ObesityDIETMobileNCT02632461
Dietary Intervention Examining Tracking With Mobile Devices
A study testing Podcasts, Mobile Diet Application and Bite Counter in people with Obesity, run by University of South Carolina at 1 site in United States.
Trial summary
The purpose of the study is to test the effectiveness of two different weight loss interventions. Both of these interventions will provide weight loss information through twice weekly audio podcasts. 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?
- Podcasts, Mobile Diet Application and Bite Counter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Sep 2016
- 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
- Must be between 18-65 years old
- Own and use a smartphone and/or a tablet with a data plan
- BMI must be between 25-49.9 kg/m2
- Must be willing to reduce caloric intake and increase physical activity
- Not currently participating in a weight loss study in a weight loss study that involved podcasts
Who cannot join
- Over the age of 65 years old
- Currently participating in a weight loss program
- Has lost more than 10 pounds in the past 6 months
- Diagnosed with stroke or heart attack
- Diagnosed with diabetes that is controlled using medication
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: The Dietary Intervention Examining Tracking With Mobile Devices Study
The purpose of the study is to test the effectiveness of two different weight loss interventions. Both of these interventions will provide weight loss information through twice weekly audio podcasts. In addition to the podcasts, participants will be asked to track their diet using either a wearable device on their wrist or through an app on their smartphone.
Read the detailed description
This study will last approximately 6 months. Participants will attend one 1-hour orientation meeting at the beginning of the study and a 2-hour baseline assessment and training meeting. Additional assessments will be conducted at 3 months and 6 months. Weekly questionnaires will be administered. Everyone in the study will be asked to listen to 2 podcasts per week. 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. Participants will also be randomized to either track diet with an app on their smartphone or using a device they wear on their wrist. Each week, participants will be sent an email as a reminder on how to use their diet tracking device. They will also be encouraged to monitor their exercise and body weight.
- Conditions
- Obesity
- Being tested
- Podcasts, Mobile Diet Application, Bite Counter
- Keywords
- Diet, Weight Loss, Tracking, Calories
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PodcastsBehavioural
Participants will receive twice weekly podcasts that will cover topics related to weight loss.
Mobile Diet ApplicationBehavioural
Participants will use a mobile application on their smartphone to track their diet.
Bite CounterBehavioural
Participants will use a wrist-worn Bite Counter to track the number of bites in their diet per day.
| Study group | Role | What they receive |
|---|---|---|
| Podcast (+Bite Counter) | Experimental | Participants in this group will receive podcasts twice weekly in conjunction with using a wearable wrist device called a Bite Counter. The Bite Counter tracks the number of bites/calories per bite. (Podcasts plus Bite Counter) Receives: Behavioral: Podcasts; Behavioral: Bite Counter |
| Podcast (+Mobile App) | Active comparator | Participants in this group will receive podcasts twice weekly in conjunction with using a mobile application to track their diet. (Podcasts plus Mobile Diet Application) Receives: Behavioral: Podcasts; Behavioral: Mobile Diet Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight as assessed by digital scale
Change in body weight from baseline to 6 months as assessed by digital scale.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 81 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, Principal investigator, University of South Carolina School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02632461
- Sponsor's protocol ID
- Pro00049756
- Acronym
- DIETMobile
- Status last verified
- Apr 2019
- First submitted
- 14 Dec 2015
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Turner-McGrievy GM, Dunn CG, Wilcox S, Boutte AK, Hutto B, Hoover A, Muth E. Defining Adherence to Mobile Dietary Self-Monitoring and Assessing Tracking Over Time: Tracking at Least Two Eating Occasions per Day Is Best Marker of Adherence within Two Different Mobile Health Randomized Weight Loss Interventions. J Acad Nutr Diet. 2019 Sep;119(9):1516-1524. doi: 10.1016/j.jand.2019.03.012. Epub 2019 May 30.
PubMed 31155473Turner-McGrievy GM, Wilcox S, Boutte A, Hutto BE, Singletary C, Muth ER, Hoover AW. The Dietary Intervention to Enhance Tracking with Mobile Devices (DIET Mobile) Study: A 6-Month Randomized Weight Loss Trial. Obesity (Silver Spring). 2017 Aug;25(8):1336-1342. doi: 10.1002/oby.21889. Epub 2017 Jun 10.
