Coordinated Oral Health Promotion (CO-OP) Chicago

Health Behavior Clinical Trial

Official title:

Coordinated Oral Health Promotion (CO-OP) Chicago

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03397589
• Other study ID #: 2017-1090
• Secondary ID: UH3DE025483
• Status: Completed
• Phase: N/A
• Start date: January 20, 2018
• Est. completion date: August 20, 2020

Study information

• Verified date: October 2022
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: August 20, 2020
• Est. primary completion date: August 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 36 Months

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children
• Health Behavior
• Healthcare Disparities

Intervention

Behavioral:
• Community Health Worker (CHW) services
CHWs are non-clinical people who provide education, care coordination, and support to families.

Locations

Country	Name	City	State
United States	CEDA WIC Center Blue Island	Blue Island	Illinois
United States	Aunt Martha's Southeast Side Community Health Center	Chicago	Illinois
United States	CEDA WIC Centers (Diversey, Irving Park)	Chicago	Illinois
United States	Chicago Department of Public Health WIC Centers (Greater Lawn Health Center, Friend Family Health Center, Westside Health Partnership)	Chicago	Illinois
United States	Mile Square Health Center (Main, Englewood, Cicero, South Shore, Back of the Yards)	Chicago	Illinois
United States	University of Illinois at Chicago Outpatient Care Center	Chicago	Illinois
United States	Vida Pediatrics	Chicago	Illinois
United States	Aunt Martha's Pediatric Health & Wellness Center	Chicago Heights	Illinois
United States	CEDA WIC Center Harvey	Harvey	Illinois
United States	CEDA WIC Center Maywood	Maywood	Illinois
United States	CEDA WIC Oak Park	Oak Park	Illinois
United States	Aunt Martha's South Holland Community Health Center	South Holland	Illinois
United States	CEDA WIC Summit	Summit	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parent-reported Tooth Brushing Frequency	parents will be asked how often the child's teeth are brushed	12-months post-randomization
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.	12-months post-randomization