Diet HabitNCT03267004
Dietary Assessment Study Via Digital Images
A study testing Dietary Assessment of Meal A using images taken by Sony Smarteyeglass and Dietary Assessment of Meal B using Images taken by Sony Smarteyeglass in people with Diet Habit, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial summary
The purpose of this investigation is to validate a passive image-assisted dietary assessment method using images taken by Sony Smarteyeglass and an automatic image analysis software, DietCam, to identify food items and estimate portion sizes. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet Habit
- What is being tested?
- Dietary Assessment of Meal A using images taken by Sony Smarteyeglass and Dietary Assessment of Meal B using Images taken by Sony Smarteyeglass
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2017to 3 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- between the ages of 18 and 65 years;
- body mass index (BMI) 18.5 to 24.9 kg/m2;
- no food allergies/intolerance to foods used in the investigation;
- report not having a dietary plan or dietary restrictions that prevents consumption of the foods used in the investigation;
- report a favorable preference for the foods served in the meal, with participants rate each food item 3 on a Likert scale during the phone screen;
- able to complete all two meal sessions within four weeks of the screening session;
- are not legally blind without corrected lenses; and
- are able to eat a meal while wearing the Sony Smarteyeglass.
Who cannot join
- wear electronic medical devices such as pacemakers and implantable defibrillators
Trial locations and contacts
1 site in 1 country.
United States1 site
Healthy Eating and Activity Laboratory, University of Tennessee
Knoxville, Tennessee, 37996
About this study
Official title: Validation Study of a Passive Image-Assisted Dietary Assessment With Automated Image Analysis Process
The purpose of this investigation is to validate a passive image-assisted dietary assessment method using images taken by Sony Smarteyeglass and an automatic image analysis software, DietCam, to identify food items and estimate portion sizes. Participants will be randomized into one of the two orders of meals (Order 1 and 2). In each meal, participants will be given a meal that includes a regular-shaped single food (i.e., cookie), an irregular-shape single food (i.e., ice cream), a regular-shaped mixed food (i.e., sandwich), and irregular-shaped mixed food (i.e., pasta dish).
Read the detailed description
All participants will be asked to come to Healthy Eating and Activity Laboratory for 1, 30-minute screening session, and then for 2, 40-minute meal sessions, with approximately one week occurring between each session. Sessions will be scheduled between 11:00am and 5:00pm, Monday to Friday. During the screening session, interested participants will sign the consent form. After signing the consent from, eligibility will be confirmed by taking height and weight measures. Participants will also be given questionnaires related to demographics. Prior to the start of the first meal session, eligible participants will be randomized to one of the two orders (Order 1 and 2), using a random numbers table. Participants will be instructed for the meal sessions to stop eating a minimum of two hours prior to the scheduled meal sessions and only consume water during that period.
During both meal sessions, instructions on how to use Sony Smarteyeglass will be provided to participants. These instructions will include how to wear and use the eyeglasses. Participants will be instructed that, after putting on the Smarteyeglass, to initiate the recording via the controller of the Sony Smarteyeglass. After the recording is initiated and prior to starting to eat, participants will be instructed to look at each provided food at the table. Then, participants will also be instructed to turn their head toward the left shoulder, look at each food from the side, and then repeat the same step for turning their head toward the right shoulder. Participants will be asked to start the meal by taking one bite of each provided food. For the first bite of each food, participants will be instructed to hold the food, either in their hand or on a fork or spoon (depending on the food), approximately 12 inches in front of the eyeglasses and to look at the food. Following taking the first bite of each provided food, participants will be instructed to eat normally until satisfied. Participants will be given 30 minutes to eat. The investigator will leave the room while the participant is eating. The investigator will check in with participants every 10 minutes. At the end of 30 minutes, participants will be instructed to again look at each provided food on the table at three different angles (looking straight at each food, from left side and the right side) following the exact same procedure at the beginning of the meal.
