Trial Outcomes & Findings for Interactive Parent-Targeted Text Messaging in Pediatric Clinics to Reduce Caries Among Urban Children (NCT NCT03294590)
NCT ID: NCT03294590
Last Updated: 2023-10-24
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
754 participants
Primary outcome timeframe
24-month time point (oral assessment)
Results posted on
2023-10-24
Participant Flow
754 dyads (parents or caregivers and child) were enrolled and randomized.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
377
|
377
|
|
Overall Study
Number of Parent/Caregiver Participants
|
377
|
377
|
|
Overall Study
Number of Children Participants
|
377
|
377
|
|
Overall Study
4-month Time Point (Survey)
|
290
|
288
|
|
Overall Study
12-month Time Point (Survey)
|
282
|
290
|
|
Overall Study
12-month Time Point (Oral Exam)
|
206
|
185
|
|
Overall Study
24-month Time Point (Survey)
|
272
|
270
|
|
Overall Study
24-month Time Point (Oral Exam)
|
160
|
156
|
|
Overall Study
COMPLETED
|
272
|
270
|
|
Overall Study
NOT COMPLETED
|
105
|
107
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
105
|
107
|
Baseline Characteristics
754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
Baseline characteristics by cohort
| Measure |
Oral Health Text Messages (OHT)
n=754 Participants
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.
|
Child Wellness Text Messages (CWT)
n=754 Participants
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.
|
Total
n=1508 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Parent/caregiver participants
|
32.8 years
STANDARD_DEVIATION 7.0 • n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
33.0 years
STANDARD_DEVIATION 7.4 • n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
32.9 years
STANDARD_DEVIATION 7.2 • n=754 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
|
Age, Continuous
Children participants
|
2.9 years
STANDARD_DEVIATION 1.7 • n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
2.8 years
STANDARD_DEVIATION 1.6 • n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
2.9 years
STANDARD_DEVIATION 1.7 • n=754 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
|
Sex: Female, Male
Parent/caregiver participants · Female
|
358 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
355 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
713 Participants
n=754 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
|
Sex: Female, Male
Parent/caregiver participants · Male
|
19 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
22 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
41 Participants
n=754 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
|
Sex: Female, Male
Children participants · Female
|
186 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
191 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
377 Participants
n=754 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
|
Sex: Female, Male
Children participants · Male
|
191 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
186 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
377 Participants
n=754 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
|
Ethnicity (NIH/OMB)
Parent/caregiver participants · Hispanic or Latino
|
98 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
96 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
194 Participants
n=754 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
|
Ethnicity (NIH/OMB)
Parent/caregiver participants · Not Hispanic or Latino
|
270 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
270 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
540 Participants
n=754 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
|
Ethnicity (NIH/OMB)
Parent/caregiver participants · Unknown or Not Reported
|
9 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
11 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
20 Participants
n=754 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
|
Ethnicity (NIH/OMB)
Children participants · Hispanic or Latino
|
114 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
113 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
227 Participants
n=754 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
|
Ethnicity (NIH/OMB)
Children participants · Not Hispanic or Latino
|
252 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
251 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
503 Participants
n=754 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
|
Ethnicity (NIH/OMB)
Children participants · Unknown or Not Reported
|
11 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
13 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
24 Participants
n=754 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
|
Race (NIH/OMB)
Parent/caregiver participants · American Indian or Alaska Native
|
2 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
1 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
3 Participants
n=754 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
|
Race (NIH/OMB)
Parent/caregiver participants · Asian
|
7 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
9 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
16 Participants
n=754 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
|
Race (NIH/OMB)
Parent/caregiver participants · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
2 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
3 Participants
n=754 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
|
Race (NIH/OMB)
Parent/caregiver participants · Black or African American
|
235 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
205 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
440 Participants
n=754 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
|
Race (NIH/OMB)
Parent/caregiver participants · White
|
46 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
48 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
94 Participants
n=754 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
|
Race (NIH/OMB)
Parent/caregiver participants · More than one race
|
25 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
39 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
64 Participants
n=754 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
|
Race (NIH/OMB)
Parent/caregiver participants · Unknown or Not Reported
|
61 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
73 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
134 Participants
n=754 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
|
Race (NIH/OMB)
Children participants · American Indian or Alaska Native
|
2 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
1 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
3 Participants
n=754 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
|
Race (NIH/OMB)
Children participants · Asian
|
6 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
4 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
10 Participants
n=754 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
|
Race (NIH/OMB)
Children participants · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
1 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
2 Participants
n=754 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
|
Race (NIH/OMB)
Children participants · Black or African American
|
225 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
199 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
424 Participants
n=754 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
|
Race (NIH/OMB)
Children participants · White
|
33 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
41 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
74 Participants
n=754 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
|
Race (NIH/OMB)
Children participants · More than one race
|
58 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
72 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
130 Participants
n=754 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
|
Race (NIH/OMB)
Children participants · Unknown or Not Reported
|
52 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
59 Participants
n=377 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
111 Participants
n=754 Participants • 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
|
|
Region of Enrollment
United States
|
754 participants
n=754 Participants
|
754 participants
n=754 Participants
|
1508 participants
n=1508 Participants
|
PRIMARY outcome
Timeframe: 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)
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).
