Clinical trial NCT03267004: Dietary Assessment Study Via Digital Images
Official title: Validation Study of a Passive Image-Assisted Dietary Assessment With Automated Image Analysis Process
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet Habit
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
First posted: 2017-08-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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).
Primary purpose: SCREENING

Brief 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).

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* wear electronic medical devices such as pacemakers and implantable defibrillators

Primary outcomes:
measure: Weighed Food Intake
timeFrame: Meal session 1 and 2 within 4 weeks of initial screening session
measure: 24-hour Dietary Recall
timeFrame: The following day of meal session 1 and 2 within 4 weeks of initial screening session
Secondary outcomes:
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: Healthy Eating and Activity Laboratory, University of Tennessee
state: Tennessee
Study officials:
affiliation: University of Tennessee
name: Tsz-Kiu Chui
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Lohman TR, Roche AF, Martorell R. Anthropometric Standardization Reference Manual. Champaign,Illinois: Human Kinetics Books; 1988.
citation: 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.
citation: Sony Coporation. Smarteyeglass: API Overview. 2017; https://developer.sony.com/develop/wearables/smarteyeglass-sdk/api-overview/. Accessed Feb, 2017.
citation: 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.