- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05343585
Validity of an AI-based Program to Identify Foods and Estimate Food Portion Size (PortionSizeAI)
Testing the Validity of an Artificial Intelligence-based Program to Identify Foods and Estimate Food Portion Size Among Adults, a Pilot Study
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70808
- Pennington Biomedical Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male or female
- Aged 18-62 years
- Self-reported body mass index (BMI) 18.5-50 kg/m2
Exclusion Criteria:
- Any condition or circumstance that could impede study completion
- Unfamiliar with or not able to use an iPhone
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identification of Food Plated Using the Openfit Mobile App
Time Frame: One study visit of ~2 hours
|
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
Time Frame: One study visit of ~2 hours
|
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
Time Frame: One study visit of ~2 hours
|
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
Time Frame: One study visit of ~2 hours
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identification of plate waste using the Openfit mobile app
Time Frame: One study visit of ~2 hours
|
Agreement surrounding identification of plate waste compared with known identification, at the item level, and across all items, where identification is determined by: 1) Nutrition AI without user 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 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 plate waste was correctly identified. |
One study visit of ~2 hours
|
Portion size estimation (gram weight) of plate waste using the Openfit mobile app
Time Frame: One study visit of ~2 hours
|
Error between mean estimates of portion weights (gram weight) and known portion weights (gram weight), where estimates of plate waste are 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 plate waste from the Nutrition AI compared to estimations from the criterion measure (weighed food). |
One study visit of ~2 hours
|
Portion size estimation (kcal) of plate waste using the Openfit mobile app
Time Frame: One study visit of ~2 hours
|
Error between mean estimates of portion size (kcal) and known portion size (kcal), where estimates of plate waste are 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 plate waste 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 plate waste
Time Frame: One study visit of ~2 hours
|
After completing assessment of plate waste, participants will complete a user satisfaction survey. The investigators adapted a 10-question user satisfaction survey that has been administered in prior studies to quantify satisfaction, ease of use, and adequacy of training for mobile apps. Responses to the user satisfaction questionnaire will be assessed using frequencies and percentages for Likert scale data. Open responses will be evaluated using qualitative methods to identify common themes. |
One study visit of ~2 hours
|
Portion size estimation (gram weight) of food intake using the Openfit mobile app
Time Frame: One study visit of ~2 hours
|
Error between mean estimates of portion weights (gram weight) and known portion weights (gram weight), where estimates of food intake (food plated - plate waste) are 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 intake from the Nutrition AI compared to estimations from the criterion measure (weighed food). |
One study visit of ~2 hours
|
Portion size estimation (kcal) of food intake using the Openfit mobile app
Time Frame: One study visit of ~2 hours
|
Error between mean estimates of food intake (kcal) and known food intake (kcal), where estimates of food intake (food plated - plate waste) are 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 intake from the Nutrition AI compared to estimations from the criterion measure (weighed food). |
One study visit of ~2 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Chloe P Lozano, PhD, Pennington Biomedical Research Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PBRC 2022-011
- T32DK064584 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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