Assessing the Bite Counter

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02763358
• Other study ID #: 00043670
• Status: Completed
• Phase: Phase 1
• Start date: March 2016
• Est. completion date: March 2017

Study information

• Verified date: June 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Weight Loss

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina-Weight Management Center	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	Clemson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in the numbers of bites per day as displayed on the Bite Counter		15 weeks
Secondary	Increase in the number of steps per day as displayed on the Bite Counter		15 weeks