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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Bite Counter tracking


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bite Counter tracking<br>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. | Behavioral: Bite Counter tracking<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Weight (kg) | Assessed with a digital scale accurate to 0.1 kg | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy intake (kilocalories) | Assessed via 2 unannounced 24-hour dietary recalls | 4 weeks |