Validation Study of a Passive Image-Assisted Dietary Assessment With Automated Image Analysis Process
Phase: NA
Conditions: Diet Habit
Sponsor: The University of Tennessee, Knoxville

Validation Study of a Passive Image-Assisted Dietary Assessment With Automated Image Analysis 
Process   
NCT03267004 
5/21/24 

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11.0
(925) Study/Project Synopsis
11.1  
Click on the bar below and provide a synopsis of the research study addressing the following FOUR
*
items 
.
USING these numbered subheadings  Please be sure to provide enough detail that the IRB
understands clearly what you propose to do, with whom, and why.
Purpose/Objectives of the Study
Study Population (including any inclusion/exclusion criteria)
Study Procedures, and
Planned Analyses
1. PROJECT OBJECTIVES
Background and Specific Aims
Dietary assessment is used to determine the nutrient intake of individuals and groups.  Accurate
1
dietary assessment is essential to nutrition research to understand how diet impacts health.2
Currently, there is no gold standard or single method of dietary assessment that is applicable for
all nutrition research questions, as the purpose, population of interest, and resources available in
any investigation impact the method of assessment that can be implemented.1
The current dietary assessment methods have limitations that can affect accuracy of dietary
data. Currently, subjective dietary assessment methods are widely used in research. However,
these subjective methods are prone to errors due to issues of accuracy of capturing all foods and
beverages consumed as a consequence of recall errors and determining portion sizes of foods
and beverages consumed due to poor estimation or inaccurate measurements.
 Self-reported
,
3 4
dietary data also appears to have a systematic bias, in which populations with obesity are more
likely to underreport intake.
 Subjective methods are also labor-intensive in regards to data
5-12
collection and/or analysis.
 Objective dietary assessment can limit human errors and provide 
,
1 13
objective dietary information. However, few objective methods are available in free-living 
situations, and objective methods can be costly and difficult to use in studies with large samples.1
 The incorporation of technology into dietary assessment, such as image-assisted dietary 
,
,
13 14
assessment, has been investigated by researchers to improve accuracy in collecting dietary 
information in free-living situations.
 The active dietary assessment methods, which is self-
15
administered and requires individuals to manually capture images or videos with digital cameras, 
smartphones, and other devices with picture-capturing function,
 had improved accuracy and 
15
provided comparable accuracy of dietary information when compared with objective dietary 

assessment methods.
 However, the active dietary assessment methods still rely on humans 
,
16 17
to manually capture images, which does not eliminate human errors. Passive dietary assessment 
methods, which images or videos automatically capture dietary intake through the use of 
wearable devices or other tools, can reduce human errors as the process of collecting dietary 
information by reducing the effort and training needed to obtain imagery.
 The results of 
15
reviewed passive dietary assessment methods showed improved accuracy in assessing dietary 
information.
 However, all the image-assisted dietary assessment methodologies at this 
18-21
time involve manual image analysis processes, which increases cost. Thus, there is a need for a 
wearable device that has the function of passive image capturing, with complete automated 
image analysis software to provide accurate and inexpensive dietary information.
Therefore, 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. The specific aims 
of this investigation are: 1) to determine the accuracy of DietCam in identifying foods in different 
shapes (Regular vs Irregular) and complexities (Single food vs Mixed food); and 2) to determine 
the accuracy of DietCam to estimate food volumes comparing with weighed food intake 
measured from plate waste method.
2. STUDY POPULATION
Study Design
To validate the accuracy of DietCam in analyzing food images taken by Sony Smarteyeglass in
food recognition and volume estimation, 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 [WFI], and 24-hour dietary
recall) (see Table 1). Individuals will be randomized into one of the two orders of meals. 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). Dependent variables will be the identification
of foods and amount of foods consumed.
Table 1. Description of Study Design
Order
Meal Session 1
Meal Session 2
1 (n=15)
Meal A:
Turkey & Provolone Cheese Sandwich
(
)
Regular-shaped mixed food
Chicken and Wild Rice
(
)
Irregular-shaped mixed food
 
