Coordinated Oral Health Promotion (CO-OP) Chicago

• 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: University of Illinois at Chicago
• Collaborator: National Institute of Dental and Craniofacial Research (NIDCR)
• Information provided by (Responsible Party): Molly A. Martin, University of Illinois at Chicago

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

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:

Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] March 19, 2018

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Dental Caries; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases