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| ID | Type | Description | Link |
|---|---|---|---|
| 4UH3DE025492-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
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This is a randomized clinical trial to test the efficacy of a parent-targeted text message-based intervention program on caries incidence and oral health behaviors (child and parent). Parents (n= 850) across all pediatric clinic sites (Boston Medical Center and Community Health Centers (CHCs); DotHouse CHC, South End Community Health Center, and Codman Square CHC) will be randomized to receive either text messages (TMs) regarding oral health or TMs regarding child wellness. The study will enroll English and Spanish speaking parents and their youngest child who is < 7 years old, has at least one tooth showing, and attends the targeted pediatric clinic to receive primary care (n= 1700). Parents will complete self-report surveys at baseline, and 2, 4, 12, and 24-months after baseline; receive and respond to TM assessments during the 4-month intervention; and will also receive TMs during a 'booster' period of one month, which will occur 12-months post baseline. Parent's children will be assessed for caries by a clinical oral examination performed by licensed Clinical Examiners at baseline, 12-and-24-months post-baseline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral health text messages (OHT) | Experimental | 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. |
|
| Child wellness text messages (CWT) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OHT Parent targeted text messages | Other | For the Oral health text message (OHT) group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to oral health. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 24-month time point (oral assessment) |
| 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) | 4-month time point (survey) |
| 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) | 4-month time point (survey) |
| 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). | 4-month time point (survey) |
| 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). | 4-month time point (survey) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4-month time point (survey) |
| Parents' Perceived Impact of iSmile |
| Measure | Description | Time Frame |
|---|---|---|
| Type of Beverage Consumed Between Meals | Parent/caregiver participants are asked to indicate what beverage their child consumes most often between meals. | 4-month, 12-month, and 24-month time points (survey) |
| Challenge Week During the OHT Text Message Program |
Inclusion Criteria: Caregiver and child must meet all of the following:
Exclusion Criteria: If the caregiver or child meets any of the following criteria, the dyad will be excluded from participation in this study
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| Name | Affiliation | Role |
|---|---|---|
| Belinda Borrelli, PhD | Henry M. Goldman School of Dental Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39745701 | Derived | Borrelli B, Endrighi R, Heeren T, Adams WG, Gansky SA, Werntz S, Rueras N, Stephens D, Ameli N, Henshaw MM. Parent-Targeted Oral Health Text Messaging for Underserved Children Attending Pediatric Clinics: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jan 2;8(1):e2452780. doi: 10.1001/jamanetworkopen.2024.52780. |
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754 dyads (parents or caregivers and child) were enrolled and randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
754 parent/caregiver-child dyads were assessed for baseline measures (total 1,508 participants)
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean age of parent/caregiver and children participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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) | Posted | Count of Participants | Participants | 24-month time point (oral assessment) |
|
Up to 24 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death - Probably not related to a study device | Social circumstances | Non-systematic Assessment | Study team made a retention call for a follow-up survey on 10/14/20. A family member picked up and informed us that the parent/caregiver participant had died. No other details were disclosed. Study team ascertained that the death occurred 02/15/20. |
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Due to the COVID-19 pandemic, on March 12, 2020 Boston University Medical campus and Boston Medical Center IRB declared an immediate halt of in-person research activities. This resulted in a less than expected number of children attending the 12 and/or the 24 month oral health assessments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Belinda Borrelli, PhD | Boston University Henry M. Goldman School of Dental Medicine | 617-358-3358 | belindab@bu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 29, 2019 | Nov 17, 2022 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 29, 2019 | May 19, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D001519 | Behavior |
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Outcome Assessors and Oral Health Examiners will be blind to treatment condition.
| CWT Parent targeted text messages | Other | For the CWT group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to child wellness. |
|
| 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). | 24-month time point (oral assessment) |
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). |
| 4-month time point (survey) |
| 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. | 4-month, 12-month, and 24-month time points (survey) |
| 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. | 4-month, 12-month, and 24-month time points (survey) |
| 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. | 24-month (survey) |
| 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). | 4-month, 12-month, and 24-month time points (survey) |
| 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). | 4-month, 12-month, and 24-month time points (survey) |
| 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). | 4-month, 12-month, and 24-month time points (survey) |
| 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). | 4-month, 12-month, and 24-month time points (survey) |
| 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). | 4-month, 12-month, and 24-month time points (survey) |
| 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). | 4-month time point (survey) |
| 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. | 4-month, 12-month, and 24-month time points (survey) |
| 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. | 4-month, 12-month, and 24-month time points (survey) |
| 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 | 4-month time point (survey) |
| 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. | 4-month time point (survey) |
| 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). | 4-month time point (survey) |
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. |
| 4-month time point |