Chocolate Chips Cookie
(
)
Regular-shaped single food
Potato Chips Original
(
)
Irregular-shaped single food
Meal B:
Ham and Cheddar Cheese Wrap
(
)
Regular-shaped mixed food
Pasta with Broccoli in Alfredo Sauce
(
)
Irregular-shaped mixed food
Red Seedless Grapes 
(
)
Regular-shaped single food
Chocolate Ice-cream
(
)
Irregular-shaped single food
2 (n=15)
Meal B:
Ham and Cheddar Cheese Wrap
(
)
Regular-shaped mixed food
Pasta with Broccoli in Alfredo Sauce
(
)
Irregular-shaped mixed food
Red Seedless Grapes 
(
)
Regular-shaped single food
Chocolate Ice-cream
(
)
Irregular-shaped single food
Meal A:
Turkey & Provolone Cheese Sandwich
(
)
Regular-shaped mixed food
Chicken and Wild Rice
(
)
Irregular-shaped mixed food
Chocolate Chips Cookie
(
)
Regular-shaped single food
Potato Chips Original
(
)
Irregular-shaped single food
Participants
Thirty men and women will be invited to participate in the validation study. Eligibility of this 
investigation will be based upon the following criteria: 1) between the ages of 18 and 65 years; 
2) body mass index (BMI) 18.5 to 24.9 kg/m
3) no food allergies/intolerance to foods used in
2;  
the investigation; 4) report not having a dietary plan or dietary restrictions that prevents
consumption of the foods used in the investigation; 5) report a favorable preference for the
foods served in the meal (listed in Table 2), with participants rate each food item ³ 3 on a Likert

scale during the phone screen; 6) able to complete all two meal sessions within four weeks of 
the screening session; 7) are not legally blind without corrected lenses; and 8) are able to eat a 
meal while wearing the Sony Smarteyeglass. Participants will be excluded if they wear electronic 
medical devices such as pacemakers and implantable defibrillators. 
Recruitment
Participants will be recruited from the University of Tennessee, Knoxville campus by posting 
flyers around campus and handing out flyers around campus and sending emails through 
University electronic mailing lists. Participants will be asked to contact the Healthy Eating and 
Activity Laboratory (HEAL) by phone and will be given information about a study that 
investigates dietary assessment via digital images. Interested participants will be screened over 
the phone and scheduled for a face-to-face screening session. Participants who sign the consent 
form at the screening session and meet eligibility criteria will be randomized to one of two orders.
3. STUDY PROCEDURES
Procedures
All participants will be asked to come to HEAL 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 described in Table 1, 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. The second meal
session will follow the same procedure as the first session.
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.
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. After the second session is completed,
the participants will be thanked for their participation and given a $20 gift card to compensate
for their time in the study.
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 (see Table 2 for detailed description of 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 described in Table 3. 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
22
approximately 1225 kcal for males and 950 kcal for females. Each food will provide
approximately 25% of the energy for each meal.
Table 2. Detailed Description of Provided Foods
Food
Brand
Servi
ng
Calories per 
Serving
Calories per 
Gram
Cookie
Nabisco Chips Ahoy! Original
33g
160
4.85

