Dental Caries in ChildrenNCT03397589
Coordinated Oral Health Promotion (CO-OP) Chicago
A study testing Community Health Worker (CHW) services in people with Dental Caries in Children and Health Behavior, run by University of Illinois Chicago at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children, Health Behavior, Healthcare Disparities
- What is being tested?
- Community Health Worker (CHW) services
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 13 sitesUnited States
- Study dates
- 20 Jan 2018to 20 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Show all 12Show fewer
- 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
Who cannot join
- 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 locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
CEDA WIC Center Blue Island
Blue Island, Illinois, 60406
Chicago Department of Public Health WIC Centers (Greater Lawn Health Center, Friend Family Health Center, Westside Health Partnership)
Chicago, Illinois, 60604
Mile Square Health Center (Main, Englewood, Cicero, South Shore, Back of the Yards)
Chicago, Illinois, 60608
University of Illinois at Chicago Outpatient Care Center
Chicago, Illinois, 60612
Aunt Martha's Southeast Side Community Health Center
Chicago, Illinois, 60617
Vida Pediatrics
Chicago, Illinois, 60629
CEDA WIC Centers (Diversey, Irving Park)
Chicago, Illinois, 60661
Aunt Martha's Pediatric Health & Wellness Center
Chicago Heights, Illinois, 60411
CEDA WIC Center Harvey
Harvey, Illinois, 60426
CEDA WIC Center Maywood
Maywood, Illinois, 60153
CEDA WIC Oak Park
Oak Park, Illinois, 60304
Aunt Martha's South Holland Community Health Center
South Holland, Illinois, 60473
CEDA WIC Summit
Summit, Illinois, 60501
About this study
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.
Read the 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.
- Being tested
- Community Health Worker (CHW) services
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Health Worker (CHW) servicesBehavioural
CHWs are non-clinical people who provide education, care coordination, and support to families.
| Study group | Role | What they receive |
|---|---|---|
| CHW Arm | Experimental | 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. Receives: Behavioral: Community Health Worker (CHW) services |
| Wait-list Control Arm | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent-reported Tooth Brushing Frequency
parents will be asked how often the child's teeth are brushed
Measured: 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.
Measured: 12-months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start20 Jan 2018
- Primary completion20 Aug 2020
- Study completion20 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental Caries in ChildrenStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- cluster-randomized two arm trial with wait list control
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Principal investigator, Molly A. Martin, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03397589
- Sponsor's protocol ID
- 2017-1090
- Other IDs
- UH3DE025483
- Status last verified
- Oct 2022
- First submitted
- 22 Dec 2017
- Last updated
- 18 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 35766288Martin 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.
PubMed 31899372
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coordinated Oral Health Promotion (CO-OP) Chicago
- ClinicalTrials.gov ID
- NCT03397589
- Acronym / sponsor ID
- 2017-1090
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 20 Jan 2018 (actual)
- Primary completion
- 20 Aug 2020 (actual)
- Study completion
- 20 Aug 2020 (actual)
- First posted
- 12 Jan 2018 (actual)
- Results
- Posted 9 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- cluster-randomized two arm trial with wait list control
| Arm | Type | Receives |
|---|---|---|
| CHW Arm | Experimental | Behavioral: Community Health Worker (CHW) servicesThe 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 intervention | –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. |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community Health Worker (CHW) servicesCHWs are non-clinical people who provide education, care coordination, and support to families. | Behavioural | CHW Arm |
Primary outcome
Parent-reported Tooth Brushing Frequency
Time frame: 12-months post-randomization
parents will be asked how often the child's teeth are brushed
Child Dental Plaque Score
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35766288Martin 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.
- Derived from this study: PubMed 31899372Martin 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Health Worker (CHW) services in people with Dental Caries in Children and Health Behavior, run by University of Illinois Chicago at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent-reported Tooth Brushing Frequency (time frame: 12-months post-randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03397589, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2022.