- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03578458
Novel Mobile Application to Assess Dietary Information
April 23, 2019 updated by: Nestlé
Evaluation of a Novel Mobile Application to Assess Dietary Information
The study will assess the accuracy of food capture methods using a novel mobile application. This will be done by comparing the energy and nutrient content of reported foods against those of foods actually consumed (i.e., reported vs actual). Two methods of using the application will be tested:
- During each eating occasion to report foods and amounts consumed
- By taking photographs of every food consumed, using the camera functionality of the mobile application and using the application the following day (according to the availability of the study subjects) to report foods and amounts consumed. This is to be consistent with the concept of a 24-hour dietary recall.
One group will use a standard 24-hour dietary recall method.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
132
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
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02111
- Tufts University USDA Human Nutrition Research Center on Aging (HNRCA)
-
-
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:
- Generally healthy men and women 18-65 years of age
- Eats a wide variety of foods from all food groups
- 18 ≤ body mass index (BMI) < 30 kg/m2
- Ability to read and write in English
- iPhone (iOS 11 or higher) or Android phone (6 or higher) user willing to download the mobile application
Exclusion Criteria:
- Presence of active disease at screening that would prevent normal dietary intake and/or would result in weight loss (irritable bowel syndrome, Crohn's disease, celiac disease, etc.)
- Medical complications or chronic illness that would prevent full participation (e.g., active cancer)
- Pregnant or lactating women
- Diagnosed eating disorder
- Vegetarian
- Special dietary requirements or severe allergies that prevent the consumption of major food groups (e.g., gluten free, lactose free, Halal)
- Diagnosis of a mental health condition that has not been stable within the past 6 months
- Current or previous experience with dietary data collection or analysis
- Concurrent participation in another research study at any point during the study
- Availability and access to a tablet device (iPad, Android) only
- Shift workers
- Plan to partake in vigorous physical training/ exercise during the study period (e.g., training for or running a marathon)
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
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: US Healthy diet
Subjects will install a mobile app for use and will be randomly assigned to a healthy diet.
|
novel mobile application
|
OTHER: Vegetarian diet
Subjects will install a mobile app for use and will be randomly assigned to a vegetarian diet.
|
novel mobile application
|
OTHER: Mediterranean diet
Subjects will install a mobile app for use and will be randomly assigned to a Mediterranean diet.
|
novel mobile application
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Energy and nutrient content captured on the mobile application
Time Frame: Day 1 intakes recorded on application after meals
|
During each eating occasion to report foods and amounts consumed
|
Day 1 intakes recorded on application after meals
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Energy and nutrient content captured on the mobile application by taking photographs of food consumed
Time Frame: Day 1 intakes photographed on application after meals
|
During each eating occasion to report foods and amounts consumed
|
Day 1 intakes photographed on application after meals
|
Assess whether food capture using the mobile application is comparable with a conventional 24-hour recall.
Time Frame: Day 1 intakes will be reviewed by recall method
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Use of application for food capture versus 24 hour dietary recall in reporting foods and amounts consumed
|
Day 1 intakes will be reviewed by recall method
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sai Krupa Das, Ph.D, Tufts University USDA Human Nutrition Research Center on Aging (HNRCA), Boston MA
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.
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 (ACTUAL)
May 31, 2018
Primary Completion (ACTUAL)
November 27, 2018
Study Completion (ACTUAL)
November 27, 2018
Study Registration Dates
First Submitted
May 24, 2018
First Submitted That Met QC Criteria
July 3, 2018
First Posted (ACTUAL)
July 6, 2018
Study Record Updates
Last Update Posted (ACTUAL)
April 24, 2019
Last Update Submitted That Met QC Criteria
April 23, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 17.13.NIHS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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