PubMed 28600833
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
- The Dietary Intervention Examining Tracking With Mobile Devices Study
- ClinicalTrials.gov ID
- NCT02632461
- Acronym / sponsor ID
- DIETMobile / Pro00049756
- Conditions
- Obesity
- Keywords
- Diet, Weight Loss, Tracking, Calories
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 16 Dec 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.
The purpose of the study is to test the effectiveness of two different weight loss interventions. Both of these interventions will provide weight loss information through twice weekly audio podcasts. In addition to the podcasts, participants will be asked to track their diet using either a wearable device on their wrist or through an app on their smartphone.
Detailed description
This study will last approximately 6 months. Participants will attend one 1-hour orientation meeting at the beginning of the study and a 2-hour baseline assessment and training meeting. Additional assessments will be conducted at 3 months and 6 months. Weekly questionnaires will be administered. Everyone in the study will be asked to listen to 2 podcasts per week. 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. Participants will also be randomized to either track diet with an app on their smartphone or using a device they wear on their wrist. Each week, participants will be sent an email as a reminder on how to use their diet tracking device. They will also be encouraged to monitor their exercise and body weight.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Podcast (+Bite Counter) | Experimental | Behavioral: Podcasts, Behavioral: Bite CounterParticipants in this group will receive podcasts twice weekly in conjunction with using a wearable wrist device called a Bite Counter. The Bite Counter tracks the number of bites/calories per bite. (Podcasts plus Bite Counter) |
| Podcast (+Mobile App) | Active comparator | Behavioral: Podcasts, Behavioral: Mobile Diet ApplicationParticipants in this group will receive podcasts twice weekly in conjunction with using a mobile application to track their diet. (Podcasts plus Mobile Diet Application) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must be between 18-65 years old
- Own and use a smartphone and/or a tablet with a data plan
- BMI must be between 25-49.9 kg/m2
- Must be willing to reduce caloric intake and increase physical activity
- Not currently participating in a weight loss study in a weight loss study that involved podcasts
Key exclusion criteria (5 listed)
- Over the age of 65 years old
- Currently participating in a weight loss program
- Has lost more than 10 pounds in the past 6 months
- Diagnosed with stroke or heart attack
- Diagnosed with diabetes that is controlled using medication
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 |
|---|---|---|
| PodcastsParticipants will receive twice weekly podcasts that will cover topics related to weight loss. | Behavioural | Podcast (+Bite Counter), Podcast (+Mobile App) |
| Mobile Diet ApplicationParticipants will use a mobile application on their smartphone to track their diet. | Behavioural | Podcast (+Mobile App) |
| Bite CounterParticipants will use a wrist-worn Bite Counter to track the number of bites in their diet per day. | Behavioural | Podcast (+Bite Counter) |
Primary outcome
Change in body weight as assessed by digital scale
Time frame: 6 months
Change in body weight from baseline to 6 months as assessed by digital scale.
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.
- Derived from this study: PubMed 31155473Turner-McGrievy GM, Dunn CG, Wilcox S, Boutte AK, Hutto B, Hoover A, Muth E. Defining Adherence to Mobile Dietary Self-Monitoring and Assessing Tracking Over Time: Tracking at Least Two Eating Occasions per Day Is Best Marker of Adherence within Two Different Mobile Health Randomized Weight Loss Interventions. J Acad Nutr Diet. 2019 Sep;119(9):1516-1524. doi: 10.1016/j.jand.2019.03.012. Epub 2019 May 30.
- Derived from this study: PubMed 28600833Turner-McGrievy GM, Wilcox S, Boutte A, Hutto BE, Singletary C, Muth ER, Hoover AW. The Dietary Intervention to Enhance Tracking with Mobile Devices (DIET Mobile) Study: A 6-Month Randomized Weight Loss Trial. Obesity (Silver Spring). 2017 Aug;25(8):1336-1342. doi: 10.1002/oby.21889. Epub 2017 Jun 10.
- Individual participant dataSharing planned: Undecided
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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 principal investigator
University of South Carolina School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Podcasts, Mobile Diet Application and Bite Counter 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 5 inclusion and 5 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?
Change in body weight as assessed by digital scale (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02632461, which also lists 2 linked publications.
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.