Outcome measures
| Measure |
Oral Health Text Messages (OHT)
n=377 Participants
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.
|
Child Wellness Text Messages (CWT)
n=377 Participants
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.
|
|---|---|---|
|
Dental Caries Increment
|
162 Participants
|
161 Participants
|
PRIMARY outcome
Timeframe: 4-month time point (survey)Population: Scores on a self-efficacy measure (range 1 - 4; higher scores mean better outcome)
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)
Outcome measures
| Measure |
Oral Health Text Messages (OHT)
n=290 Participants
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.
|
Child Wellness Text Messages (CWT)
n=288 Participants
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.
|
|---|---|---|
|
Parent/Caregiver Confidence to Brush
|
2.9 score on a scale
Standard Deviation 1.2
|
2.8 score on a scale
Standard Deviation 1.2
|
PRIMARY outcome
Timeframe: 4-month time point (survey)Population: Scores on a motivation measure (range 1 - 7; higher scores mean better outcome)
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)
Outcome measures
| Measure |
Oral Health Text Messages (OHT)
n=290 Participants
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.
|
Child Wellness Text Messages (CWT)
n=288 Participants
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.
|
|---|---|---|
|
Parent/Caregiver Motivation to Perform Oral Health Behaviors
|
6.2 score on a scale
Standard Deviation 1.2
|
6.0 score on a scale
Standard Deviation 1.3
|
PRIMARY outcome
Timeframe: 4-month time point (survey)Population: Scores on an outcome expectancies measure (range 1 - 4; higher scores mean better outcome)
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).
Outcome measures
| Measure |
Oral Health Text Messages (OHT)
n=290 Participants
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.
|
Child Wellness Text Messages (CWT)
n=288 Participants
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.
|
|---|---|---|
|
Parent/Caregiver Outcome Expectations for Oral Health Behaviors
|
3.69 score on a scale
Standard Deviation 0.67
|
3.68 score on a scale
Standard Deviation 0.60
|
PRIMARY outcome
Timeframe: 4-month time point (survey)Population: Scores on a confidence (self-efficacy) measure (range 1 - 7; higher scores mean better outcome)
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).
Outcome measures
| Measure |
Oral Health Text Messages (OHT)
n=290 Participants
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.
|
Child Wellness Text Messages (CWT)
n=288 Participants
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.
|
|---|---|---|
|
Self-efficacy to Perform Oral Health Behaviors
|
6.3 score on a scale
Standard Deviation 1.1
|
6.2 score on a scale
Standard Deviation 1.2
|
PRIMARY outcome
Timeframe: 24-month time point (oral assessment)Population: Number of tooth surfaces with new caries in children participants
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).
Outcome measures
| Measure |
Oral Health Text Messages (OHT)
n=13553 Tooth surfaces
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.
|
Child Wellness Text Messages (CWT)
n=13477 Tooth surfaces
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.
|
|---|---|---|
|
Dental Caries Increment (Surface Level)
|
545 Tooth surfaces
|
496 Tooth surfaces
|
SECONDARY outcome
Timeframe: 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?"
