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临床试验/NCT05217524
NCT05217524已完成不适用

Evaluation of the Accuracy of a Novel Smartwatch Bioimpedance Device for Assessment of Body Composition

Pennington Biomedical Research Center1 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
1
主要终点
%body fat

研究概览

简要总结

The aim of this study is to acquire impedance measurements of the adult human body with a novel bioimpedance device housed inside a watch case and to compare derived estimates of body composition measured by dual-energy x-ray absorptiometry (DXA) and other bioimpedance analysis (BIA) systems.

详细描述

Aims:

The study hypothesis will be tested as follows. Each subject will complete novel BIA, DXA, anthropometric, and other BIA studies at PBRC and the University of Hawaii Cancer Center. The acquired data will then be used to accomplish the specific aims:

  1. Identify the associations of body composition acquired by the novel BIA devices with those estimated by DXA and other BIA systems.
  2. Describe the precision and accuracy of the novel BIA-derived body composition estimates.

Subjects and Design:

We will recruit a stratified sample of 100 participants recruited from the Baton Rouge metropolitan area for this study over a span of 6 months. Participants will be further subdivided into cohorts based on gender, age, and BMI.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • • Being either male or female
  • Being from 18 to 80 years of age
  • Having a body weight of less than 440 pounds
  • Being willing to comply with the study procedures
  • Able climb 10 steps without difficulty and able to perform activities of daily living without difficulty (self-reported)
  • Exclusion Criteria• Being pregnant or attempting to become pregnant
  • Having medical implants such as a pacemaker or metal joint replacements
  • Having a body weight greater than 440 pounds

排除标准

  • 未提供

结局指标

主要结局

%body fat

时间窗: 6 months

Referenced against DXA

次要结局

未报告次要终点

研究者

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

Steven Heymsfield

Professor

Pennington Biomedical Research Center

研究点 (1)

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