| Dental Caries (Per Subject) | Number of primary teeth with new dental caries per child | 24-Month (oral health assessment) |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Sex of parent/caregiver and children participants | 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Ethnicity of parent/caregiver and children participants | 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race of parent/caregiver and children participants | 754 Parent/caregiver-child dyads were assessed for baseline measures for a total of 1,508 participants | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
| 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) | Scores on a self-efficacy measure (range 1 - 4; higher scores mean better outcome) | Posted | Mean | Standard Deviation | score on a scale | 4-month time point (survey) |
|
|
|
| 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) | Scores on a motivation measure (range 1 - 7; higher scores mean better outcome) | Posted | Mean | Standard Deviation | score on a scale | 4-month time point (survey) |
|
|
|
| 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). | Scores on an outcome expectancies measure (range 1 - 4; higher scores mean better outcome) | Posted | Mean | Standard Deviation | score on a scale | 4-month time point (survey) |
|
|
|
| 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). | Scores on a confidence (self-efficacy) measure (range 1 - 7; higher scores mean better outcome) | Posted | Mean | Standard Deviation | score on a scale | 4-month time point (survey) |
|
|
|
| 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). | Number of tooth surfaces with new caries in children participants | Posted | Count of Units | Tooth surfaces | 24-month time point (oral assessment) | Tooth surfaces | Tooth surfaces |
|
|
|
| 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. | 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?" | Posted | Count of Participants | Participants | 4-month time point (survey) |
|
|
|
| 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). | 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) | Posted | Mean | Standard Deviation | units on a scale | 4-month time point (survey) |
|
|
|
| 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. | Number of parent/caregiver participants who indicated that their child had a preventive dental visit. | Posted | Count of Participants | Participants | 4-month, 12-month, and 24-month time points (survey) |
|
|
|
| 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. | Number of parent/caregiver participants indicating use of fluoridated toothpaste to brush their child's teeth. | Posted | Count of Participants | Participants | 4-month, 12-month, and 24-month time points (survey) |
|
|
|
| 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. | 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') | Posted | Count of Participants | Participants | 24-month (survey) |
|
|
|
| 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). | The estimated cariogenic score derived from a food frequency questionnaire (higher scores mean a worse outcome). | Posted | Mean | Standard Deviation | score on a scale | 4-month, 12-month, and 24-month time points (survey) |
|
|
|
| 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). | 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"). | Posted | Count of Participants | Participants | 4-month, 12-month, and 24-month time points (survey) |
|
|
|
| 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). | Number of child tooth brushings per week (range: 0 - 21; higher scores mean a better outcome) | Posted | Mean | Standard Deviation | units on a scale | 4-month, 12-month, and 24-month time points (survey) |
|
|
|
| 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). | Number of parent/caregiver participants tooth brushings per week (range: 0 - 21; higher scores mean a better outcome). | Posted | Mean | Standard Deviation | units on a scale | 4-month, 12-month, and 24-month time points (survey) |
|
|
|
| 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). | The Early Childhood Oral Health 'Family' Impact scale score (range 0 - 16; higher scores mean a worse outcome) | Posted | Mean | Standard Deviation | score on a scale | 4-month, 12-month, and 24-month time points (survey) |
|
|
|
| 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). | 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) | Posted | Mean | Standard Deviation | units on a scale | 4-month time point (survey) |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | 4-month, 12-month, and 24-month time points (survey) |
|
|
|
| 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. | Number of parent/caregiver participants who indicated that they brushed their teeth at least two times per day, seven days of the week. | Posted | Count of Participants | Participants | 4-month, 12-month, and 24-month time points (survey) |
|
|
|
| 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 | 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. | Posted | Count of Participants | Participants | 4-month time point (survey) |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | 4-month time point (survey) |
|
|
|
| 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). | 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). | Posted | Mean | Standard Deviation | units on a scale | 4-month time point (survey) |
|
|
|
| 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. | Number of parent/caregiver participants indicating that their child consumed the beverage between meals. | Posted | Count of Participants | Participants | 4-month, 12-month, and 24-month time points (survey) |
|
|
|
| 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. | Number of parent/caregiver participants in the OHT arm who agreed to do the challenge. | Posted | Count of Participants | Participants | 4-month time point |
|
|
|
| Other Pre-specified | Dental Caries (Per Subject) | Number of primary teeth with new dental caries per child | Number of primary teeth with new dental caries per child | Posted | Count of Participants | Participants | 24-Month (oral health assessment) |
|
|
|
| 1 |
| 377 |
| 1 |
| 377 |
| 0 |
| 377 |
| EG001 | 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. | 0 | 377 | 0 | 377 | 0 | 377 |
|
Not provided
Not provided
Not provided
| Male |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| The program should be shorter |
|
|
| 12-month |
|
|
| 4-month |
|
|
| 12-month |
|
|
| 4-month |
|
|
| 4 - |
|
| 5 - strongly agree |
|
| prefer not to answer |
|
| 12-month |
|
|
| 4-month |
|
|
| 12-month |
|
|
| 4-month |
|
|
| 12-month |
|
|
| 4-month |
|
|
| 12-month |
|
|
| 4-month |
|
|
| 12-month |
|
|
| 4-month |
|
|
| 12-Month |
|
|
| 4-Month |
|
|
| 12-Month |
|
|
| 4-Month |
|
|
| 3 stars |
|
| 4 stars |
|
| 5 stars |
|
| prefer not to answer |
|
| Content of TMs easy to understand |
|
| Easy to integrate into day/routine |
|
| Language appropriate |
|
| Relevant for you and your child |
|
| 2. Juice or juice drinks |
|
| 3. Diet soda pop or other sugar free beverages |
|
| 4. Water |
|
| 5. Regular soda pop or other sugared beverages |
|
| 6. Flavored milk |
|
| 7. Other |
|
| Do not know |
|
| Prefer not to answer |
|
| 12-Month |
|
|
| 4-Month |
|
|
| 2 teeth with new caries |
|
| 3 to 5 teeth with new caries |
|
| 6 or more teeth with new caries |
|