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Trial record 1 of 1 for:    oral health | Chicago, Illinois, U.S.
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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
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Molly A. Martin, University of Illinois at Chicago

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dental Caries in Children Health Behavior Healthcare Disparities Behavioral: Community Health Worker (CHW) services Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 420 participants
Allocation: Randomized
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.
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Parent-reported Tooth Brushing Frequency [ Time Frame: 12-months post-randomization ]
    parents will be asked how often the child's teeth are brushed

  2. 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.



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Ages Eligible for Study:   6 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Caregiver:

  • Provide a signed and dated informed consent form
  • Age 18 or older
  • Be the primary caregiver of a child age 6-36 months old. The primary caregiver is defined for this study as the person (or one of the people) who is consistently responsible for the child's daily routines and who is a legal guardian.
  • If a child lives in multiple households, the caregiver must live with the child at least 5 days of the week.
  • The child must be an active patient/client in the clinic/center where recruited.
  • Speak English or Spanish
  • Willing to comply with all study procedures and be available for the duration of the study

Child:

  • Age 6-36 months old
  • An active patient/client in the clinic/center where recruited
  • A minimum of two fully erupted central maxillary incisors

Exclusion Criteria:

  • Child with medical condition that limits his or her ability to conduct the study activities (such as severe developmental or cognitive delay, ventilator or oxygen dependence, oral aversion, severe facial deformities)
  • Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study
  • Anything that would place the research or intervention staff at increased risk

Information from the National Library of Medicine

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


Locations
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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
Vida Pediatrics
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
Sponsors and Collaborators
University of Illinois at Chicago
National Institute of Dental and Craniofacial Research (NIDCR)
  Study Documents (Full-Text)

Documents provided by Molly A. Martin, University of Illinois at Chicago:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Molly A. Martin, Associate Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT03397589    
Other Study ID Numbers: 2017-1090
UH3DE025483 ( U.S. NIH Grant/Contract )
First Posted: January 12, 2018    Key Record Dates
Results First Posted: December 9, 2021
Last Update Posted: December 9, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Time Frame: These details are not fully developed.
Access Criteria: These details are not fully developed.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases