Clinical trial NCT04556175: Great Beginnings for Healthy Native Smiles: An Early Childhood Caries Prevention Project
Official title: Great Beginnings for Healthy Native Smiles: An Early Childhood Caries Prevention Project
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Early Childhood Caries
Dental Caries
Keywords: child
infant
mothers
pregnant women
dental caries
American Indian, North
motivational interviewing
Lead sponsor: Northern Arizona University
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2020-09-21
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Centralized, computer-based group assignment using permuted blocks.
Primary purpose: PREVENTION

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of decayed, missing and/or filled primary tooth surfaces (dmfs)
timeFrame: 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 outcomes:
measure: Number of decayed, missing or filled primary teeth (dmft)
timeFrame: 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.
measure: Oral health knowledge of mothers/caregivers
timeFrame: 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).
measure: Oral health behavior of mothers/caregivers
timeFrame: Oral health behavior among mothers/caregivers is assessed at Visits 4 (child age 12 months) and 6 (child age 24 months).
measure: Attitudes towards oral health care of mothers/caregivers
timeFrame: 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).
Other outcomes:
Locations:
city: Kykotsmovi
country: United States
facility: The Hopi Tribe, Department of Health and Human Services
state: Arizona
city: Crow Agency
country: United States
facility: Little Big Horn College
state: Montana
Study officials:
affiliation: Northern Arizona University
name: Julie A Baldwin, PhD
role: PRINCIPAL_INVESTIGATOR
References: