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Using Bite Counter for Weight Loss: A One-month Usability Trial to Test the Effectiveness of Using the Bite Counter (Bites)

Primary Purpose

Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Bite Counter tracking

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

18-65 years of age
BMI between 25- 49.9 kg/m2
live in Columbia, South Carolina area
be able to attend all assessment visits
have access to the Internet, a computer, and a smartphone (iPhone, Android, etc.)
have MD consent for participation if currently on blood pressure medications, have issues with dizziness, or have bone or joint issues
be free of an eating disorder as screened by the Eating disorder Screen for Primary care. (If a participant has an eating disorder, they will be referred to their family physician)
no current participation in a weight loss program or taking weight loss medications (although participants may be trying to lose weight on their own)
able to prepare all their own meals (i.e. not living on-campus)

Exclusion Criteria:

major health or psychiatric diseases, drug or alcohol dependency, thyroid conditions, or pregnancy
pregnant (or have been pregnant in the last 6 months), anticipating on becoming pregnant in the next 7 months, or currently breastfeeding o Women who are pregnant should not be pursuing weight loss and should be under the direct care of a physician. Therefore women who are pregnant or who are anticipating they might be pregnant should not participate in this study. If a woman becomes pregnant during the study, she will be advised to consult her care provider and will be dropped from the weight loss study.

Sites / Locations

University of South Carolina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bite Counter tracking

Arm Description

Study participants will be asked to track their energy intake via a wearable device called the Bite Counter. Participants will attend weekly meetings to provide feedback on the Bite Counter.

Outcomes

Primary Outcome Measures

Body Weight (kg)

Assessed with a digital scale accurate to 0.1 kg

Secondary Outcome Measures

Energy intake (kilocalories)

Assessed via 2 unannounced 24-hour dietary recalls

Full Information

NCT ID

NCT02494674

First Posted

July 6, 2015

Last Updated

April 16, 2019

Sponsor

University of South Carolina

1. Study Identification

Unique Protocol Identification Number

NCT02494674

Brief Title

Using Bite Counter for Weight Loss: A One-month Usability Trial to Test the Effectiveness of Using the Bite Counter

Acronym

Bites

Official Title

Using Bite Counter for Weight Loss: A One-month Usability Trial to Test the Effectiveness of Using a Wearable Bite Counter to Assist With Dietary Self-monitoring

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

July 2015 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of South Carolina

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a 1-month study that will examine the use of podcasting and a wearable wrist-worn device to track calorie intake and promote weight loss. A podcast is a digital audio file that can be listened to on portable media players, like iPods, and personal computers. This study will run from July 14, 2015 to August 11, 2015. In this study, you will receive weight loss information delivered via twice weekly podcasts. You will also track each meal you eat by wearing a provided watch-like device.

Detailed Description

This study will last approximately 1 month (about 4 weeks). Participants will need to attend one 1.5-hour orientation meeting, baseline assessment, and training meeting, and then weekly 1-hour meetings for four weeks (5 meetings total). Participants will listen to 2 podcasts per week and will be encouraged to monitor exercise and body weight and track each meal using the provided wearable, wrist worn device. Each of the podcasts will take about 15 - 20 minutes to listen to and so participants should expect to spend 30 - 40 minutes each week listening to podcasts and up to 3 hours completing other study-related activities each week-including attending the weekly meetings-for a total of about 4 hours per week.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bite Counter tracking

Arm Type

Experimental

Arm Description

Study participants will be asked to track their energy intake via a wearable device called the Bite Counter. Participants will attend weekly meetings to provide feedback on the Bite Counter.

Intervention Type

Behavioral

Intervention Name(s)

Bite Counter tracking

Intervention Description

Participants will be asked to use the bite counter to track all meals and provide feedback on using the bite counter for dietary self-monitoring.

Primary Outcome Measure Information:

Title

Body Weight (kg)

Description

Assessed with a digital scale accurate to 0.1 kg

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Energy intake (kilocalories)

Description

Assessed via 2 unannounced 24-hour dietary recalls

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18-65 years of age BMI between 25- 49.9 kg/m2 live in Columbia, South Carolina area be able to attend all assessment visits have access to the Internet, a computer, and a smartphone (iPhone, Android, etc.) have MD consent for participation if currently on blood pressure medications, have issues with dizziness, or have bone or joint issues be free of an eating disorder as screened by the Eating disorder Screen for Primary care. (If a participant has an eating disorder, they will be referred to their family physician) no current participation in a weight loss program or taking weight loss medications (although participants may be trying to lose weight on their own) able to prepare all their own meals (i.e. not living on-campus) Exclusion Criteria: major health or psychiatric diseases, drug or alcohol dependency, thyroid conditions, or pregnancy pregnant (or have been pregnant in the last 6 months), anticipating on becoming pregnant in the next 7 months, or currently breastfeeding o Women who are pregnant should not be pursuing weight loss and should be under the direct care of a physician. Therefore women who are pregnant or who are anticipating they might be pregnant should not participate in this study. If a woman becomes pregnant during the study, she will be advised to consult her care provider and will be dropped from the weight loss study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brie Turner-McGrievy, PhD

Organizational Affiliation

University of South Carolina

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of South Carolina

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29208

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Using Bite Counter for Weight Loss: A One-month Usability Trial to Test the Effectiveness of Using the Bite Counter

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