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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03578458
Other study ID # 17.13.NIHS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 31, 2018
Est. completion date November 27, 2018

Study information

Verified date April 2019
Source Nestlé
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. During each eating occasion to report foods and amounts consumed

2. 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.


Recruitment information / eligibility

Status Completed
Enrollment 132
Est. completion date November 27, 2018
Est. primary completion date November 27, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
subjects will install a mobile app for use
novel mobile application

Locations

Country Name City State
United States Tufts University USDA Human Nutrition Research Center on Aging (HNRCA) Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Nestlé

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Energy and nutrient content captured on the mobile application During each eating occasion to report foods and amounts consumed Day 1 intakes recorded on application after meals
Secondary 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 Day 1 intakes photographed on application after meals
Secondary 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 Day 1 intakes will be reviewed by recall method
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