One item adapted from the Mobile App Rating Scale (MARS) to measure parent/caregiver participants satisfaction with the duration of the text message program.
Outcome measures
| Measure |
Oral Health Text Messages (OHT)
n=290 Participants
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.
|
Child Wellness Text Messages (CWT)
n=288 Participants
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.
|
|---|---|---|
|
Text Message Program Length Satisfaction
It was just about right
|
193 Participants
|
172 Participants
|
|
Text Message Program Length Satisfaction
The program should last longer
|
68 Participants
|
80 Participants
|
|
Text Message Program Length Satisfaction
The program should be shorter
|
29 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: 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)
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).
Outcome measures
| Measure |
Oral Health Text Messages (OHT)
n=290 Participants
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.
|
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.
|
|---|---|---|
|
Parents' Perceived Impact of iSmile
Making sure your child's teeth are brushed
|
6.4 units on a scale
Standard Deviation 1.3
|
—
|
|
Parents' Perceived Impact of iSmile
Decreasing the amount of sugar-sweetened beverages your child drinks
|
5.9 units on a scale
Standard Deviation 1.8
|
—
|
|
Parents' Perceived Impact of iSmile
Your feelings on taking your child to the dentist
|
6.1 units on a scale
Standard Deviation 1.6
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Oral Health Text Messages (OHT)
n=377 Participants
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.
|
Child Wellness Text Messages (CWT)
n=377 Participants
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.
|
|---|---|---|
|
Child Preventive Dental Visits
24-month
|
207 Participants
|
181 Participants
|
|
Child Preventive Dental Visits
12-month
|
180 Participants
|
157 Participants
|
|
Child Preventive Dental Visits
4-month
|
162 Participants
|
131 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Oral Health Text Messages (OHT)
n=377 Participants
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.
|
Child Wellness Text Messages (CWT)
n=377 Participants
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.
|
|---|---|---|
|
Fluoridated Toothpaste Use
24-month
|
225 Participants
|
207 Participants
|
|
Fluoridated Toothpaste Use
12-month
|
229 Participants
|
215 Participants
|
|
Fluoridated Toothpaste Use
4-month
|
225 Participants
|
210 Participants
|
SECONDARY outcome
Timeframe: 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')
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.
Outcome measures
| Measure |
Oral Health Text Messages (OHT)
n=272 Participants
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.
|
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.
|
|---|---|---|
|
Perceived Impact of OHT Program on Parental Awareness
1 - strongly disagree
|
7 Participants
|
—
|
|
Perceived Impact of OHT Program on Parental Awareness
2 -
|
3 Participants
|
—
|
|
Perceived Impact of OHT Program on Parental Awareness
3 -
|
14 Participants
|
—
|
|
Perceived Impact of OHT Program on Parental Awareness
4 -
|
33 Participants
|
—
|
|
Perceived Impact of OHT Program on Parental Awareness
5 - strongly agree
|
207 Participants
|
—
|
|
Perceived Impact of OHT Program on Parental Awareness
prefer not to answer
|
8 Participants
|
—
|
SECONDARY outcome
Timeframe: 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).
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).
Outcome measures
| Measure |
Oral Health Text Messages (OHT)
n=377 Participants
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.
|
Child Wellness Text Messages (CWT)
n=377 Participants
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.
|
|---|---|---|
|
Child Diet - Food Frequency
24-month
|
2.22 score on a scale
Standard Deviation 0.31
|
2.27 score on a scale
Standard Deviation 0.27
|
|
Child Diet - Food Frequency
12-month
|
2.23 score on a scale
Standard Deviation 0.30
|
2.23 score on a scale
Standard Deviation 0.24
|
|
Child Diet - Food Frequency
4-month
|
2.18 score on a scale
Standard Deviation 0.28
|
2.22 score on a scale
Standard Deviation 0.24
|
SECONDARY outcome
Timeframe: 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").
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).
