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临床试验/NCT04977947
NCT04977947已完成不适用

Reducing Health Disparities Through an Adaptive Healthy Eating Program for Underserved Infants in a Home Visiting Program

University of Cincinnati4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年6月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
4
主要终点
Group Differences in Infant BMI

研究概览

简要总结

Infants from underserved and minority backgrounds are at increased risk for obesity and poor feeding and nutrition outcomes, but obesity prevention programs tailored specifically to the needs of these infants are lacking. The current study takes a community-engaged approach to development and delivery of an adaptively tailored obesity prevention program delivered via home visiting to target infant eating and feeding (Healthy Eating for My Infant; HEMI).

详细描述

Poor dietary habits and obesity-risk begin early in infancy. Infants from underserved and minority backgrounds experience disparate rates of poor nutritional outcomes and subsequent health disparities related to obesity. Each infant and their family experiences a unique set of risk factors and barriers to healthy eating. However, obesity prevention programs that are culturally and contextually relevant for underserved families and adapted based on the needs of individual families are lacking. The current study will develop an obesity prevention program, Healthy Eating for My Infant (HEMI), using a community-engaged approach involving community members in development and delivery of the program. HEMI targets healthy infant feeding through six monthly sessions with infants 3-8 months old. The program will be delivered as a supplement to an already existing evidence-based home visiting program, Every Child Succeeds (ECS), serving families with primarily low income and ethnic/racial minority backgrounds.

Development of an adaptive and effective obesity prevention program meeting the needs of underserved infants is critical for addressing health disparities in infant eating and obesity.

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
2 Months 至 9 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Infant enrolled in the Every Child Succeeds (ECS) program
  • Infant age is < 2 months at study recruitment
  • Infant born at > 37 weeks gestation
  • Infant is a singleton
  • Maternal age is > 18 years (in order to consent for child to participate)
  • Mother is fluent in English or Spanish

排除标准

  • Infant has a major medical condition that requires specialized feeding

结局指标

主要结局

Group Differences in Infant BMI

时间窗: The measure of group differences in infant BMI will be completed at post-treatment (when the child is 9 months of age).

Families receiving the program will be compared to infants in control families who receive standard ECS content only to determine which group has a lower proportion of infants with Body Mass Index greater than or equal to the 85th percentile. Anthropometrics were measured in triplicate using a calibrated mobile digital SECA baby scale and portable infant length board. Infants were weighed in a clean diaper without clothes to the nearest 1 gram. All length measurements were performed by two team members. Infant BMI standardized for age and sex was calculated from the WHO 2005 growth standards to obtain BMI percentile. Percentiles under the 5th percentile are considered underweight, percentiles between 5th- 85th percentile are considered healthy weight, percentiles 85th- 95th percentile are considered overweight, and percentiles equal to or greater than the 95th percentile are considered obesity.

次要结局

  • Group Differences in Infant Diet Quality(The measure of infant diet will be completed within 2 weeks of the baseline visit (when the child is 2 months of age) and again within 2 weeks of the post-treatment visit (when the child is 9 months of age).)
  • Group Differences in Infant Diet Diversity(The measure of infant diet will be completed within 2 weeks of the baseline visit (when the child is 2 months of age) and again within 2 weeks of the post-treatment visit (when the child is 9 months of age).)
  • Treatment Acceptability(The measure of feedback on the intervention will be completed at post-treatment (when the child is 9 months of age).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cathy Stough

Assistant Professor

University of Cincinnati

研究点 (4)

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