Coordinated Oral Health Promotion (CO-OP) Chicago

• Sponsor: University of Illinois at Chicago (Other)
• Overall Status: Completed
• CT.gov ID: NCT03397589
• Collaborator: National Institute of Dental and Craniofacial Research (NIDCR) (NIH)
• Enrollment: 420
• Locations: 13
• Arms: 2
• Actual Duration (Months): 31.2
• Patients Per Site: 32.3
• Patients Per Site Per Month: 1

Study Details

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	N/A

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
• Actual Enrollment: 420 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: cluster-randomized two arm trial with wait list controlcluster-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: Jan 12, 2018
• Actual Primary Completion Date: Aug 20, 2020
• Actual Study Completion Date: Aug 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 [12-months post-randomization]

   parents will be asked how often the child's teeth are brushed

2. Child Dental Plaque Score [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

Criteria

• Ages Eligible for Study: 6 Months to 36 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

	Site	City	State	Country	Postal Code
1	CEDA WIC Center Blue Island	Blue Island	Illinois	United States	60406
2	Aunt Martha's Pediatric Health & Wellness Center	Chicago Heights	Illinois	United States	60411
3	Chicago Department of Public Health WIC Centers (Greater Lawn Health Center, Friend Family Health Center, Westside Health Partnership)	Chicago	Illinois	United States	60604
4	Mile Square Health Center (Main, Englewood, Cicero, South Shore, Back of the Yards)	Chicago	Illinois	United States	60608
5	University of Illinois at Chicago Outpatient Care Center	Chicago	Illinois	United States	60612
6	Aunt Martha's Southeast Side Community Health Center	Chicago	Illinois	United States	60617
7	Vida Pediatrics	Chicago	Illinois	United States	60629
8	CEDA WIC Centers (Diversey, Irving Park)	Chicago	Illinois	United States	60661
9	CEDA WIC Center Harvey	Harvey	Illinois	United States	60426
10	CEDA WIC Center Maywood	Maywood	Illinois	United States	60153
11	CEDA WIC Oak Park	Oak Park	Illinois	United States	60304
12	Aunt Martha's South Holland Community Health Center	South Holland	Illinois	United States	60473
13	CEDA WIC Summit	Summit	Illinois	United States	60501

Sponsors and Collaborators

• University of Illinois at Chicago
• National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Mar 19, 2018

More Information

Publications

None provided.

• Responsible Party: Molly A. Martin, Associate Professor, University of Illinois at Chicago
• ClinicalTrials.gov Identifier: NCT03397589
• Other Study ID Numbers: 2017-1090; UH3DE025483
• First Posted: Jan 12, 2018
• Last Update Posted: Dec 9, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dental Caries

Study Results

Participant Flow

Arm/Group Title	CHW Arm	Wait-list Control Arm
Arm/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. Community Health Worker (CHW) services: CHWs are non-clinical people who provide education, care coordination, and support to families.	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.
Period Title: Overall Study
STARTED	211	209
COMPLETED	175	187
NOT COMPLETED	36	22

Baseline Characteristics

Arm/Group Title	CHW Arm	Wait-list Control Arm	Total
Arm/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. Community Health Worker (CHW) services: CHWs are non-clinical people who provide education, care coordination, and support to families.	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.	Total of all reporting groups
Overall Participants	211	209	420
Age (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	22.4 (6.8)	20.8 (7.0)	21.5 (6.9)
Sex: Female, Male (Count of Participants)
Female	104 49.3%	109 52.2%	213 50.7%
Male	107 50.7%	100 47.8%	207 49.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	115 54.5%	111 53.1%	226 53.8%
Not Hispanic or Latino	96 45.5%	98 46.9%	194 46.2%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	92 43.6%	84 40.2%	176 41.9%
White	21 10%	36 17.2%	57 13.6%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	98 46.4%	89 42.6%	187 44.5%

Outcome Measures

1. Primary Outcome

Title	Parent-reported Tooth Brushing Frequency
Description	parents will be asked how often the child's teeth are brushed
Time Frame	12-months post-randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CHW Arm	Wait-list Control Arm
Arm/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. Community Health Worker (CHW) services: CHWs are non-clinical people who provide education, care coordination, and support to families.	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.
Measure Participants	175	187
Never brush	1 0.5%	1 0.5%
Sometimes, but not everyday brush	12 5.7%	15 7.2%
Once a day brush	56 26.5%	49 23.4%
Twice a day brush	85 40.3%	105 50.2%
More than twice a day brush	21 10%	17 8.1%

2. Primary Outcome

Title	Child Dental Plaque Score
Description	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.
Time Frame	12-months post-randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CHW Arm	Wait-list Control Arm
Arm/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. Community Health Worker (CHW) services: CHWs are non-clinical people who provide education, care coordination, and support to families.	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.
Measure Participants	161	160
Mean (Standard Deviation) [score on a scale]	1.88 (0.64)	1.85 (0.66)

Adverse Events

Time Frame	Adverse events were collected for each participant over a 1 year period, from enrollment through the 1 year data collection.
Arm/Group Title	CHW Arm		Wait-list Control Arm
Arm/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. Community Health Worker (CHW) services: CHWs are non-clinical people who provide education, care coordination, and support to families.		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.
All Cause Mortality
	CHW Arm		Wait-list Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/211 (0%)		0/209 (0%)
Serious Adverse Events
	CHW Arm		Wait-list Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/211 (0%)		0/209 (0%)
Other (Not Including Serious) Adverse Events
	CHW Arm		Wait-list Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/211 (0%)		0/209 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.