Back to resultsAssessing the Bite Counter
Primary Purpose
Weight Loss
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Bite Counter
Sponsored by
About this trial
This is an interventional other trial for Weight Loss focused on measuring obesity, weight loss
Eligibility Criteria
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
Sites / Locations
- Medical University of South Carolina-Weight Management Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Bites and Steps displayed
Arm Description
All subjects will be assigned to one arm-daily bites and steps displayed on Bite Counter device
Outcomes
Primary Outcome Measures
Reduction in the numbers of bites per day as displayed on the Bite Counter
Secondary Outcome Measures
Increase in the number of steps per day as displayed on the Bite Counter
Full Information
NCT ID
NCT02763358
First Posted
April 8, 2016
Last Updated
July 26, 2018
Sponsor
Medical University of South Carolina
Collaborators
Clemson University
1. Study Identification
Unique Protocol Identification Number
NCT02763358
Brief Title
Assessing the Bite Counter
Official Title
Assessing the Bite Counter as a Tool for Food Intake Monitoring: Phase II
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
Collaborators
Clemson University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss
Keywords
obesity, weight loss
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bites and Steps displayed
Arm Type
Other
Arm Description
All subjects will be assigned to one arm-daily bites and steps displayed on Bite Counter device
Intervention Type
Device
Intervention Name(s)
Bite Counter
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction in the numbers of bites per day as displayed on the Bite Counter
Time Frame
15 weeks
Secondary Outcome Measure Information:
Title
Increase in the number of steps per day as displayed on the Bite Counter
Time Frame
15 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick O'Neil, PhD
Organizational Affiliation
Medical University of South Caolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina-Weight Management Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assessing the Bite Counter
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