On the day following each meal session, participants will be called to complete a 24-hour dietary recall, which will take 20 minutes to complete. Instructions will be provided to participants at the end of each meal session about how to complete the dietary recall and a two-dimensional visual aid will be provided to aid participants in estimating the consumed portions for each food and beverage item consumed.
The second meal session will follow the same procedure as the first session. At the end of second meal session, participants will be asked to complete a questionnaire to provide feedback on their use of the Sony Smarteyeglass.
For the first and second meal session, the meals will contain foods that are categorized into two food shapes (Regular and Irregular) and two food complexities (Single food and Mixed food). Each meal will contain four foods with the four foods representing the four potential food categories (regular-shaped single food, irregular-shaped single food, regular-shaped mixed food, irregular-shaped mixed food). Along with the four foods, participants will be given 20oz of water in each meal session. Foods will be weighed prior to being provided to participants and the amount provided to participants will be within +/- 3g of the amount calculated. Mixed foods will be broken down into their individual food components and measured. Each meal will provide approximately 50% of daily estimated energy need for each sex. The Estimated Calories Needed Per Day for males and females aged 19 to 35 years are 2450 kcal/day and 1900 kcal/day, respectively. Thus, each meal will provide approximately 1225 kcal for males and 950 kcal for females. Each food will provide approximately 25% of the energy for each meal.
- Conditions
- Diet Habit
- Being tested
- Dietary Assessment of Meal A using images taken by Sony Smarteyeglass, Dietary Assessment of Meal B using Images taken by Sony Smarteyeglass
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Assessment of Meal A using images taken by Sony SmarteyeglassDevice
Participant will be wearing Sony Smarteyeglass to record digital images while eating meal A in the laboratory
Meal A:
Turkey and Provolone Cheese Sandwich [whole wheat bread 52g(female \& male), Turkey 70g(female) \& 133g(male), Provolone cheese 23g(female \& male), tomato 50g(female \& male), lettuce 45g(female \& male)]; Chicken and wild rice [chicken 98g(female \& male), wild rice 71g(female) \& 107g(male)]; chocolate chips cookies [44g(female) \& 60.5g(male)]; potato chips [39g(female) \& 52g(male)].
Dietary Assessment of Meal B using Images taken by Sony SmarteyeglassDevice
Participant will be wearing Sony Smarteyeglass to record digital images while eating meal B in the laboratory
Meal B:
Ham \& Cheddar cheese wrap [Tortilla 45g(female \& male), Ham deli 76g(female) \& 103g(male), cheddar cheese 21g(female) \& 32g(male), Spring Mix 36g(female \& male), Fat Free ranch dressing 29g(female \& male)]; Pasta with broccoli and Alfredo sauce [Pasta 91g(female) \& 121g(male), Broccoli 66g(female \& male), Alfredo sauce 38g(female) \& 50g(male)]; Chocolate Ice-cream [107g(female), 138g(male)]; Red seedless grapes [365g (female), 471g(male)].
| Study group | Role | What they receive |
|---|---|---|
| Meal Order 1 | Experimental | Meal A will be served to participant in meal session 1 and Meal B in meal session 2. Receives: Device: Dietary Assessment of Meal A using images taken by Sony Smarteyeglass; Device: Dietary Assessment of Meal B using Images taken by Sony Smarteyeglass |
| Meal Order 2 | Experimental | Meal B will be served to participant in meal session 1 and Meal A in meal session 2. Receives: Device: Dietary Assessment of Meal A using images taken by Sony Smarteyeglass; Device: Dietary Assessment of Meal B using Images taken by Sony Smarteyeglass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weighed Food Intake
Before and after each meal session, each food items will be weighed to the nearest tenth of a gram using an electronic food scale. Assessing the weight change of food intake.
Measured: Meal session 1 and 2 within 4 weeks of initial screening session
24-hour Dietary Recall
On the following day of each meal session, the investigator will ask the participant to recall their dietary intake by having the participant reporting all foods and beverages consumed and the time in which they consumed these items within the past 24 hours. Participants will be asked what time of day the foods and beverages were consumed and will be shown two-dimensional food shapes to help with estimating portion sizes. Only dietary intake for the meal session will be entered into NDS-R to convert to commonly used measurements.
