Assessing the Bite Counter

NCT ID: NCT02763358

Last Updated: 2018-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-03-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Weight Loss

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Bites and Steps displayed

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

Group Type OTHER

Bite Counter

Intervention Type DEVICE

This study is a 15-week assessment of the possible utility of a wrist-worn device, the Bite Counter, in assisting the weight loss behavior change efforts of overweight and obese individuals. The Bite Counter tracks and analyzes wrist motions to identify those associated with taking bites of food and drinking beverages. It also has a step-counter feature. This study is designed to determine if using the Bite Counter with specific goals to reduce the numbers of bites and increase the numbers of steps will result in those changes.

Interventions

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Bite Counter

This study is a 15-week assessment of the possible utility of a wrist-worn device, the Bite Counter, in assisting the weight loss behavior change efforts of overweight and obese individuals. The Bite Counter tracks and analyzes wrist motions to identify those associated with taking bites of food and drinking beverages. It also has a step-counter feature. This study is designed to determine if using the Bite Counter with specific goals to reduce the numbers of bites and increase the numbers of steps will result in those changes.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Clemson University

OTHER

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick O'Neil, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Caolina

Locations

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Medical University of South Carolina-Weight Management Center

Charleston, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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00043670

Identifier Type: -

Identifier Source: org_study_id

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