Grapes
Red Seedless Grapes
161g
104
0.65
Potato chips
Food Club Classic Potato Chips
28g
160
5.71
Ice-cream
Blue Bell Dutch Chocolate
72g
160
2.22
Chicken
Tysonâ Fully Cooked Chicken Breast 
Fillets
98g
110
1.12
Wild Rice
Minute Ready-to-serve Brown & Wild 
Rice
125g
230
1.84
Sandwich 
Bread
Nature’s Ownâ 100% whole wheat 
bread
26g
60
2.30
Turkey Deli
Oscar Mayer Delifresh Smoked Turkey 
Breast
56g
50
0.89
Provolone 
Cheese
Food Club Not Smoked Provolone 
Cheese
23g
80
3.48
Tomato
Fresh Tomato Medium
50g
8
0.16
Lettuce
Fresh Lettuce
75g
6
0.08
Tortilla
OLE Mexican Foods High Fiber Low 
Carbs Tortilla
45g
50
1.11
Ham Deli
Oscar Mayer Delifresh Smoked Ham
56g
50
0.89
Cheddar 
Cheese
Food Club Mild Cheddar Cheese (Thin 
Sliced)
32g
130
4.06
Spring Mix
Fresh Spring Mix
142g
35
0.25
Dressing
Food Club Fat Free Ranch Dressing
29g
25
0.85
Pasta
Barilla Ready Pasta Fully Cooked Penne 121g
210
1.74
Broccoli
Food Club Broccoli Spears
89g
30
0.34
Alfredo Sauce Ragu Classic Alfredo
61g
90
1.48
Table 3. Detailed description of meal sessions
Me
als
Food
Female
Male
Amount 
Served
Calories 
Served
Amount 
Served
Calories 
Served
A
Turkey & Provolone 
Cheese Sandwich
Whole Wheat 
Bread
52g
120
52g
120
Turkey
70g
62
133g
118
Provolone 
Cheese
23g
80
23g
80
Tomato
50g
8
50g
8
Lettuce
45g
4
45g
4
Total:
240g
274
303g
330
Chicken and Wild Rice
Chicken
98g
110
98g
110
Wild Rice
71g
131
107g
197
Total:
169g
241
205g
307
Chocolate Chips Cookies
44g
213
60.5g
293
Potato chips Original
39g
223
52g
297
Total Meal A Calories
951
1227
B
Ham and Cheddar Cheese 
Wrap
Tortilla
45g
50
45g
50
Ham Deli
76g
68
103
92
Cheddar 
Cheese
21g
85
32g
130
Spring Mix
36g
9
36
9
FF Ranch 
Dressing
29g
25
29g
25
Total:
207g
237
247g
306
Pasta with Broccoli and 
Alfredo Sauce
Pasta
91g
158
121g
210
Broccoli
66g
22
66g
22
Alfredo Sauce 38g
56
50g
74
Total:
195g
236
237g
306
Chocolate Ice-cream
107g
238
138g
306
Red Seedless Grapes
365g
237
471g
306
Total Meal B Calories
948
1224
Measures
All measures will be collected at HEAL by trained research assistants.

Anthropometrics: Weight, height, and BMI- During the initial phone screen height and weight will 
be asked by the phone screener and BMI calculated from those values. During the initial 
screening session, weight will be assessed by an electronic scale, and height will be assessed 
using a stadiometer, using standard procedures, with participants wearing light clothing, without 
shoes.23  BMI (kg/m2) will be calculated from these measures. A BMI between 18.5 and 24.9 is 
required to be eligible for this study.
Demographics- At the initial screening session, basic demographic information (e.g., gender, 
age, education level) will be obtained.
Sony Smarteyeglass – Digital images will be recorded during each meal session using Sony 
Smarteyeglass. Number of blurred images and times that Sony Smarteyeglass fail to capturing 
images will be documented.
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. The weight of the containers will also 
be measured. The total grams of each food items will be recorded and total food consumed will 
be calculated by subtracting plate waste weight from the pre-meal weight. Results of total grams 
of each food items and total food consumed will be entered into Nutrition Data System for 
Research (NDS-R) dietary software developed by the Nutrition Coordinating Center, University of 
Minnesota, Minneapolis, Minnesota.
DietCam- DietCam is developed by Dr. JinDong Tan and colleagues24 and is an application 
designed to automatically recognize foods and estimate volumes of a meal from images or 
videos. DietCam has an algorithm called multi-view food classification that recognizes foods and 
beverages in images or videos and estimates volumes without any reference objects.24 DietCam 
has the average accuracy rate of 84% in recognizing regular shape food items.24 DietCam will 
be used to analysis digitial images taken by the Sony Smarteyeglass in the study to identify food 
items and estimate volumes of food intake. In this investigation, DietCam will be used to identify 
food items with different shapes (Regular vs Irregular) and complexities (Single food vs Mixed 
food).  DietCam will also be used to estimate volume of foods in the unit of cubic meters (m3). 
Results of volume estimation of foods from DietCam will be entered to NDS-R to convert to 
commonly used measurements.
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. 
Participants’ Feedback- At the end of last meal session, participants will be asked to complete a 
questionnaire regarding their experience on using Sony Smarteyeglass. A total of six structured 
questions will be included in the questionnaire and each question will be associated with an open-
ended question. Structured questions will consist of a five-scale rating regarding ease of use, 
clearness of instructions, satisfaction, likelihood, and comfortableness. Percentages of 
participants answering in responses to each structured question will be tabulated and open-
ended questions will be summarized.