Clinical trial NCT03397589: Coordinated Oral Health Promotion (CO-OP) Chicago
Official title: Coordinated Oral Health Promotion (CO-OP) Chicago
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries in Children
Health Behavior
Healthcare Disparities
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2018-01-12
Enrollment: 420
Sex: ALL
Minimum age (years): 6
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: cluster-randomized two arm trial with wait list control
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: Parent-reported Tooth Brushing Frequency
timeFrame: 12-months post-randomization
measure: Child Dental Plaque Score
timeFrame: 12-months post-randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Blue Island
country: United States
facility: CEDA WIC Center Blue Island
state: Illinois
city: Chicago Heights
country: United States
facility: Aunt Martha's Pediatric Health & Wellness Center
state: Illinois
city: Chicago
country: United States
facility: Chicago Department of Public Health WIC Centers (Greater Lawn Health Center, Friend Family Health Center, Westside Health Partnership)
state: Illinois
city: Chicago
country: United States
facility: Mile Square Health Center (Main, Englewood, Cicero, South Shore, Back of the Yards)
state: Illinois
city: Chicago
country: United States
facility: University of Illinois at Chicago Outpatient Care Center
state: Illinois
city: Chicago
country: United States
facility: Aunt Martha's Southeast Side Community Health Center
state: Illinois
city: Chicago
country: United States
facility: Vida Pediatrics
state: Illinois
city: Chicago
country: United States
facility: CEDA WIC Centers (Diversey, Irving Park)
state: Illinois
city: Harvey
country: United States
facility: CEDA WIC Center Harvey
state: Illinois
city: Maywood
country: United States
facility: CEDA WIC Center Maywood
state: Illinois
city: Oak Park
country: United States
facility: CEDA WIC Oak Park
state: Illinois
city: South Holland
country: United States
facility: Aunt Martha's South Holland Community Health Center
state: Illinois
city: Summit
country: United States
facility: CEDA WIC Summit
state: Illinois
Study officials:
References:
citation: 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.