- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02494674
Using Bite Counter for Weight Loss: A One-month Usability Trial to Test the Effectiveness of Using the Bite Counter (Bites)
April 16, 2019 updated by: Brie Turner-McGrievy, University of South Carolina
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
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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South Carolina
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Columbia, South Carolina, United States, 29208
- University of South Carolina
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Bite Counter tracking
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Weight (kg)
Time Frame: 4 weeks
|
Assessed with a digital scale accurate to 0.1 kg
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Energy intake (kilocalories)
Time Frame: 4 weeks
|
Assessed via 2 unannounced 24-hour dietary recalls
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Brie Turner-McGrievy, PhD, University of South Carolina
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2015
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
November 1, 2015
Study Registration Dates
First Submitted
July 6, 2015
First Submitted That Met QC Criteria
July 7, 2015
First Posted (Estimate)
July 10, 2015
Study Record Updates
Last Update Posted (Actual)
April 18, 2019
Last Update Submitted That Met QC Criteria
April 16, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00036795
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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