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

NCT04556175 | Terminated Results DMC

• 2 other identifiers: 13961501U01DE028508-01
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

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.

Conditions

Early Childhood Caries; Dental Caries

Keywords

child; infant; mothers; pregnant women; dental caries; American Indian, North; motivational interviewing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Decayed, Missing or Filled Primary Teeth (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

  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

  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

  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).

Study Arms (2)

Oral Health

EXPERIMENTAL

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

Healthy Lifestyle

ACTIVE COMPARATOR

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

Interventions

Oral Health BEHAVIORAL

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

Oral Health

Healthy Lifestyle BEHAVIORAL

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

Healthy Lifestyle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northern Arizona University: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (2)

The Hopi Tribe, Department of Health and Human Services

Kykotsmovi, Arizona, 86039, United States

Location

Little Big Horn College

Crow Agency, Montana, 59022-0001, United States

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Oral Health

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Health; Population Characteristics

Results Point of Contact

• Title: Dr Julie Baldwin
• Organization: Northern Arizona University

Julie.Baldwin@nau.edu

928-523-6566

Study Officials

• Julie A Baldwin, PhD

  Northern Arizona University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Regents' Professor; Director, Center for Health Equity Research

Model Details: Centralized, computer-based group assignment using permuted blocks.

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 21, 2020
• Study Start: March 29, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: August 29, 2025
• Results First Posted: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)