Obesity Clinical Trial
— BitesOfficial 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
| NCT number | NCT02494674 |
| Other study ID # | Pro00036795 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | July 2015 |
| Est. completion date | November 2015 |
| Verified date | April 2019 |
| Source | University of South Carolina |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 12 |
| Est. completion date | November 2015 |
| Est. primary completion date | August 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of South Carolina | Columbia | South Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| University of South Carolina |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Body Weight (kg) | Assessed with a digital scale accurate to 0.1 kg | 4 weeks | |
| Secondary | Energy intake (kilocalories) | Assessed via 2 unannounced 24-hour dietary recalls | 4 weeks |
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