- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04556175
Great Beginnings for Healthy Native Smiles: An Early Childhood Caries Prevention Project
July 11, 2022 updated by: Julie Baldwin, Northern Arizona University
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Arizona
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Kykotsmovi, Arizona, United States, 86039
- The Hopi Tribe, Department of Health and Human Services
-
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Montana
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Crow Agency, Montana, United States, 59022-0001
- Little Big Horn College
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Motivational interviewing for mothers pre-and postpartum; fluoride varnish for infants/children.
|
Active Comparator: 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.
|
Didactic maternal and child health educational sessions for mothers pre-and postpartum; fluoride varnish for infants/children.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of decayed, missing and/or filled primary tooth surfaces (dmfs)
Time Frame: 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.
|
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.
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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)
Time Frame: 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.
|
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
Time Frame: 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).
|
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.
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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).
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Oral health behavior of mothers/caregivers
Time Frame: Oral health behavior among mothers/caregivers is assessed at Visits 4 (child age 12 months) and 6 (child age 24 months).
|
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.
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Oral health behavior among mothers/caregivers is assessed at Visits 4 (child age 12 months) and 6 (child age 24 months).
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Attitudes towards oral health care of mothers/caregivers
Time Frame: 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).
|
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.
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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).
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Julie A Baldwin, PhD, Northern Arizona University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 29, 2021
Primary Completion (Actual)
March 1, 2022
Study Completion (Actual)
March 1, 2022
Study Registration Dates
First Submitted
September 1, 2020
First Submitted That Met QC Criteria
September 14, 2020
First Posted (Actual)
September 21, 2020
Study Record Updates
Last Update Posted (Actual)
July 13, 2022
Last Update Submitted That Met QC Criteria
July 11, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1396150
- 1U01DE028508-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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