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临床试验/NCT05587816
NCT05587816已完成不适用

Evaluating the Validity of a Novel Tool to Measure Children's Food Intake and Improve Health

Pennington Biomedical Research Center1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2022年10月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
1
主要终点
Estimation of energy intake (kcal) by children using the PortionSize app

研究概览

简要总结

The purpose of this study is to assess the validity of the PortionSize™ app to quantify children's own dietary intake and children's intake by parents or caregivers.

详细描述

The investigators will recruit 40 dyads (40 children aged 7-12 years old and 40 parents or caregivers) using a convenience sample for this pilot study. Children and their parents or caregivers will be trained to use the PortionSize app at Pennington Biomedical Research Center (PBRC). Children will use the PortionSize app and estimate food intake from pre-weighed meals (simulated meals) at PBRC clinic. Children will not consume the simulated meals. Children's parents or caregivers will also use the PortionSize app and estimate the food intake of their children (at least one meal and a snack each day) for two consecutive days at home.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
7 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Male or female
  • Children (7-12 years) and their parents or caregivers (18-62 years)
  • Parents who have Willingness to use the PortionSize app to estimate the intake of their child food intake (normal/regular diet) from at least a snack and a meal of child for two consecutive days
  • Have iPhone (version 6 or above) and an operable Apple ID, password, and email address, and able to use iPhone

排除标准

  • Any condition or circumstance that could impede study completion
  • Child who is a very choosy eater or has a very limited food choice

研究组 & 干预措施

Experimental

Experimental
  • Training and use of the PortionSize app by children and parents or caregivers
  • Using the PortionSize app at the clinic of Pennington Biomedical Research Center and at home (free-living condition)
  • Rating the satisfaction of using the PortionSize app

干预措施: Validation of the PortionSize app (Device)

结局指标

主要结局

Estimation of energy intake (kcal) by children using the PortionSize app

时间窗: One study visit of ~ 2.5 hours

Percent mean error and Bland-Altman analysis will be performed to determine errors in estimations of energy intake from the PortionSize app compared to estimations of energy intake from the weighed meals (the criterion measure).

Estimation of energy intake (kcal) by parents or caregivers using the PortionSize app

时间窗: Parents or caregivers will assess food intake of their child (at least one meal and a snack) for two consecutive days at home

Percent mean error and Bland-Altman analysis will be performed to assess errors in estimating energy intake using the PortionSize app compared to estimations of energy measured by expert raters via food photography analysis.

Estimation of intake of food group servings (fruit, vegetable, grain, protein, and dairy) by children using the PortionSize app

时间窗: One study visit of ~ 2.5 hours

Percent mean error and Bland-Altman analysis will be performed to determine errors in estimations of intake of food group servings from the PortionSize app compared to estimations of food group servings from the weighed meals (the criterion measure).

Estimation of intake of food group servings (fruit, vegetable, grain, protein, and dairy) by parents or caregivers using the PortionSize app

时间窗: Parents or caregivers will assess food intake of their child (at least one meal and a snack) for two consecutive days at home

Percent mean error and Bland-Altman analysis will be performed to assess errors in intake of food group servings using the PortionSize app compared to estimations of food group servings measured by expert raters via food photography analysis.

Estimation of Energy Intake (kcal) by Children Using the PortionSize App

时间窗: One study visit of ~ 2.5 hours

Percent mean error and Bland-Altman analysis will be performed to determine errors in estimations of energy intake from the PortionSize app compared to estimations of energy intake from the weighed meals (the criterion measure).

Estimation of Intake of Food Group Servings (Fruit) by Children Using the PortionSize App

时间窗: One study visit of ~ 2.5 hours

Percent mean error and Bland-Altman analysis will be performed to determine errors in estimations of intake of food group servings from the PortionSize app compared to estimations of food group servings from the weighed meals (the criterion measure).

Estimation of Energy Intake (kcal/Day) by Parents or Caregivers Using the PortionSize App

时间窗: Parents or caregivers will assess food intake of their child (at least one meal and a snack) for two consecutive days at home

Percent mean error and Bland-Altman analysis will be performed to assess errors in estimating energy intake using the PortionSize app compared to estimations of energy measured by expert raters via food photography analysis.

Estimation of Intake of Food Group Servings (Fruit) by Parents or Caregivers Using the PortionSize App

时间窗: Parents or caregivers will assess food intake of their child (at least one meal and a snack) for two consecutive days at home

Percent mean error and Bland-Altman analysis will be performed to assess errors in intake of food group servings using the PortionSize app compared to estimations of food group servings measured by expert raters via food photography analysis.

次要结局

  • User satisfaction of the PortionSize app for recording food intake by children(One study visit of ~ 2.5 hours)
  • User satisfaction of the PortionSize app for recording food intake by parents or caregivers(Parents or caregivers will assess food intake of their child (at least one meal and a snack) for two consecutive days at home)
  • User Satisfaction of the PortionSize App for Recording Food Intake by Children(One study visit of ~ 2.5 hours)
  • User Satisfaction of the PortionSize App for Recording Food Intake by Parents or Caregivers(Parents or caregivers will assess food intake of their child (at least one meal and a snack) for two consecutive days at home)

研究者

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

Hanim Diktas

Principal Investigator

Pennington Biomedical Research Center

研究点 (1)

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