NCT03578458

Brief 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. 1.During each eating occasion to report foods and amounts consumed
  2. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

May 31, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 6, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2018

Completed
Last Updated

April 24, 2019

Status Verified

April 1, 2019

Enrollment Period

6 months

First QC Date

May 24, 2018

Last Update Submit

April 23, 2019

Conditions

Dietary Assessment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Energy and nutrient content captured on the mobile application by taking photographs of food 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.

    Day 1 intakes will be reviewed by recall method

Study Arms (3)

US Healthy diet

OTHER

Subjects will install a mobile app for use and will be randomly assigned to a healthy diet.

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.

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.

Other: subjects will install a mobile app for use

Interventions

subjects will install a mobile app for useOTHER

novel mobile application

Mediterranean dietUS Healthy dietVegetarian diet

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Generally healthy men and women 18-65 years of age
  • Eats a wide variety of foods from all food groups
  • ≤ 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tufts University USDA Human Nutrition Research Center on Aging (HNRCA)

Boston, Massachusetts, 02111, United States

Location

Related Publications (1)

  • 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.

    PMID: 33693732DERIVED

Study Officials

  • Sai Krupa Das, Ph.D

    Tufts University USDA Human Nutrition Research Center on Aging (HNRCA), Boston MA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2018

First Posted

July 6, 2018

Study Start

May 31, 2018

Primary Completion

November 27, 2018

Study Completion

November 27, 2018

Last Updated

April 24, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)