Obesity2-SMARTNCT02868853
Self-Monitoring Assessment in Real Time
A study testing Photo App, Diet App and Podcasts 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 methods of mobile dietary self-monitoring for weight loss. 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?
- Photo App, Diet App and Podcasts
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to May 2017
- 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 that is apple of Android compatible
- 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 or has been in a weight loss study that involved podcasts or diet apps
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: Self-Monitoring Assessment in Real Time: 2-SMART
The purpose of the study is to test the effectiveness of two different methods of mobile dietary self-monitoring for weight loss. 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 an assigned mobile applications (for their smartphone), which will be randomly assigned.
Read the detailed description
This study will include an intensive phase for 6 weeks and a follow-up phase that will occur through the final 6 months of the study. Participants will attend one 1-hour orientation meeting at the beginning of the study and a 2-hour baseline assessment and training meeting. A final assessment will be conducted at the end of 6 weeks with a follow-up assessment at 6 months. 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 also will be randomized to track diet with one of the two mobile dietary tracking applications that will be used in the study. Participants will be encouraged to monitor their exercise and body weight.
- Conditions
- Obesity
- Being tested
- Photo App, Diet App, Podcasts
- Keywords
- diet, weight loss, tracking, mobile, 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.
Photo AppBehavioural
Use of a mobile photo app that takes pictures of foods consumed and allows users to share these pictures with other members of the study in order to receive feedback.
Diet AppBehavioural
Use of a mobile diet app that allows users to track all foods and beverages consumed in order to calculate the calories consumed each day.
PodcastsBehavioural
Listen to 2 podcasts per week about healthy eating and exercise.
| Study group | Role | What they receive |
|---|---|---|
| Photo App | Experimental | Participants in this group will receive podcasts twice weekly in conjunction with using a mobile dietary tracking application(Photo App). This Photo App allows participants to track meals by taking photos. Receives: Behavioral: Photo App; Behavioral: Podcasts |
| Diet App | Active comparator | Participants in this group will receive podcasts twice weekly in conjunction with an app (Diet App) to track their diet by entering in foods and beverages consumed. Receives: Behavioral: Diet App; Behavioral: Podcasts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days diet is self-monitored
Assess the total number of days food is recorded via assigned app over the 6-week study and then assess follow-up at 6 months.
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 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionMay 2017
- Study completionMay 2017
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.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Academy of Nutrition and Dietetics
- Responsible party
- Principal investigator, Brie Turner-McGrievy, University of South Carolina
- Investigators
- Brie McGrievy, PhD, MS, RD, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02868853
- Sponsor's protocol ID
- Pro00055836
- Acronym
- 2-SMART
- Status last verified
- Apr 2019
- First submitted
- 18 Jul 2016
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Dunn CG, Turner-McGrievy GM, Wilcox S, Hutto B. Dietary Self-Monitoring Through Calorie Tracking but Not Through a Digital Photography App Is Associated with Significant Weight Loss: The 2SMART Pilot Study-A 6-Month Randomized Trial. J Acad Nutr Diet. 2019 Sep;119(9):1525-1532. doi: 10.1016/j.jand.2019.03.013. Epub 2019 May 30.
PubMed 31155474Turner-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 31155473
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Monitoring Assessment in Real Time: 2-SMART
- ClinicalTrials.gov ID
- NCT02868853
- Acronym / sponsor ID
- 2-SMART / Pro00055836
- Conditions
- Obesity
- Keywords
- diet, weight loss, tracking, mobile, calories
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- Academy of Nutrition and Dietetics
- Study start
- Sep 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 16 Aug 2016 (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 methods of mobile dietary self-monitoring for weight loss. 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 an assigned mobile applications (for their smartphone), which will be randomly assigned.
Detailed description
This study will include an intensive phase for 6 weeks and a follow-up phase that will occur through the final 6 months of the study. Participants will attend one 1-hour orientation meeting at the beginning of the study and a 2-hour baseline assessment and training meeting. A final assessment will be conducted at the end of 6 weeks with a follow-up assessment at 6 months. 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 also will be randomized to track diet with one of the two mobile dietary tracking applications that will be used in the study. Participants will be encouraged to monitor their exercise and body weight.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photo App | Experimental | Behavioral: Photo App, Behavioral: PodcastsParticipants in this group will receive podcasts twice weekly in conjunction with using a mobile dietary tracking application(Photo App). This Photo App allows participants to track meals by taking photos. |
| Diet App | Active comparator | Behavioral: Diet App, Behavioral: PodcastsParticipants in this group will receive podcasts twice weekly in conjunction with an app (Diet App) to track their diet by entering in foods and beverages consumed. |
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 that is apple of Android compatible
- 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 or has been in a weight loss study that involved podcasts or diet apps
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 |
|---|---|---|
| Photo AppUse of a mobile photo app that takes pictures of foods consumed and allows users to share these pictures with other members of the study in order to receive feedback. | Behavioural | Photo App |
| Diet AppUse of a mobile diet app that allows users to track all foods and beverages consumed in order to calculate the calories consumed each day. | Behavioural | Diet App |
| PodcastsListen to 2 podcasts per week about healthy eating and exercise. | Behavioural | Diet App, Photo App |
Primary outcome
Number of days diet is self-monitored
Time frame: 6 months
Assess the total number of days food is recorded via assigned app over the 6-week study and then assess follow-up at 6 months.
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 17 Apr 2019.
- Derived from this study: PubMed 31155474Dunn CG, Turner-McGrievy GM, Wilcox S, Hutto B. Dietary Self-Monitoring Through Calorie Tracking but Not Through a Digital Photography App Is Associated with Significant Weight Loss: The 2SMART Pilot Study-A 6-Month Randomized Trial. J Acad Nutr Diet. 2019 Sep;119(9):1525-1532. doi: 10.1016/j.jand.2019.03.013. Epub 2019 May 30.
- 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.
- Individual participant dataSharing planned: Undecided
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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 McGrievy, PhD, MS, RD 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 Photo App, Diet App and Podcasts 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 17 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?
Number of days diet is self-monitored (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 NCT02868853, 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 17 Apr 2019.