Measured: The following day of meal session 1 and 2 within 4 weeks of initial screening session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start3 Aug 2017
- Primary completion3 Aug 2018
- Study completion3 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diet HabitStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- A 2x2x2x2x3 mixed factorial design will be used, with a between-subject factor of the order of meals (Order 1 and 2) and within-subject factors of food shapes (Regular and Irregular), food complexities (Single food and Mixed food), meals (Meal A and B), and methods of measurement (DietCam, weighed food intake, and 24-hour dietary recall).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hollie Raynor, The University of Tennessee, Knoxville
- Investigators
- Tsz-Kiu Chui, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267004
- Sponsor's protocol ID
- UTK IRB-17-03829-XP
- Status last verified
- Apr 2025
- First submitted
- 10 Aug 2017
- Last updated
- 8 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
U.S. Department of Health and Human Services; U.S. Department of Agriculture. 2015-2020 Dietary guidelines for Americans. Appendix 2. Estimated Calorie Needs per Day, by Age, Sex, and Physical Activity Level 2015; 8th Edition:http://health.gov.dietaryguidelines/2015/guidelines/. Accessed April 18, 2017.
Lohman TR, Roche AF, Martorell R. Anthropometric Standardization Reference Manual. Champaign,Illinois: Human Kinetics Books; 1988.
He H, Kong F, Tan J. DietCam: Multiview Food Recognition Using a Multikernel SVM. IEEE J Biomed Health Inform. 2016 May;20(3):848-855. doi: 10.1109/JBHI.2015.2419251. Epub 2015 Apr 2.
PubMed 25850095Sony Coporation. Smarteyeglass: API Overview. 2017; https://developer.sony.com/develop/wearables/smarteyeglass-sdk/api-overview/. Accessed Feb, 2017.
Chui TK, Tan J, Li Y, Raynor HA. Validating an automated image identification process of a passive image-assisted dietary assessment method: proof of concept. Public Health Nutr. 2020 Oct;23(15):2700-2710. doi: 10.1017/S1368980020000816. Epub 2020 Jun 10.
PubMed 32517834
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Study of a Passive Image-Assisted Dietary Assessment With Automated Image Analysis Process
- ClinicalTrials.gov ID
- NCT03267004
- Acronym / sponsor ID
- UTK IRB-17-03829-XP
- Conditions
- Diet Habit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Study start
- 3 Aug 2017 (actual)
- Primary completion
- 3 Aug 2018 (actual)
- Study completion
- 3 Jun 2020 (actual)
- First posted
- 30 Aug 2017 (actual)
- Results
- Posted 9 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this investigation is to validate a passive image-assisted dietary assessment method using images taken by Sony Smarteyeglass and an automatic image analysis software, DietCam, to identify food items and estimate portion sizes. Participants will be randomized into one of the two orders of meals (Order 1 and 2). In each meal, participants will be given a meal that includes a regular-shaped single food (i.e., cookie), an irregular-shape single food (i.e., ice cream), a regular-shaped mixed food (i.e., sandwich), and irregular-shaped mixed food (i.e., pasta dish).
Detailed description
All participants will be asked to come to Healthy Eating and Activity Laboratory for 1, 30-minute screening session, and then for 2, 40-minute meal sessions, with approximately one week occurring between each session. Sessions will be scheduled between 11:00am and 5:00pm, Monday to Friday. During the screening session, interested participants will sign the consent form. After signing the consent from, eligibility will be confirmed by taking height and weight measures. Participants will also be given questionnaires related to demographics. Prior to the start of the first meal session, eligible participants will be randomized to one of the two orders (Order 1 and 2), using a random numbers table. Participants will be instructed for the meal sessions to stop eating a minimum of two hours prior to the scheduled meal sessions and only consume water during that period.
