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)
420
13
2
31.2
32.3
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
  • 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)

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:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
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.
Adverse Event Reporting Description
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.

Results Point of Contact

Name/Title Molly A Martin, MD
Organization University of Illinois Chicago
Phone 312-996-2363
Email mollyma@uic.edu
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