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

NCT ID: NCT04556175

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-29
• Study Completion Date: 2022-03-01

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).

Conditions

Early Childhood Caries; Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Oral Health

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.

Group Type: EXPERIMENTAL

Oral Health

Intervention Type: BEHAVIORAL

Motivational interviewing for mothers pre-and postpartum; fluoride varnish for infants/children.

Healthy Lifestyle

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.

Group Type: ACTIVE_COMPARATOR

Healthy Lifestyle

Intervention Type: BEHAVIORAL

Didactic maternal and child health educational sessions for mothers pre-and postpartum; fluoride varnish for infants/children.

Interventions

Oral Health

Motivational interviewing for mothers pre-and postpartum; fluoride varnish for infants/children.

Intervention Type: BEHAVIORAL

Healthy Lifestyle

Didactic maternal and child health educational sessions for mothers pre-and postpartum; fluoride varnish for infants/children.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role: collaborator

Northern Arizona University

OTHER

Sponsor Role: lead

Responsible Party

Julie Baldwin

Regents' Professor; Director, Center for Health Equity Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julie A Baldwin, PhD

Role: PRINCIPAL_INVESTIGATOR

Northern Arizona University

Locations

The Hopi Tribe, Department of Health and Human Services

Kykotsmovi, Arizona, United States

Little Big Horn College

Crow Agency, Montana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1U01DE028508-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1396150

Identifier Type: -

Identifier Source: org_study_id