Assessing the Bite Counter

NCT02763358 | Completed Phase 1

• 1 other identifier: 00043670
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Loss

Keywords

obesity; weight loss

Outcome Measures

Primary Outcomes (1)

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

  15 weeks

Secondary Outcomes (1)

• Increase in the number of steps per day as displayed on the Bite Counter

  15 weeks

Study Arms (1)

Bites and Steps displayed

OTHER

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

Device: Bite Counter

Interventions

Bite Counter 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.

Bites and Steps displayed

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Clemson University: collaborator

Study Sites (1)

Medical University of South Carolina-Weight Management Center

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Weight Loss; Obesity

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Patrick O'Neil, PhD

  Medical University of South Caolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2016
• First Posted: May 5, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: July 30, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)