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| ID | Type | Description | Link |
|---|---|---|---|
| UH3DE025483 | 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 study assesses the impact of oral health promotion delivered by community health workers in medical clinics, Women, Infants and Children (WIC) centers, and family homes. Investigators will assess oral health behaviors in children aged 0 to 3.
Dental caries is the most common chronic disease of childhood; an estimated 28% of children nationally aged 5 years and below have untreated dental disease. Pediatric dental caries are associated with pain, more severe infections, malnutrition, speech difficulties, poor school performance, cosmetic problems, and an overall lower quality of life. Similar to other chronic diseases, oral health disparities are seen with higher caries prevalence and worse outcomes in children from low income urban families and in children of African American and Latino ethnicity. These disparities have been demonstrated locally in Chicago. Many interventions have been implemented to attempt to reverse these disparities. Some involve public policy (fluorinated water), some are educational campaigns targeting individuals, while others focus on providing increased education and services through primary healthcare providers. Many of these programs have demonstrated efficacy but the disparities in oral health persist. The investigators propose this is because the interventions to date do not target the family as a whole and also have not targeted multiple levels simultaneously.
COordinated Oral health Promotion (CO-OP) Chicago brings together a team of clinical pediatricians and dentists, health researchers, and policy experts to rigorously test the ability of multiple oral health promotion interventions, both alone and in combination, to improve child and family oral health. The primary intervention is family-focused education and support from community health workers (CHWs). CO-OP Chicago will test the impact of a family-focused CHW intervention for oral health promotion when applied in clinical, community, and home settings. The primary study objective is to evaluate the efficacy of a one-year oral health CHW intervention, compared to usual care, to improve self-reported brushing frequency and observed plaque score in low income urban children under the age of 3 years old. The study's exploratory aim is to determine if the oral health CHW intervention impact on child tooth brushing behaviors varies when the CHWs are based out of a medical clinic compared to a community WIC center.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHW Arm | Experimental | The intervention is community health worker (CHW) services. CHWs trained in oral health will be assigned to half of the sites. Participants in these sites will be offered four in-person visits and follow-up phone calls over 12-months. These visits can occur at the location of the family's preference (recruitment site, home, or mutually-agreed upon other location). A core curriculum of oral health topics will be covered during visits, with an emphasis on developing and sustaining healthy oral health management routines for the entire family. |
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| Wait-list Control Arm | No Intervention | This arm will receive usual care. After completion of the final data collection at one year, participants and sites allotted to this arm will be offered CHW services. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community Health Worker (CHW) services | Behavioral | CHWs are non-clinical people who provide education, care coordination, and support to families. |
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| Measure | Description | Time Frame |
|---|---|---|
| Parent-reported Tooth Brushing Frequency | parents will be asked how often the child's teeth are brushed | 12-months post-randomization |
| Child Dental Plaque Score | Disclosing solution is applied to child's teeth, images are taken, and plaque score is determined using the Oral health Index - Maxillary Incisor Score (OHI-MIS). The buccal surfaces of teeth #D, E, F, and G were scored from 0-3, with 3 being the worst (plaque on more than 2/3 of tooth surface) and 0 being the best (no plaque present). The four individual tooth scores (or less if child did not have four teeth) were then added and divided by the number of teeth for a final average score ranging from 0-3. | 12-months post-randomization |
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Inclusion Criteria:
Caregiver:
Child:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CEDA WIC Center Blue Island | Blue Island | Illinois | 60406 | United States | ||
| Chicago Department of Public Health WIC Centers (Greater Lawn Health Center, Friend Family Health Center, Westside Health Partnership) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35766288 | Derived | Martin MA, Avenetti D, Lee HH, Nordgren R, Berbaum ML, Edomwande Y, Cui L, Sandoval A. Community health worker intervention to improve tooth brushing in young children: Results from a cluster randomized controlled trial. Community Dent Oral Epidemiol. 2023 Jun;51(3):503-511. doi: 10.1111/cdoe.12768. Epub 2022 Jun 29. | |
| 31899372 | Derived | Martin MA, Zimmerman LJ, Rosales GF, Lee HH, Songthangtham N, Pugach O, Sandoval AS, Avenetti D, Alvarez G, Gansky SA. Design and sample characteristics of COordinated Oral health Promotion (CO-OP) Chicago: A cluster-randomized controlled trial. Contemp Clin Trials. 2020 May;92:105919. doi: 10.1016/j.cct.2019.105919. Epub 2019 Dec 30. |
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Three years after the end of the CO-OP Chicago research activity, data will be publicly released. Data will be maintained by the study team, in partnership with the community clinical partner. Registration will be required to access or download data files. Registered users will receive technical assistance with questions or problems from the Methodology Research Core (MRC) at the University of Illinois at Chicago's Institute for Health Research and Policy or from the UCSF Coordinating Center. A data sharing agreement will be required that will describe the conditions and restrictions of their use; limited data access will be made available only to users who successfully complete a rigorous approval process by both the investigators and the community partners. Data sets will be encrypted for transfer to approved investigators.
