Coordinated Oral Health Promotion (CO-OP) Chicago

University of Illinois

Status: Completed

Conditions: Dental Caries in Children; Health Behavior; Healthcare Disparities

Treatments: Behavioral: Community Health Worker (CHW) services

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03397589

2017-1090

UH3DE025483 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 420 patients

Sex: All

Ages: 6 to 36 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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420 participants in 2 patient groups

CHW Arm

Experimental group

Description:

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.

Treatment:

Behavioral: Community Health Worker (CHW) services

Wait-list Control Arm

No Intervention group

Description:

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.