Coordinated Oral Health Promotion (CO-OP) Chicago
2 other identifiers
interventional
420
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2018
Typical duration for not_applicable
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2017
CompletedFirst Posted
Study publicly available on registry
January 12, 2018
CompletedStudy Start
First participant enrolled
January 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2020
CompletedResults Posted
Study results publicly available
December 9, 2021
CompletedOctober 18, 2022
October 1, 2022
2.6 years
December 22, 2017
September 30, 2021
October 13, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Parent-reported Tooth Brushing Frequency
parents will be asked how often the child's teeth are brushed
12-months post-randomization
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
Study Arms (2)
CHW Arm
EXPERIMENTALThe 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.
Wait-list Control Arm
NO INTERVENTIONThis 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.
Interventions
CHWs are non-clinical people who provide education, care coordination, and support to families.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
CEDA WIC Center Blue Island
Blue Island, Illinois, 60406, United States
Chicago Department of Public Health WIC Centers (Greater Lawn Health Center, Friend Family Health Center, Westside Health Partnership)
Chicago, Illinois, 60604, United States
Mile Square Health Center (Main, Englewood, Cicero, South Shore, Back of the Yards)
Chicago, Illinois, 60608, United States
University of Illinois at Chicago Outpatient Care Center
Chicago, Illinois, 60612, United States
Aunt Martha's Southeast Side Community Health Center
Chicago, Illinois, 60617, United States
Vida Pediatrics
Chicago, Illinois, 60629, United States
CEDA WIC Centers (Diversey, Irving Park)
Chicago, Illinois, 60661, United States
Aunt Martha's Pediatric Health & Wellness Center
Chicago Heights, Illinois, 60411, United States
CEDA WIC Center Harvey
Harvey, Illinois, 60426, United States
CEDA WIC Center Maywood
Maywood, Illinois, 60153, United States
CEDA WIC Oak Park
Oak Park, Illinois, 60304, United States
Aunt Martha's South Holland Community Health Center
South Holland, Illinois, 60473, United States
CEDA WIC Summit
Summit, Illinois, 60501, United States
Related Publications (2)
Martin MA, Avenetti D, Lee HH, Nordgren R, Berbaum ML, Edomwande Y, Cui L, Sandoval A. Community health worker intervention to improve tooth brushing in young children: Results from a cluster randomized controlled trial. Community Dent Oral Epidemiol. 2023 Jun;51(3):503-511. doi: 10.1111/cdoe.12768. Epub 2022 Jun 29.
PMID: 35766288DERIVEDMartin 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.
PMID: 31899372DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Molly A Martin, MD
- Organization
- University of Illinois Chicago
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 22, 2017
First Posted
January 12, 2018
Study Start
January 20, 2018
Primary Completion
August 20, 2020
Study Completion
August 20, 2020
Last Updated
October 18, 2022
Results First Posted
December 9, 2021
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- These details are not fully developed.
- Access Criteria
- These details are not fully developed.
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.