Great Beginnings for Healthy Native Smiles: An Early Childhood Caries Prevention Project
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- Number of Decayed, Missing and/or Filled Primary Tooth Surfaces (Dmfs)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •• 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
结局指标
主要结局
Number of Decayed, Missing and/or Filled Primary Tooth Surfaces (Dmfs)
时间窗: 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.
次要结局
- 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).)
- 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.)
- 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).)
研究者
Julie Baldwin
Regents' Professor; Director, Center for Health Equity Research
Northern Arizona University