- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02632461
Dietary Intervention Examining Tracking With Mobile Devices (DIETMobile)
April 16, 2019 updated by: Brie Turner-McGrievy, University of South Carolina
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
81
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
South Carolina
-
Columbia, South Carolina, United States, 29208
- University of South Carolina
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Podcast (+Bite Counter)
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)
|
Participants will receive twice weekly podcasts that will cover topics related to weight loss.
Participants will use a wrist-worn Bite Counter to track the number of bites in their diet per day.
|
|
Active Comparator: Podcast (+Mobile App)
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)
|
Participants will receive twice weekly podcasts that will cover topics related to weight loss.
Participants will use a mobile application on their smartphone to track their diet.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Brie Turner-McGrievy, University of South Carolina School of Public Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Turner-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. Erratum In: Obesity (Silver Spring). 2017 Dec;25(12 ):2156-2157.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2015
Primary Completion (Actual)
August 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
December 14, 2015
First Submitted That Met QC Criteria
December 15, 2015
First Posted (Estimate)
December 16, 2015
Study Record Updates
Last Update Posted (Actual)
April 18, 2019
Last Update Submitted That Met QC Criteria
April 16, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Pro00049756
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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