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Completed

NCT Number: NCT02763358

Assessing the Bite Counter

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Medical University of South Carolina-Weight Management Center

Charleston, South Carolina, 29425, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 15 weeks

Secondary outcomes

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

    Time frame: 15 weeks

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • Clemson University

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 5, 2016
Registry last updated
Jul 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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