Outcome measures
| Measure |
Oral Health Text Messages (OHT)
n=377 Participants
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.
|
Child Wellness Text Messages (CWT)
n=377 Participants
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.
|
|---|---|---|
|
Child Diet - Beverage Intake
24-month
|
125 Participants
|
142 Participants
|
|
Child Diet - Beverage Intake
12-month
|
145 Participants
|
131 Participants
|
|
Child Diet - Beverage Intake
4-month
|
128 Participants
|
141 Participants
|
SECONDARY outcome
Timeframe: 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)
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).
Outcome measures
| Measure |
Oral Health Text Messages (OHT)
n=377 Participants
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.
|
Child Wellness Text Messages (CWT)
n=377 Participants
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.
|
|---|---|---|
|
Child Tooth Brushing
24-month
|
12.0 units on a scale
Standard Deviation 4.5
|
11.1 units on a scale
Standard Deviation 5.1
|
|
Child Tooth Brushing
12-month
|
12.0 units on a scale
Standard Deviation 4.4
|
11.6 units on a scale
Standard Deviation 4.6
|
|
Child Tooth Brushing
4-month
|
12.9 units on a scale
Standard Deviation 3.7
|
11.3 units on a scale
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: 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).
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).
Outcome measures
| Measure |
Oral Health Text Messages (OHT)
n=377 Participants
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.
|
Child Wellness Text Messages (CWT)
n=377 Participants
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.
|
|---|---|---|
|
Parent/Caregiver Tooth Brushing
24-month
|
12.7 units on a scale
Standard Deviation 3.8
|
12.3 units on a scale
Standard Deviation 4.5
|
|
Parent/Caregiver Tooth Brushing
12-month
|
12.7 units on a scale
Standard Deviation 4.2
|
12.5 units on a scale
Standard Deviation 4.4
|
|
Parent/Caregiver Tooth Brushing
4-month
|
13.1 units on a scale
Standard Deviation 3.8
|
12.4 units on a scale
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: 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)
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).
Outcome measures
| Measure |
Oral Health Text Messages (OHT)
n=377 Participants
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.
|
Child Wellness Text Messages (CWT)
n=377 Participants
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.
|
|---|---|---|
|
Child Oral Health-related Quality of Life
24-month
|
1.03 score on a scale
Standard Deviation 2.00
|
0.99 score on a scale
Standard Deviation 1.80
|
|
Child Oral Health-related Quality of Life
12-month
|
1.14 score on a scale
Standard Deviation 2.03
|
0.96 score on a scale
Standard Deviation 1.79
|
|
Child Oral Health-related Quality of Life
4-month
|
0.65 score on a scale
Standard Deviation 1.55
|
0.80 score on a scale
Standard Deviation 1.76
|
SECONDARY outcome
Timeframe: 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)
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).
Outcome measures
| Measure |
Oral Health Text Messages (OHT)
n=290 Participants
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.
|
Child Wellness Text Messages (CWT)
n=288 Participants
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.
|
|---|---|---|
|
Satisfaction With Text Message Program Features
|
6.12 units on a scale
Standard Deviation 1.27
|
6.04 units on a scale
Standard Deviation 1.35
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Oral Health Text Messages (OHT)
n=377 Participants
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.
|
Child Wellness Text Messages (CWT)
n=377 Participants
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.
|
|---|---|---|
|
Child Toothbrushing (Clinical Guidelines)
24-Month
|
177 Participants
|
147 Participants
|
|
Child Toothbrushing (Clinical Guidelines)
12-Month
|
167 Participants
|
160 Participants
|
|
Child Toothbrushing (Clinical Guidelines)
4-Month
|
214 Participants
|
156 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Oral Health Text Messages (OHT)
n=377 Participants
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.
|
Child Wellness Text Messages (CWT)
n=377 Participants
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.
|
|---|---|---|
|
Parents/Caregivers Toothbrushing (Clinical Guidelines)
24-Month
|
188 Participants
|
175 Participants
|
|
Parents/Caregivers Toothbrushing (Clinical Guidelines)
12-Month
|
195 Participants
|
183 Participants
|
|
Parents/Caregivers Toothbrushing (Clinical Guidelines)
4-Month
|
208 Participants
|
191 Participants
|
SECONDARY outcome
Timeframe: 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.
