ObesityBitesNCT02494674
Using Bite Counter for Weight Loss: A One-month Usability Trial to Test the Effectiveness of Using the Bite Counter
A study testing Bite Counter tracking in people with Obesity, run by University of South Carolina at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Bite Counter tracking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29208
About this study
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
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Bite Counter tracking
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bite Counter trackingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Bite Counter tracking | Experimental | 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. Receives: Behavioral: Bite Counter tracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight (kg)
Assessed with a digital scale accurate to 0.1 kg
Measured: 4 weeks
Secondary outcomes (1)
Energy intake (kilocalories)
Assessed via 2 unannounced 24-hour dietary recalls
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionAug 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brie Turner-McGrievy, University of South Carolina
- Investigators
- Brie Turner-McGrievy, PhD, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494674
- Sponsor's protocol ID
- Pro00036795
- Acronym
- Bites
- Status last verified
- Apr 2019
- First submitted
- 6 Jul 2015
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02494674
- Acronym / sponsor ID
- Bites / Pro00036795
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 10 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bite Counter tracking | Experimental | Behavioral: Bite Counter trackingStudy 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bite Counter trackingParticipants will be asked to use the bite counter to track all meals and provide feedback on using the bite counter for dietary self-monitoring. | Behavioural | Bite Counter tracking |
Primary outcome
Body Weight (kg)
Time frame: 4 weeks
Assessed with a digital scale accurate to 0.1 kg
1 secondary outcome
Energy intake (kilocalories)
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brie Turner-McGrievy, PhD principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bite Counter tracking in people with Obesity, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight (kg) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.