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临床试验/NCT02763358
NCT02763358已完成1 期

Assessing the Bite Counter as a Tool for Food Intake Monitoring: Phase II

Medical University of South Carolina2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2016年3月最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
42
试验地点
2
主要终点
Reduction in the numbers of bites per day as displayed on the Bite Counter

研究概览

简要总结

This study is designed to test the usability of the Bite Counter in an attempt to reduce participants' daily bites while also increasing their daily steps.

详细描述

Self-monitoring is an important component of behavioral management of obesity. The Bite Counter is a wrist-worn device which detects the motions characteristic of taking a bite of food or a drink of liquid, to provide the wearer with a cumulative count of bites and sips over the day. In earlier studies the method was shown to accurately count bites across a wide variety of foods, utensils and subject demographics, and to provide an unbiased intake measurement. The proposed work will continue to improve the bite counting method by adapting to varying eating rates, develop a self-managed bite count-based weight loss protocol, and perform an independent test of the protocol. An improved Bite Counter device will also measure activity (steps).

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
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants must be between the ages of 18 and 70 (inclusive)
  • Participants must have a BMI between 27 and 35
  • Participants must have regular and reliable access to a Windows-based computer with an internet connection with USB connectivity
  • Participants must be currently consuming at least 1400 calories per day
  • Participants must demonstrate adequate compliance with using Bite Counter and uploading data during the two-week baseline period

排除标准

  • Participants must have no history of any eating disorder
  • Participants must not have participated in a weight loss program within the month prior to baseline

研究组 & 干预措施

Bites and Steps displayed

Other

All subjects will be assigned to one arm-daily bites and steps displayed on Bite Counter device

干预措施: Bite Counter (Device)

结局指标

主要结局

Reduction in the numbers of bites per day as displayed on the Bite Counter

时间窗: 15 weeks

次要结局

  • Increase in the number of steps per day as displayed on the Bite Counter(15 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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