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临床试验/NCT05424471
NCT05424471已完成不适用

Preventing Early Childhood Obesity, Part 1: Family Spirit Nurture, 3-9 Months, Long-term Follow-up

Johns Hopkins Bloomberg School of Public Health2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2021年5月1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
110
试验地点
2
主要终点
Group differences in sugar sweetened beverage (SSB) consumption & water intake.

研究概览

简要总结

This study extends follow up on of Native American (NA) mothers and their children (now age 3-5 years) enrolled in the 1:1 randomized controlled trial of the Family Spirit Nurture (FSN) intervention designed to prevent early childhood obesity (PECO 1). The investigators will examine whether positive FSN impacts on sugar sweetened beverage (SSB) consumption and healthy growth in the first year of life were sustained. The investigators will also examine the effects of the emergency COVID-19 water solutions on water insecurity, early childhood SSB consumption, and growth, and explore how COVID-19 affected child feeding patterns and weight status either through changes in maternal mental health or household food access.

详细描述

Primary Aims

Aim 1. Determine the longer-term effectiveness of the brief FSN intervention on reducing SSB consumption, increasing water intake, and promoting healthy growth status up to 5 years of age.

Aim 2. Examine the impact of point-of-use (POU) water filters, employed as COVID-19 emergency water response efforts, on water insecurity, children's water intake and SSB consumption with or without previous FSN intervention. Positive findings would provide leverage to promote water solutions and water equity.

Secondary Aims

Secondary Aim 1. Determine whether providing a booster lesson at 4 years of age targeting age appropriate parental feeding practices, snack routines, avoidance of SSBs and increased water intake impacts SSB consumption and water intake between 4 and 4.5 years of age and child growth between 4 and 5 years of age.

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
None

入排标准

年龄范围
13 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Mother/child dyads who enrolled, participated in/completed the initial PECO 1 study (followed mother/infant dyads through 12 months of age).
  • Willingness to fully participate.

排除标准

  • Inability to participate in full intervention or evaluation (e.g., planned move, etc.)

结局指标

主要结局

Group differences in sugar sweetened beverage (SSB) consumption & water intake.

时间窗: 3 months to 5 years of age

Mothers were asked about SSB initiation and frequency among infants between 3 months and 12 months of age in the Preventing Early Childhood Obesity, Part 1: Family Spirit Nurture, 3-9 Months study using an an adapted version of the Pre-School-Aged Beverage Intake Questionnaire (BEVQ-15). We will continue to use the age appropriate Pre-School-Aged BEVQ-15 to assess child's SSB consumption and water intake between 4 and 5 years of age. This data will be examined for between group differences in SSB consumption and water intake through 5 years of age.

Examine whether point-of-use (POU) water filters impact water security, and/or moderate intervention impact on water intake and SSB consumption.

时间窗: 3 to 5 years of age

Examine the impact of point-of-use (POU) water filters, employed as COVID-19 emergency water response efforts, on water insecurity. Examine study group differences in water intake and SSB consumption with and without POU water filters.

Group differences in children's mean BMI z-scores over time as assessed through child weight and length/height measurements through 5 years of age.

时间窗: Birth to 5 years of age

Child weight (to the nearest ounce) and recumbent length/height (to the nearest 1/8 inch) will be extracted through medical chart review. Measurements will be taken by healthcare providers. Measurements will be used to calculate BMI z-scores using age- and sex-specific World Health Organization (WHO) Child Growth Standards.

次要结局

  • Between study group differences, post booster lesson, in age appropriate parental feeding practices, snack routines, avoidance of SSBs and increased water intake.(Up to 5 years of age)
  • Within study group comparison of pre-/during- COVID-19 child feeding practices, snack routines, SSB consumption and water intake and examination of associations with maternal depression and anxiety, and changes in food access.(5 years postpartum)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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