ClinicalTrials.gg
CompletedNCT03267004Updated Apr 8, 2025Results posted

Dietary Assessment Study Via Digital Images

An interventional study of Dietary Assessment of Meal A using images taken by Sony Smarteyeglass and Dietary Assessment of Meal B using Images taken by Sony Smarteyeglass in Diet Habit, sponsored by The University of Tennessee, Knoxville. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-08.

Sponsored by The University of Tennessee, Knoxville · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Diet Habit

Browse trials for

03

In context

Feeding Behavior

985 studies on the registry are indexed under Feeding Behavior; 178 are open to participants now.

This study's enrollment of 30 is below the median of 77 across 700 interventional studies indexed under Feeding Behavior.

Browse Feeding Behavior studies →

Lead sponsor

The University of Tennessee, Knoxville is the lead sponsor of 95 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • between the ages of 18 and 65 years;
  • (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.

Exclusion criteria

Exclusion Criteria:

  • wear electronic medical devices such as pacemakers and implantable defibrillators
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Investigator)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Meal Order 1

    Meal A will be served to participant in meal session 1 and Meal B in meal session 2.

    Device: Dietary Assessment of Meal A using images taken by Sony Smarteyeglass · Device: Dietary Assessment of Meal B using Images taken by Sony Smarteyeglass

  • Experimental
    Meal Order 2

    Meal B will be served to participant in meal session 1 and Meal A in meal session 2.

    Device: Dietary Assessment of Meal A using images taken by Sony Smarteyeglass · Device: Dietary Assessment of Meal B using Images taken by Sony Smarteyeglass

Interventions

  • DeviceDietary Assessment of Meal A using images taken by Sony Smarteyeglass

    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 \[39g(female) \& 52g(male)\].

  • DeviceDietary Assessment of Meal B using Images taken by Sony Smarteyeglass

    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 \[365g (female), 471g(male)\].

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Meal session 1 and 2 within 4 weeks of initial screening session

  2. 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.

    Time frame: The following day of meal session 1 and 2 within 4 weeks of initial screening session

07

Results

Posted Dec 9, 2024

Participant flow

Participant flow — Overall Study
MilestoneMeal Order 1Meal Order 2
Started1515
Completed1515
Not completed00

Outcome measures

PrimaryWeighed 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.

Time frame:
Meal session 1 and 2 within 4 weeks of initial screening session
Reported as:
Mean · grams
Weighed Food Intake
gramsMeal Order 1Meal Order 2
Weighed Food Intake354.4 ± 126.2354.4 ± 126.2
Primary24-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.

Time frame:
The following day of meal session 1 and 2 within 4 weeks of initial screening session
Reported as:
Mean · grams
24-hour Dietary Recall
gramsMeal Order 1Meal Order 2
24-hour Dietary Recall302.6 ± 132.6302.6 ± 132.6

Adverse events

Collected over 4 weeks of participation. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Meal Order 10/15 (0%)0/15 (0%)0/15 (0%)
Meal Order 20/15 (0%)0/15 (0%)0/15 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Meal Order 1Meal Order 2Total
<=18 years000
Between 18 and 65 years151530
>=65 years000
Age, Continuous
Age, Continuous(years)Meal Order 1Meal Order 2Total
Mean25.3 ± 6.224.8 ± 7.125.1 ± 6.6
Sex: Female, Male
Sex: Female, Male(Participants)Meal Order 1Meal Order 2Total
Female71017
Male8513
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Meal Order 1Meal Order 2Total
American Indian or Alaska Native011
Asian12214
Native Hawaiian or Other Pacific Islander000
Black or African American000
White31114
More than one race011
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Meal Order 1Meal Order 2Total
United States151530
08

Study locations

1 site
  • Healthy Eating and Activity Laboratory, University of Tennessee
    Knoxville, Tennessee 37996, United States
09

References and documents

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 25850095 ↗
  • Sony 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 documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2017 to primary completion in Aug 2018, 12 months.

Results were first posted in Dec 2024, 6 years 4 months after primary completion.

Of 503 non-industry interventional studies with no phase under Feeding Behavior, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's 12 months is below that.

Counting every sponsor, half of 515 studies reached it within 14 months; a quarter within 5 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 10, 2017
First posted
Aug 30, 2017
StartActual
Aug 3, 2017
Primary completionActual
Aug 3, 2018
CompletionActual
Jun 3, 2020
Results first posted
Dec 9, 2024
Last update
Apr 8, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03267004
Lead sponsor
The University of Tennessee, Knoxville
Responsible party
Hollie Raynor (Faculty Advisor, The University of Tennessee, Knoxville) — Principal investigator
First posted
Aug 30, 2017
Start date
Aug 3, 2017
Primary completion
Aug 3, 2018
Completion
Jun 3, 2020
Results posted
Dec 9, 2024
Last update
Apr 8, 2025

Study contacts

Tsz-Kiu Chui
principal investigator · University of Tennessee

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion