 Participants
Child Wellness Text Messages (CWT)Type of Beverage Consumed Between Meals12-Month6. Flavored milk4 Participants
Child Wellness Text Messages (CWT)Type of Beverage Consumed Between Meals24-Month2. Juice or juice drinks77 Participants
Child Wellness Text Messages (CWT)Type of Beverage Consumed Between Meals4-MonthDo not know1 Participants
Child Wellness Text Messages (CWT)Type of Beverage Consumed Between Meals24-Month3. Diet soda pop or other sugar free beverages0 Participants
Child Wellness Text Messages (CWT)Type of Beverage Consumed Between Meals12-Month7. Other1 Participants
Child Wellness Text Messages (CWT)Type of Beverage Consumed Between Meals24-Month4. Water149 Participants
Child Wellness Text Messages (CWT)Type of Beverage Consumed Between Meals4-Month4. Water147 Participants
Child Wellness Text Messages (CWT)Type of Beverage Consumed Between Meals24-Month5. Regular soda pop or other sugared beverages1 Participants
Child Wellness Text Messages (CWT)Type of Beverage Consumed Between Meals12-MonthDo not know1 Participants
Child Wellness Text Messages (CWT)Type of Beverage Consumed Between Meals24-Month6. Flavored milk4 Participants
Child Wellness Text Messages (CWT)Type of Beverage Consumed Between Meals4-Month7. Other7 Participants
Child Wellness Text Messages (CWT)Type of Beverage Consumed Between Meals24-Month7. Other2 Participants
Child Wellness Text Messages (CWT)Type of Beverage Consumed Between Meals12-MonthPrefer not to answer5 Participants
Child Wellness Text Messages (CWT)Type of Beverage Consumed Between Meals24-MonthDo not know1 Participants
Child Wellness Text Messages (CWT)Type of Beverage Consumed Between Meals4-Month5. Regular soda pop or other sugared beverages0 Participants
Child Wellness Text Messages (CWT)Type of Beverage Consumed Between Meals12-Month5. Regular soda pop or other sugared beverages1 Participants
Child Wellness Text Messages (CWT)Type of Beverage Consumed Between Meals24-MonthPrefer not to answer5 Participants
Child Wellness Text Messages (CWT)Type of Beverage Consumed Between Meals12-Month1. Cow's milk42 Participants
Child Wellness Text Messages (CWT)Type of Beverage Consumed Between Meals4-Month1. Cow's milk56 Participants
Child Wellness Text Messages (CWT)Type of Beverage Consumed Between Meals12-Month2. Juice or juice drinks70 Participants
Child Wellness Text Messages (CWT)Type of Beverage Consumed Between Meals4-MonthPrefer not to answer1 Participants
Child Wellness Text Messages (CWT)Type of Beverage Consumed Between Meals12-Month3. Diet soda pop or other sugar free beverages0 Participants
Child Wellness Text Messages (CWT)Type of Beverage Consumed Between Meals4-Month2. Juice or juice drinks69 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026