These details are not fully developed.
These details are not fully developed.
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| ID | Title | Description |
|---|---|---|
| FG000 | CHW Arm | The intervention is community health worker (CHW) services. CHWs trained in oral health will be assigned to half of the sites. Participants in these sites will be offered four in-person visits and follow-up phone calls over 12-months. These visits can occur at the location of the family's preference (recruitment site, home, or mutually-agreed upon other location). A core curriculum of oral health topics will be covered during visits, with an emphasis on developing and sustaining healthy oral health management routines for the entire family. Community Health Worker (CHW) services: CHWs are non-clinical people who provide education, care coordination, and support to families. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 19, 2018 |
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cluster-randomized two arm trial with wait list control
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Because of the nature of the intervention, participants will know after randomization which arm they are in. Outcomes assessors and data analysts will be masked to study arm. Most investigators will be masked to study arm.
| Chicago |
| Illinois |
| 60604 |
| United States |
| Mile Square Health Center (Main, Englewood, Cicero, South Shore, Back of the Yards) | Chicago | Illinois | 60608 | United States |
| University of Illinois at Chicago Outpatient Care Center | Chicago | Illinois | 60612 | United States |
| Aunt Martha's Southeast Side Community Health Center | Chicago | Illinois | 60617 | United States |
| Vida Pediatrics | Chicago | Illinois | 60629 | United States |
| CEDA WIC Centers (Diversey, Irving Park) | Chicago | Illinois | 60661 | United States |
| Aunt Martha's Pediatric Health & Wellness Center | Chicago Heights | Illinois | 60411 | United States |
| CEDA WIC Center Harvey | Harvey | Illinois | 60426 | United States |
| CEDA WIC Center Maywood | Maywood | Illinois | 60153 | United States |
| CEDA WIC Oak Park | Oak Park | Illinois | 60304 | United States |
| Aunt Martha's South Holland Community Health Center | South Holland | Illinois | 60473 | United States |
| CEDA WIC Summit | Summit | Illinois | 60501 | United States |
| FG001 | Wait-list Control Arm | This arm will receive usual care. After completion of the final data collection at one year, participants and sites allotted to this arm will be offered CHW services. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | CHW Arm | The intervention is community health worker (CHW) services. CHWs trained in oral health will be assigned to half of the sites. Participants in these sites will be offered four in-person visits and follow-up phone calls over 12-months. These visits can occur at the location of the family's preference (recruitment site, home, or mutually-agreed upon other location). A core curriculum of oral health topics will be covered during visits, with an emphasis on developing and sustaining healthy oral health management routines for the entire family. Community Health Worker (CHW) services: CHWs are non-clinical people who provide education, care coordination, and support to families. |
| BG001 | Wait-list Control Arm | This arm will receive usual care. After completion of the final data collection at one year, participants and sites allotted to this arm will be offered CHW services. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Parent-reported Tooth Brushing Frequency | parents will be asked how often the child's teeth are brushed | Posted | Count of Participants | Participants | 12-months post-randomization |
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| Primary | Child Dental Plaque Score | Disclosing solution is applied to child's teeth, images are taken, and plaque score is determined using the Oral health Index - Maxillary Incisor Score (OHI-MIS). The buccal surfaces of teeth #D, E, F, and G were scored from 0-3, with 3 being the worst (plaque on more than 2/3 of tooth surface) and 0 being the best (no plaque present). The four individual tooth scores (or less if child did not have four teeth) were then added and divided by the number of teeth for a final average score ranging from 0-3. | Posted | Mean | Standard Deviation | score on a scale | 12-months post-randomization |
|
Adverse events were collected for each participant over a 1 year period, from enrollment through the 1 year data collection.
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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 | CHW Arm | The intervention is community health worker (CHW) services. CHWs trained in oral health will be assigned to half of the sites. Participants in these sites will be offered four in-person visits and follow-up phone calls over 12-months. These visits can occur at the location of the family's preference (recruitment site, home, or mutually-agreed upon other location). A core curriculum of oral health topics will be covered during visits, with an emphasis on developing and sustaining healthy oral health management routines for the entire family. Community Health Worker (CHW) services: CHWs are non-clinical people who provide education, care coordination, and support to families. | 0 | 211 | 0 | 211 | 0 | 211 |
| EG001 | Wait-list Control Arm | This arm will receive usual care. After completion of the final data collection at one year, participants and sites allotted to this arm will be offered CHW services. | 0 | 209 | 0 | 209 | 0 | 209 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Molly A Martin, MD | University of Illinois Chicago | 312-996-2363 | mollyma@uic.edu |
| Sep 30, 2021 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D003150 | Community Health Workers |
| ID | Term |
|---|---|
| D000488 | Allied Health Personnel |
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Once a day brush |
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| Twice a day brush |
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| More than twice a day brush |
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