Coordinated Oral Health Promotion (CO-OP) Chicago
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03397589|
Recruitment Status : Completed
First Posted : January 12, 2018
Results First Posted : December 9, 2021
Last Update Posted : December 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|Dental Caries in Children Health Behavior Healthcare Disparities||Behavioral: Community Health Worker (CHW) services||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||420 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||cluster-randomized two arm trial with wait list control|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||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.|
|Official Title:||Coordinated Oral Health Promotion (CO-OP) Chicago|
|Actual Study Start Date :||January 12, 2018|
|Actual Primary Completion Date :||August 20, 2020|
|Actual Study Completion Date :||August 20, 2020|
Experimental: 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.
Behavioral: Community Health Worker (CHW) services
CHWs are non-clinical people who provide education, care coordination, and support to families.
No Intervention: 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.
- Parent-reported Tooth Brushing Frequency [ Time Frame: 12-months post-randomization ]parents will be asked how often the child's teeth are brushed
- Child Dental Plaque Score [ Time Frame: 12-months post-randomization ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03397589
|United States, Illinois|
|CEDA WIC Center Blue Island|
|Blue Island, Illinois, United States, 60406|
|Aunt Martha's Pediatric Health & Wellness Center|
|Chicago Heights, Illinois, United States, 60411|
|Chicago Department of Public Health WIC Centers (Greater Lawn Health Center, Friend Family Health Center, Westside Health Partnership)|
|Chicago, Illinois, United States, 60604|
|Mile Square Health Center (Main, Englewood, Cicero, South Shore, Back of the Yards)|
|Chicago, Illinois, United States, 60608|
|University of Illinois at Chicago Outpatient Care Center|
|Chicago, Illinois, United States, 60612|
|Aunt Martha's Southeast Side Community Health Center|
|Chicago, Illinois, United States, 60617|
|Chicago, Illinois, United States, 60629|
|CEDA WIC Centers (Diversey, Irving Park)|
|Chicago, Illinois, United States, 60661|
|CEDA WIC Center Harvey|
|Harvey, Illinois, United States, 60426|
|CEDA WIC Center Maywood|
|Maywood, Illinois, United States, 60153|
|CEDA WIC Oak Park|
|Oak Park, Illinois, United States, 60304|
|Aunt Martha's South Holland Community Health Center|
|South Holland, Illinois, United States, 60473|
|CEDA WIC Summit|
|Summit, Illinois, United States, 60501|