One item adapted from the Mobile App Rating Scale (MARS) asks parent/caregiver participants whether they showed (or forwarded) text messages to anyone else
Outcome measures
| Measure |
Oral Health Text Messages (OHT)
n=290 Participants
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.
|
Child Wellness Text Messages (CWT)
n=288 Participants
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.
|
|---|---|---|
|
Diffusion of Text Messages (Satisfaction)
|
168 Participants
|
177 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Oral Health Text Messages (OHT)
n=290 Participants
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.
|
Child Wellness Text Messages (CWT)
n=288 Participants
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.
|
|---|---|---|
|
Text Message Program Star Rating
1 star
|
1 Participants
|
3 Participants
|
|
Text Message Program Star Rating
2 stars
|
12 Participants
|
7 Participants
|
|
Text Message Program Star Rating
3 stars
|
43 Participants
|
50 Participants
|
|
Text Message Program Star Rating
4 stars
|
89 Participants
|
88 Participants
|
|
Text Message Program Star Rating
5 stars
|
145 Participants
|
139 Participants
|
|
Text Message Program Star Rating
prefer not to answer
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 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).
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).
Outcome measures
| Measure |
Oral Health Text Messages (OHT)
n=290 Participants
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.
|
Child Wellness Text Messages (CWT)
n=288 Participants
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.
|
|---|---|---|
|
Text Message Program Quality
Relevant to cultural background
|
5.81 units on a scale
Standard Deviation 1.65
|
5.56 units on a scale
Standard Deviation 1.71
|
|
Text Message Program Quality
Age appropriate for child
|
6.0 units on a scale
Standard Deviation 1.4
|
6.0 units on a scale
Standard Deviation 1.4
|
|
Text Message Program Quality
Content of TMs easy to understand
|
6.5 units on a scale
Standard Deviation 1.1
|
6.6 units on a scale
Standard Deviation 1.0
|
|
Text Message Program Quality
Easy to integrate into day/routine
|
6.2 units on a scale
Standard Deviation 1.2
|
6.2 units on a scale
Standard Deviation 1.3
|
|
Text Message Program Quality
Language appropriate
|
6.5 units on a scale
Standard Deviation 1.1
|
6.5 units on a scale
Standard Deviation 1.1
|
|
Text Message Program Quality
Relevant for you and your child
|
6.2 units on a scale
Standard Deviation 1.4
|
6.2 units on a scale
Standard Deviation 1.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Parent/caregiver participants are asked to indicate what beverage their child consumes most often between meals.
Outcome measures
| Measure |
Oral Health Text Messages (OHT)
n=377 Participants
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.
|
Child Wellness Text Messages (CWT)
n=377 Participants
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.
|
|---|---|---|
|
Type of Beverage Consumed Between Meals
24-Month · 1. Cow's milk
|
31 Participants
|
31 Participants
|
|
Type of Beverage Consumed Between Meals
24-Month · 2. Juice or juice drinks
|
63 Participants
|
77 Participants
|
|
Type of Beverage Consumed Between Meals
24-Month · 3. Diet soda pop or other sugar free beverages
|
1 Participants
|
0 Participants
|
|
Type of Beverage Consumed Between Meals
24-Month · 4. Water
|
164 Participants
|
149 Participants
|
|
Type of Beverage Consumed Between Meals
24-Month · 5. Regular soda pop or other sugared beverages
|
1 Participants
|
1 Participants
|
|
Type of Beverage Consumed Between Meals
24-Month · 6. Flavored milk
|
4 Participants
|
4 Participants
|
|
Type of Beverage Consumed Between Meals
24-Month · 7. Other
|
3 Participants
|
2 Participants
|
|
Type of Beverage Consumed Between Meals
24-Month · Do not know
|
2 Participants
|
1 Participants
|
|
Type of Beverage Consumed Between Meals
24-Month · Prefer not to answer
|
3 Participants
|
5 Participants
|
|
Type of Beverage Consumed Between Meals
12-Month · 1. Cow's milk
|
50 Participants
|
42 Participants
|
|
Type of Beverage Consumed Between Meals
