Great Beginnings for Healthy Native Smiles: An Early Childhood Caries Prevention Project

Study Overview
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Brief Summary
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The purpose of this study is to determine whether a bundled best practices oral health intervention utilizing motivational interviewing versus a didactic maternal and child healthy lifestyle intervention will reduce childrens' decayed, missing and/or filled primary tooth surfaces (dmfs) measured over a 2-3 year period.

Detailed Description
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Early Childhood Caries (ECC) is the most common chronic disease among children. American Indian (AI) children are 4 times more likely to have untreated dental decay than white children. This is a four year parallel group randomized clinical trial evaluating the impact of a bundled best practices oral health intervention on early childhood caries in American Indian children as indicated by the number of decayed, missing and/or filled primary tooth surfaces (dmfs). The intervention is delivered during pregnancy and through child age 24-36 months. The bundled best practices include motivational interviewing with mothers and fluoride varnish applied to the child's teeth. The oral health intervention also includes Tribe-specific individual, social and health needs identified in an earlier formative assessment. The oral health intervention group (n=175 mother-child dyads) will be compared to a group (n=175 mother-child dyads) receiving a standard prenatal/postnatal healthy lifestyle intervention. This comparison Healthy Lifestyle intervention is designed to improve maternal/child health knowledge and also includes Tribe-specific individual, social and health needs identified in an earlier formative assessment. Children in both groups receive some fluoride varnish. All study treatments will be delivered by Community Health Representatives from two Tribal communities in the Western U.S. Children and caregivers will be followed until up to 3 years of age. The primary outcome measure is the average number of decayed, missing and/or filled primary tooth surfaces (dmfs) at the last follow up (24 months for the late enrollment cohort; 30-36 months of age for the early enrollment cohort). Secondary outcomes include 1) the average number of decayed, missing and/or filled primary teeth (dmft) at the last follow up; survey based measures of 2) oral health knowledge; 3) oral health behavior; 4) attitudes towards oral health care; and 5) knowledge of maternal health and child development (e.g., pregnancy related nutrition; breastfeeding; prenatal health).

Official Title
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Great Beginnings for Healthy Native Smiles: An Early Childhood Caries Prevention Project

Conditions
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Early Childhood Caries, Dental Caries

Intervention / Treatment
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* Behavioral: Oral Health
* Behavioral: Healthy Lifestyle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide signed and dated informed consent form Be willing and able to follow study procedures and instructions and be available for the duration of the study Be at least 18 years of age (mother) Be American Indian or giving birth to an AI child, and living on or near (approximately 100 miles) the Hopi or Crow nations. American Indian status is self-identified-no tribal enrollment verification will be required. Be currently pregnant-preferably in month 4 of pregnancy at enrollment but mothers are eligible when 3-7 months pregnant. Be willing to participate until the child is age 3 Mothers of twins will be included, but only one child will be enrolled as the study child. Exclusion Criteria: • Anything that would place the individual at increased risk or preclude the individual's full compliance with, or completion of, the study. Enrolled in other community health interventions that incorporate oral health intervention. A member of the Northern Cheyenne Tribe Living on the Navajo Nation and a member of the Navajo Tribe

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Centralized, computer-based group assignment using permuted blocks.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Health<br>Motivational interviewing sessions will involve in-person visits by Community Health Workers focused on the mitigation of behavioral risk factors for early childhood caries, with two sessions provided before childbirth and four more sessions at 6, 12, 18 and 24 months after childbirth. Children receive up to 4 fluoride varnish applications during the study. Early cohort of enrollees will be followed up in a 7th visit solely for oral health assessment. | Behavioral: Oral Health<br>* Motivational interviewing for mothers pre-and postpartum; fluoride varnish for infants/children.<br>|
| Active Comparator: Healthy Lifestyle<br>Didactic educational sessions delivered in-person by Community Health Workers cover nutrition and diet, physical activity, breastfeeding/formula feeding, substance use, mental/emotional health, personal and family goals, prenatal/postpartum health care access, labor and delivery, family support, infant/child care, oral health, and development milestones. Children receive up to 2 fluoride varnish applications during the study. Early cohort enrollees will be followed up in a 7th visit solely for oral health assessment. | Behavioral: Healthy Lifestyle<br>* Didactic maternal and child health educational sessions for mothers pre-and postpartum; fluoride varnish for infants/children.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of decayed, missing and/or filled primary tooth surfaces (dmfs) | For dmfs, there are five surfaces counted on the posterior teeth: facial, lingual, mesial, distal, and occlusal. There are four surfaces counted on anterior teeth: facial, lingual, mesial, and distal. The total tooth count is 20 (8 posterior and 12 anterior) equaling a total of 88 surfaces possible. Each tooth surface will be scored using one of the following mutually exclusive categories; cavitated decayed lesion; filled surface (amalgam); filled surface (non-amalgam); sealed surface; unerupted surface; unable to score. The primary outcome measure is the count of all surfaces scored as cavitated decayed lesion/filled surface/missing due to caries for each individual. | The outcome will be assessed through study completion, child ages 30-36 months for early cohort; 24 months for late cohort. Differential follow up is planned but only the last assessment time point is the primary outcome measure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of decayed, missing or filled primary teeth (dmft) | This is a count of the number of teeth with one or more decayed, missing or filled surfaces. This is calculated by counting teeth, rather than tooth surfaces, using the primary outcome assessment (dmfs). If no teeth have been filled or are missing due to disease this outcome is called dt rather than dmft. | The outcome will be assessed through study completion, child ages 30-36 months for early cohort; 24 months for late cohort. Differential follow up is planned but only the last assessment time point is the secondary outcome measure. | 
| Oral health knowledge of mothers/caregivers | Percentage of correct responses to 18 knowledge questions based upon the Basic Research Factors Questionnaire. There are six true/false questions, 8 Likert-type judgements of whether certain behaviors are good for a child's teeth, and 4 multiple choice questions regarding infant/child oral health care. | Oral health knowledge among mothers/caregivers is assessed at Visits 1 (4-7 months pregnant), 4 (child age 12 months) and 6 (child age 24 months). | 
| Oral health behavior of mothers/caregivers | Percentage of correct responses to 12 questions regarding oral health behavior. Eleven are based upon the Basic Research Factors Questionnaire (Wilson et al. Pediatr Dent 2016;38:47-54) and one is based on study-specific question formative assessments. Items include three questions regarding dental health care utilization, seven questions regarding parental involvement in oral health care for self and child and two questions regarding consumption of sweets/sugar. | Oral health behavior among mothers/caregivers is assessed at Visits 4 (child age 12 months) and 6 (child age 24 months). | 
| Attitudes towards oral health care of mothers/caregivers | Sum of Likert-type ratings for 14 items. Scores range from 14 (lowest) to 70 (highest) with higher scores representing more favorable attitudes towards child oral health care. | Attitudes towards oral health among mothers/caregivers is assessed at Visits 1 (4-7 months pregnant), 4 (child age 12 months) and 6 (child age 24 months). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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child, infant, mothers, pregnant women, dental caries, American Indian, North, motivational interviewing