Dental Caries in Children, Health Behavior, Healthcare Disparities
Conditions
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.
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.
Interventions
BEHAVIORALCommunity Health Worker (CHW) services
CHWs are non-clinical people who provide education, care coordination, and support to families.
Sponsors
National Institute of Dental and Craniofacial Research (NIDCR)
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
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.
Intervention model description
cluster-randomized two arm trial with wait list control
Eligibility
Sex/Gender
ALL
Age
6 Months to 36 Months
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parent-reported Tooth Brushing Frequency | 12-months post-randomization | parents will be asked how often the child's teeth are brushed |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Community Health Worker (CHW) services: CHWs are non-clinical people who provide education, care coordination, and support to families. | 211 |
| 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. | 209 |
| Total | 420 |
Baseline characteristics
| Characteristic | Wait-list Control Arm | Total | CHW Arm |
|---|---|---|---|
| Age, Continuous | 20.8 months STANDARD_DEVIATION 7 | 21.5 months STANDARD_DEVIATION 6.9 | 22.4 months STANDARD_DEVIATION 6.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 111 Participants | 226 Participants | 115 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 98 Participants | 194 Participants | 96 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 84 Participants | 176 Participants | 92 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 89 Participants | 187 Participants | 98 Participants |
| Race (NIH/OMB) White | 36 Participants | 57 Participants | 21 Participants |
| Sex: Female, Male Female | 109 Participants | 213 Participants | 104 Participants |
| Sex: Female, Male Male | 100 Participants | 207 Participants | 107 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 211 | 0 / 209 |
| other Total, other adverse events | 0 / 211 | 0 / 209 |
| serious Total, serious adverse events | 0 / 211 | 0 / 209 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CHW Arm | Child Dental Plaque Score | 1.88 score on a scale | Standard Deviation 0.64 |
| Wait-list Control Arm | Child Dental Plaque Score | 1.85 score on a scale | Standard Deviation 0.66 |
Primary
Parent-reported Tooth Brushing Frequency
parents will be asked how often the child's teeth are brushed
Time frame: 12-months post-randomization
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CHW Arm | Parent-reported Tooth Brushing Frequency | Sometimes, but not everyday brush | 12 Participants |
| CHW Arm | Parent-reported Tooth Brushing Frequency | Twice a day brush | 85 Participants |
| CHW Arm | Parent-reported Tooth Brushing Frequency | Once a day brush | 56 Participants |
| CHW Arm | Parent-reported Tooth Brushing Frequency | More than twice a day brush | 21 Participants |
| CHW Arm | Parent-reported Tooth Brushing Frequency | Never brush | 1 Participants |
| Wait-list Control Arm | Parent-reported Tooth Brushing Frequency | More than twice a day brush | 17 Participants |
| Wait-list Control Arm | Parent-reported Tooth Brushing Frequency | Never brush | 1 Participants |
| Wait-list Control Arm | Parent-reported Tooth Brushing Frequency | Sometimes, but not everyday brush | 15 Participants |
| Wait-list Control Arm | Parent-reported Tooth Brushing Frequency | Once a day brush | 49 Participants |
| Wait-list Control Arm | Parent-reported Tooth Brushing Frequency | Twice a day brush | 105 Participants |