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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date April 2019
Source University of South Carolina
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Bite Counter tracking
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.

Locations

Country Name City State
United States University of South Carolina Columbia South Carolina

Sponsors (1)

Lead Sponsor Collaborator
University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

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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