N/A
N=420
Coordinated Oral Health Promotion (CO-OP) Chicago
Dental Caries in Children · Health Behavior · Healthcare Disparities
Bottom Line
View on ClinicalTrials.gov: NCT03397589 ↗Enrolled (actual)
420
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcome: Primary: Parent-reported Tooth Brushing Frequency — 1; 1; 12; 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Community Health Worker (CHW) services (Behavioral)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Illinois at Chicago
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Parent-reported Tooth Brushing Frequency |
1; 1; 12; 15; 56; 49 | — |
| PRIMARY Child Dental Plaque Score |
1.88; 1.85 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03397589). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.