An interventional study of Community Health Worker (CHW) services in Dental Caries in Children, Health Behavior and Healthcare Disparities, sponsored by University of Illinois at Chicago. Completed at 13 sites in United States. Open to participants aged 6 Months to 36 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-18.
Sponsored by University of Illinois at Chicago · Not applicable, Interventional, and Other
Among 421 studies in Health Behavior with a site in United States — 66 open to participants now, 86 under way, 1 of them phase 3. Health Behavior · United States.
Among the 421 studies in Health Behavior with a site in United States, this one is the 107th largest by enrollment of the 385 interventional ones that give a count, is one of 25 that started in 2018, is one of 363 with no phase, and was the 150th registered.
968 studies on the registry are indexed under Health Behavior; 166 are open to participants now.
Browse Health Behavior studies →66 of the 421 studies in Health Behavior with a site in United States are open now. Recruiting first, the newest first:
University of Alabama at Birmingham · Sites in United States
Ages 25–65
University of South Florida · Sites in United States
Ages 18–70
St. Jude Children's Research Hospital · Sites in United States
Ages 26+
William Brandenburg, MD · Sites in United States
Ages 18+ · Healthy volunteers
University of North Carolina, Chapel Hill · Sites in United States
Ages 21+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 93 Health Behavior studies recruiting now, 39 (42%) set no upper age limit and 37 (40%) stop at 75 or younger; 25 take children under 18; 58 take healthy volunteers.
This study: 6 Months to 36 Months · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
421 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 10 · Phase 3 6 · Phase 4 1
First in 1999; this study’s year is marked. 25 started in 2018.
This study's enrollment of 420 is above the median of 150 across 825 interventional studies indexed under Health Behavior.
Median enrollment 130 across the 385 interventional studies, 108 across the 36 observational. Of the 319 that completed or were terminated, 88 (28%) have results posted.
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18 of 421 have an industry lead sponsor. The 10 most frequent:
University of Illinois at Chicago is the lead sponsor of 504 studies on the registry; 119 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.
University of Illinois at Chicago has 3 studies filed under Health Behavior — fewer than ten, so there is no comparison to draw.
26 of the studies in Health Behavior with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05397951University of North Carolina, Chapel HillThe Validation Study of Bioelectronics | 2026-11 |
| NCT05760573Rutgers, The State University of New JerseyThe Ready and Healthy for Kindergarten Study | 2026-11-30 |
| NCT07055165University of OklahomaConnect2Care: Prostate Cancer Education and Screenings for African American Men | 2026-12 |
| NCT06684483National Institutes of Health Clinical Center (CC)The Impact of Heavy Alcohol Use on Saliva and Oral Health | 2026-12-01 |
| NCT05619705Johns Hopkins UniversityHealthy for Two-Home Visiting (H42-HV): Health Coaching for Pregnant Women | 2026-12-15 |
Add all 26 to your calendar (.ics) → With an account.
Among the 421 studies in Health Behavior with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Caregiver:
Child:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
CHWs are non-clinical people who provide education, care coordination, and support to families.
Parent-reported Tooth Brushing Frequency
parents will be asked how often the child's teeth are brushed
Time frame: 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.
Time frame: 12-months post-randomization
| Milestone | CHW Arm | Wait-list Control Arm |
|---|---|---|
| Started | 211 | 209 |
| Completed | 175 | 187 |
| Not completed | 36 | 22 |
parents will be asked how often the child's teeth are brushed
| Participants | CHW Arm | Wait-list Control Arm |
|---|---|---|
| Never brush | 1 | 1 |
| Sometimes, but not everyday brush | 12 | 15 |
| Once a day brush | 56 | 49 |
| Twice a day brush | 85 | 105 |
| More than twice a day brush | 21 | 17 |
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.
| score on a scale | CHW Arm | Wait-list Control Arm |
|---|---|---|
| Child Dental Plaque Score | 1.88 ± 0.64 | 1.85 ± 0.66 |
Collected over Adverse events were collected for each participant over a 1 year period, from enrollment through the 1 year data collection.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CHW Arm | 0/211 (0%) | 0/211 (0%) | 0/211 (0%) |
| Wait-list Control Arm | 0/209 (0%) | 0/209 (0%) | 0/209 (0%) |
| Age, Continuous(months) | CHW Arm | Wait-list Control Arm | Total |
|---|---|---|---|
| Mean | 22.4 ± 6.8 | 20.8 ± 7.0 | 21.5 ± 6.9 |
| Sex: Female, Male(Participants) | CHW Arm | Wait-list Control Arm | Total |
|---|---|---|---|
| Female | 104 | 109 | 213 |
| Male | 107 | 100 | 207 |
| Ethnicity (NIH/OMB)(Participants) | CHW Arm | Wait-list Control Arm | Total |
|---|---|---|---|
| Hispanic or Latino | 115 | 111 | 226 |
| Not Hispanic or Latino | 96 | 98 | 194 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | CHW Arm | Wait-list Control Arm | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 92 | 84 | 176 |
| White | 21 | 36 | 57 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 98 | 89 | 187 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Supporting information: Study protocol
Time frame: These details are not fully developed.
Access criteria: These details are not fully developed.
Ran from Jan 2018 to primary completion in Aug 2020, 31 months.
Results were first posted in Dec 2021, 1 year 3 months after primary completion.
Of 568 non-industry interventional studies with no phase under Health Behavior, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 33. This study's 31 months is above that.
Counting every sponsor, half of 586 studies reached it within 15 months; a quarter within 5 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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University of Illinois at Chicago →