NCT05343585

Brief Summary

The purpose of this study is to test the accuracy of the Nutrition Artificial Intelligence in the Openfit app during meals in a controlled laboratory setting

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

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

April 12, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

April 27, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2022

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

November 18, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

1 month

First QC Date

April 12, 2022

Results QC Date

August 24, 2023

Last Update Submit

November 14, 2023

Conditions

Keywords

Nutrition Assessment

Outcome Measures

Primary Outcomes (4)

  • Identification of Food Plated Using the Openfit Mobile App

    Agreement surrounding identification of food and beverages provided compared with known identification, at the item level, and across all items where identification is determined by: 1) Nutrition AI without correction (automated), 2) Nutrition AI with user correction (semi-automated) For a food identified through the Nutrition AI to be considered an exact food match, the name of the food identified must match or be a close match to the food served. For example, a fruit cocktail identified as a fruit salad is an acceptable match. Proportions will be used to assess whether the percentage of food items plated that were correctly identified by Nutrition AI is different to the percentage of foods correctly identified by a criterion method (human rater). Descriptive data will also be used to describe the frequency at which food plated was correctly identified for all food items across all participants. In total there was 255 food items tested across all participants.

    One study visit of ~2 hours

  • Portion Size Estimation (kcal) of Food Plated Using the Openfit Mobile App

    Error between mean estimates of food plated (kcal) and known food plated (kcal), determined by: 1) Nutrition AI without user correction (automated), 2) Nutrition AI with user correction (semi-automated) Mean error and Bland-Altman analysis will be performed to determine errors in estimation of food plated from the Nutrition AI compared to estimations from the criterion measure (weighed food).

    One study visit of ~2 hours

  • User Satisfaction of the Openfit Mobile App for Recording Food Plated

    After completing assessment of food plated, participants will complete a user satisfaction survey (USS). The USS was adapted from a previous version used to assess the usability of a mobile application for dietary assessment. The USS includes five quantitative questions and three open response questions. The quantitative questions will each be scored using a 6-point Likert scale, with 1 being the lowest and worst score, and 6 being the highest and best score. Data for each of the five quantitative responses in the USS will be averaged across participants and presented separately as mean (SD). Open responses will be evaluated using qualitative methods to identify common themes.

    One study visit of ~2 hours

  • Usability of the Openfit Mobile App for Recording Food Plated

    Participants will complete the Computer Usability Satisfaction Questionnaire (CSUQ). The CSUQ is frequently used to assess the usability of mobile applications. The CSUQ consists of 19 questions, each scored using a 7-point Likert scale (with 1 being the lowest and best score and 7 being the highest and worst score) and participants will rate satisfaction, usefulness, information quality, and interface quality of the Openfit app. The average of these 19 questions (1 being the best average score and 7 being the worst average score) provides an overall usability score.

    One study visit of ~2 hours

Study Arms (1)

Experimental

EXPERIMENTAL

* Training and use of Openfit * Using the app to estimate food intake from simulated meals in a laboratory at PBRC or LSU (participants will not eat food during the meals) * Rating the usability and satisfaction of the app

Device: PortionSize AI

Interventions

For this pilot study, using a convenience sample, the investigators will recruit up to 25 adults to use the Nutrition AI technology in Openfit to identify and estimate portion size of foods provided in a laboratory setting at Pennington Biomedical Research Center (PBRC) and/or Louisiana State University (LSU). Laboratory members within the Ingestive Behavioral Laboratory will also test the ability of Nutrition AI to identify foods and to quantify foods provided in the laboratory. Meals will be simulated, and participants will not consume the foods provided.

Experimental

Eligibility Criteria

Age18 Years - 62 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female
  • Aged 18-62 years
  • Self-reported body mass index (BMI) 18.5-50 kg/m2

You may not qualify if:

  • Any condition or circumstance that could impede study completion
  • Unfamiliar with or not able to use an iPhone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (1)

  • Lozano CP, Canty EN, Saha S, Broyles ST, Beyl RA, Apolzan JW, Martin CK. Validity of an Artificial Intelligence-Based Application to Identify Foods and Estimate Energy Intake Among Adults: A Pilot Study. Curr Dev Nutr. 2023 Sep 29;7(11):102009. doi: 10.1016/j.cdnut.2023.102009. eCollection 2023 Nov.

Results Point of Contact

Title
Chloe Panizza Lozano
Organization
Pennington Biomedical Research Center

Study Officials

  • Chloe P Lozano, PhD

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 12, 2022

First Posted

April 25, 2022

Study Start

April 27, 2022

Primary Completion

June 3, 2022

Study Completion

June 3, 2022

Last Updated

November 18, 2023

Results First Posted

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Any identifiers might be removed from the participants identifiable information and after such removal, the information could be used for future research studies or given to another investigator for future research without additional informed consent from the subject or legally authorized representative.

Locations