During both meal sessions, instructions on how to use Sony Smarteyeglass will be provided to participants. These instructions will include how to wear and use the eyeglasses. Participants will be instructed that, after putting on the Smarteyeglass, to initiate the recording via the controller of the Sony Smarteyeglass. After the recording is initiated and prior to starting to eat, participants will be instructed to look at each provided food at the table. Then, participants will also be instructed to turn their head toward the left shoulder, look at each food from the side, and then repeat the same step for turning their head toward the right shoulder. Participants will be asked to start the meal by taking one bite of each provided food. For the first bite of each food, participants will be instructed to hold the food, either in their hand or on a fork or spoon (depending on the food), approximately 12 inches in front of the eyeglasses and to look at the food. Following taking the first bite of each provided food, participants will be instructed to eat normally until satisfied. Participants will be given 30 minutes to eat. The investigator will leave the room while the participant is eating. The investigator will check in with participants every 10 minutes. At the end of 30 minutes, participants will be instructed to again look at each provided food on the table at three different angles (looking straight at each food, from left side and the right side) following the exact same procedure at the beginning of the meal.
On the day following each meal session, participants will be called to complete a 24-hour dietary recall, which will take 20 minutes to complete. Instructions will be provided to participants at the end of each meal session about how to complete the dietary recall and a two-dimensional visual aid will be provided to aid participants in estimating the consumed portions for each food and beverage item consumed.
The second meal session will follow the same procedure as the first session. At the end of second meal session, participants will be asked to complete a questionnaire to provide feedback on their use of the Sony Smarteyeglass.
For the first and second meal session, the meals will contain foods that are categorized into two food shapes (Regular and Irregular) and two food complexities (Single food and Mixed food). Each meal will contain four foods with the four foods representing the four potential food categories (regular-shaped single food, irregular-shaped single food, regular-shaped mixed food, irregular-shaped mixed food). Along with the four foods, participants will be given 20oz of water in each meal session. Foods will be weighed prior to being provided to participants and the amount provided to participants will be within +/- 3g of the amount calculated. Mixed foods will be broken down into their individual food components and measured. Each meal will provide approximately 50% of daily estimated energy need for each sex. The Estimated Calories Needed Per Day for males and females aged 19 to 35 years are 2450 kcal/day and 1900 kcal/day, respectively. Thus, each meal will provide approximately 1225 kcal for males and 950 kcal for females. Each food will provide approximately 25% of the energy for each meal.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- A 2x2x2x2x3 mixed factorial design will be used, with a between-subject factor of the order of meals (Order 1 and 2) and within-subject factors of food shapes (Regular and Irregular), food complexities (Single food and Mixed food), meals (Meal A and B), and methods of measurement (DietCam, weighed food intake, and 24-hour dietary recall).
| Arm | Type | Receives |
|---|---|---|
| Meal Order 1 | Experimental | Device: Dietary Assessment of Meal A using images taken by Sony Smarteyeglass, Device: Dietary Assessment of Meal B using Images taken by Sony SmarteyeglassMeal A will be served to participant in meal session 1 and Meal B in meal session 2. |
| Meal Order 2 | Experimental | Device: Dietary Assessment of Meal A using images taken by Sony Smarteyeglass, Device: Dietary Assessment of Meal B using Images taken by Sony SmarteyeglassMeal B will be served to participant in meal session 1 and Meal A in meal session 2. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- between the ages of 18 and 65 years;
- body mass index (BMI) 18.5 to 24.9 kg/m2;
- no food allergies/intolerance to foods used in the investigation;
- report not having a dietary plan or dietary restrictions that prevents consumption of the foods used in the investigation;
- report a favorable preference for the foods served in the meal, with participants rate each food item 3 on a Likert scale during the phone screen;