12-Month · 2. Juice or juice drinks
|
63 Participants
|
70 Participants
|
|
Type of Beverage Consumed Between Meals
12-Month · 3. Diet soda pop or other sugar free beverages
|
1 Participants
|
0 Participants
|
|
Type of Beverage Consumed Between Meals
12-Month · 4. Water
|
154 Participants
|
166 Participants
|
|
Type of Beverage Consumed Between Meals
12-Month · 5. Regular soda pop or other sugared beverages
|
2 Participants
|
1 Participants
|
|
Type of Beverage Consumed Between Meals
12-Month · 6. Flavored milk
|
4 Participants
|
4 Participants
|
|
Type of Beverage Consumed Between Meals
12-Month · 7. Other
|
5 Participants
|
1 Participants
|
|
Type of Beverage Consumed Between Meals
12-Month · Do not know
|
0 Participants
|
1 Participants
|
|
Type of Beverage Consumed Between Meals
12-Month · Prefer not to answer
|
3 Participants
|
5 Participants
|
|
Type of Beverage Consumed Between Meals
4-Month · 1. Cow's milk
|
48 Participants
|
56 Participants
|
|
Type of Beverage Consumed Between Meals
4-Month · 2. Juice or juice drinks
|
63 Participants
|
69 Participants
|
|
Type of Beverage Consumed Between Meals
4-Month · 3. Diet soda pop or other sugar free beverages
|
1 Participants
|
4 Participants
|
|
Type of Beverage Consumed Between Meals
4-Month · 4. Water
|
159 Participants
|
147 Participants
|
|
Type of Beverage Consumed Between Meals
4-Month · 5. Regular soda pop or other sugared beverages
|
3 Participants
|
0 Participants
|
|
Type of Beverage Consumed Between Meals
4-Month · 6. Flavored milk
|
4 Participants
|
3 Participants
|
|
Type of Beverage Consumed Between Meals
4-Month · 7. Other
|
6 Participants
|
7 Participants
|
|
Type of Beverage Consumed Between Meals
4-Month · Do not know
|
2 Participants
|
1 Participants
|
|
Type of Beverage Consumed Between Meals
4-Month · Prefer not to answer
|
4 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4-month time pointPopulation: Number of parent/caregiver participants in the OHT arm who agreed to do the challenge.
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.
Outcome measures
| Measure |
Oral Health Text Messages (OHT)
n=377 Participants
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.
|
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.
|
|---|---|---|
|
Challenge Week During the OHT Text Message Program
Challenge one
|
189 Participants
|
—
|
|
Challenge Week During the OHT Text Message Program
Challenge two
|
157 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24-Month (oral health assessment)Population: Number of primary teeth with new dental caries per child
Number of primary teeth with new dental caries per child
Outcome measures
| Measure |
Oral Health Text Messages (OHT)
n=160 Participants
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.
|
Child Wellness Text Messages (CWT)
n=156 Participants
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.
|
|---|---|---|
|
Dental Caries (Per Subject)
0 teeth with new caries
|
91 Participants
|
95 Participants
|
|
Dental Caries (Per Subject)
1 tooth with new caries
|
19 Participants
|
15 Participants
|
|
Dental Caries (Per Subject)
2 teeth with new caries
|
13 Participants
|
16 Participants
|
|
Dental Caries (Per Subject)
3 to 5 teeth with new caries
|
22 Participants
|
16 Participants
|
|
Dental Caries (Per Subject)
6 or more teeth with new caries
|
15 Participants
|
14 Participants
|
Adverse Events
Oral Health Text Messages (OHT)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Child Wellness Text Messages (CWT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oral Health Text Messages (OHT)
n=377 participants at risk
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.
|
Child Wellness Text Messages (CWT)
n=377 participants at risk
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.
|
|---|---|---|
|
Social circumstances
Death - Probably not related to a study device
|
0.27%
1/377 • Up to 24 months
|
0.00%
0/377 • Up to 24 months
|
Other adverse events
Adverse event data not reported
Additional Information
Belinda Borrelli, PhD
Boston University Henry M. Goldman School of Dental Medicine
Phone: 617-358-3358
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place