Dietary AssessmentNCT03578458
Novel Mobile Application to Assess Dietary Information
A study testing subjects will install a mobile app for use in people with Dietary Assessment, run by Société des Produits Nestlé (SPN) at 1 site in United States.
Trial summary
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: 1. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Assessment
- What is being tested?
- subjects will install a mobile app for use
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2018to 27 Nov 2018
- 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
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts University USDA Human Nutrition Research Center on Aging (HNRCA)
Boston, Massachusetts, 02111
About this study
Official title: 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.
- Conditions
- Dietary Assessment
- Being tested
- subjects will install a mobile app for use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subjects will install a mobile app for useOther
novel mobile application
| Study group | Role | What they receive |
|---|---|---|
| US Healthy diet | Other | Subjects will install a mobile app for use and will be randomly assigned to a healthy diet. Receives: Other: subjects will install a mobile app for use |
| Vegetarian diet | Other | Subjects will install a mobile app for use and will be randomly assigned to a vegetarian diet. Receives: Other: subjects will install a mobile app for use |
| Mediterranean diet | Other | Subjects will install a mobile app for use and will be randomly assigned to a Mediterranean diet. Receives: Other: subjects will install a mobile app for use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy and nutrient content captured on the mobile application
During each eating occasion to report foods and amounts consumed
Measured: Day 1 intakes recorded on application after meals
Secondary outcomes (2)
Energy and nutrient content captured on the mobile application by taking photographs of food consumed
During each eating occasion to report foods and amounts consumed
Measured: Day 1 intakes photographed on application after meals
Assess whether food capture using the mobile application is comparable with a conventional 24-hour recall.
Use of application for food capture versus 24 hour dietary recall in reporting foods and amounts consumed
Measured: Day 1 intakes will be reviewed by recall method
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start31 May 2018
- Primary completion27 Nov 2018
- Study completion27 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dietary AssessmentStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sai Krupa Das, Ph.D, Principal investigator, Tufts University USDA Human Nutrition Research Center on Aging (HNRCA), Boston MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578458
- Sponsor's protocol ID
- 17.13.NIHS
- Status last verified
- Apr 2019
- First submitted
- 24 May 2018
- Last updated
- 24 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blanchard CM, Chin MK, Gilhooly CH, Barger K, Matuszek G, Miki AJ, Cote RG, Eldridge AL, Green H, Mainardi F, Mehers D, Ronga F, Steullet V, Das SK. Evaluation of PIQNIQ, a Novel Mobile Application for Capturing Dietary Intake. J Nutr. 2021 May 11;151(5):1347-1356. doi: 10.1093/jn/nxab012.
PubMed 33693732
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Mobile Application to Assess Dietary Information
- ClinicalTrials.gov ID
- NCT03578458
- Acronym / sponsor ID
- 17.13.NIHS
- Conditions
- Dietary Assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 31 May 2018 (actual)
- Primary completion
- 27 Nov 2018 (actual)
- Study completion
- 27 Nov 2018 (actual)
- First posted
- 6 Jul 2018 (actual)
- 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 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| US Healthy diet | Other | Other: subjects will install a mobile app for useSubjects will install a mobile app for use and will be randomly assigned to a healthy diet. |
| Vegetarian diet | Other | Other: subjects will install a mobile app for useSubjects will install a mobile app for use and will be randomly assigned to a vegetarian diet. |
| Mediterranean diet | Other | Other: subjects will install a mobile app for useSubjects will install a mobile app for use and will be randomly assigned to a Mediterranean diet. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| subjects will install a mobile app for usenovel mobile application | Other | Mediterranean diet, US Healthy diet, Vegetarian diet |
Primary outcome
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
2 secondary outcomes
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
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
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 24 Apr 2019.
- Derived from this study: PubMed 33693732Blanchard CM, Chin MK, Gilhooly CH, Barger K, Matuszek G, Miki AJ, Cote RG, Eldridge AL, Green H, Mainardi F, Mehers D, Ronga F, Steullet V, Das SK. Evaluation of PIQNIQ, a Novel Mobile Application for Capturing Dietary Intake. J Nutr. 2021 May 11;151(5):1347-1356. doi: 10.1093/jn/nxab012.
- Individual participant dataSharing planned: No
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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.
Sai Krupa Das, Ph.D principal investigator
Tufts University USDA Human Nutrition Research Center on Aging (HNRCA), Boston MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing subjects will install a mobile app for use in people with Dietary Assessment, run by Société des Produits Nestlé (SPN) 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 12 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 24 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?
Energy and nutrient content captured on the mobile application (time frame: Day 1 intakes recorded on application after meals). 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 NCT03578458, which also lists 1 linked publication.
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 24 Apr 2019.