Key exclusion criteria (1 listed)
- wear electronic medical devices such as pacemakers and implantable defibrillators
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 |
|---|---|---|
| Dietary Assessment of Meal A using images taken by Sony SmarteyeglassParticipant will be wearing Sony Smarteyeglass to record digital images while eating meal A in the laboratory Meal A: Turkey and Provolone Cheese Sandwich [whole wheat bread 52g(female \& male), Turkey 70g(female) \& 133g(male), Provolone cheese 23g(female \& male), tomato 50g(female \& male), lettuce 45g(female \& male)]; Chicken and wild rice [chicken 98g(female \& male), wild rice 71g(female) \& 107g(male)]; chocolate chips cookies [44g(female) \& 60.5g(male)]; potato chips [39g(female) \& 52g(male)]. | Device | Meal Order 1, Meal Order 2 |
| Dietary Assessment of Meal B using Images taken by Sony SmarteyeglassParticipant will be wearing Sony Smarteyeglass to record digital images while eating meal B in the laboratory Meal B: Ham \& Cheddar cheese wrap [Tortilla 45g(female \& male), Ham deli 76g(female) \& 103g(male), cheddar cheese 21g(female) \& 32g(male), Spring Mix 36g(female \& male), Fat Free ranch dressing 29g(female \& male)]; Pasta with broccoli and Alfredo sauce [Pasta 91g(female) \& 121g(male), Broccoli 66g(female \& male), Alfredo sauce 38g(female) \& 50g(male)]; Chocolate Ice-cream [107g(female), 138g(male)]; Red seedless grapes [365g (female), 471g(male)]. | Device | Meal Order 1, Meal Order 2 |
Primary outcome
Weighed Food Intake
Time frame: Meal session 1 and 2 within 4 weeks of initial screening session
Before and after each meal session, each food items will be weighed to the nearest tenth of a gram using an electronic food scale. Assessing the weight change of food intake.
24-hour Dietary Recall
Time frame: The following day of meal session 1 and 2 within 4 weeks of initial screening session
On the following day of each meal session, the investigator will ask the participant to recall their dietary intake by having the participant reporting all foods and beverages consumed and the time in which they consumed these items within the past 24 hours. Participants will be asked what time of day the foods and beverages were consumed and will be shown two-dimensional food shapes to help with estimating portion sizes. Only dietary intake for the meal session will be entered into NDS-R to convert to commonly used measurements.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundU.S. Department of Health and Human Services; U.S. Department of Agriculture. 2015-2020 Dietary guidelines for Americans. Appendix 2. Estimated Calorie Needs per Day, by Age, Sex, and Physical Activity Level 2015; 8th Edition:http://health.gov.dietaryguidelines/2015/guidelines/. Accessed April 18, 2017.
- BackgroundLohman TR, Roche AF, Martorell R. Anthropometric Standardization Reference Manual. Champaign,Illinois: Human Kinetics Books; 1988.
- Background: PubMed 25850095He H, Kong F, Tan J. DietCam: Multiview Food Recognition Using a Multikernel SVM. IEEE J Biomed Health Inform. 2016 May;20(3):848-855. doi: 10.1109/JBHI.2015.2419251. Epub 2015 Apr 2.
- BackgroundSony Coporation. Smarteyeglass: API Overview. 2017; https://developer.sony.com/develop/wearables/smarteyeglass-sdk/api-overview/. Accessed Feb, 2017.
- Derived from this study: PubMed 32517834Chui TK, Tan J, Li Y, Raynor HA. Validating an automated image identification process of a passive image-assisted dietary assessment method: proof of concept. Public Health Nutr. 2020 Oct;23(15):2700-2710. doi: 10.1017/S1368980020000816. Epub 2020 Jun 10.
- 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.
Tsz-Kiu Chui principal investigator
University of Tennessee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Assessment of Meal A using images taken by Sony Smarteyeglass and Dietary Assessment of Meal B using Images taken by Sony Smarteyeglass in people with Diet Habit, run by The University of Tennessee, Knoxville 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 8 inclusion and 1 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 8 Apr 2025. 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?
Yes. Results are posted in the registry (first posted 9 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Weighed Food Intake (time frame: Meal session 1 and 2 within 4 weeks of initial screening session). The study lists 2 primary outcomes in all. 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 NCT03267004, which also lists 5 linked publications.
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 8 Apr 2025.