Dietary Assessment Study Via Digital Images
Validation Study of a Passive Image-Assisted Dietary Assessment With Automated Image Analysis Process
研究概览
地位
条件
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Tennessee
-
Knoxville、Tennessee、美国、37996
- Healthy Eating and Activity Laboratory, University of Tennessee
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:放映
- 分配:随机化
- 介入模型:阶乘赋值
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Meal Order 1
Meal A will be served to participant in meal session 1 and Meal B in meal session 2.
|
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)]. 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)]. |
实验性的:Meal Order 2
Meal B will be served to participant in meal session 1 and Meal A in meal session 2.
|
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)]. 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)]. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Weighed Food Intake
大体时间: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.
|
Meal session 1 and 2 within 4 weeks of initial screening session
|
DietCam
大体时间:Meal session 1 and 2 within 4 weeks of initial screening session
|
DietCam is developed by Dr. JinDong Tan and colleagues and is an application designed to automatically recognize foods and estimate volumes of a meal from images or videos without any reference objects.
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.
Assessing weight change of food intake.
|
Meal session 1 and 2 within 4 weeks of initial screening session
|
24-hour Dietary Recall
大体时间: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.
|
The following day of meal session 1 and 2 within 4 weeks of initial screening session
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Sony Smarteyeglass
大体时间:During Meal session 1 and 2 within 4 weeks of initial screening session
|
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.
|
During Meal session 1 and 2 within 4 weeks of initial screening session
|
Participants' Feedback
大体时间:Meal session 2 within 4 weeks of initial screening session
|
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.
|
Meal session 2 within 4 weeks of initial screening session
|
合作者和调查者
调查人员
- 首席研究员:Tsz-Kiu Chui、University of Tennessee
出版物和有用的链接
一般刊物
- Lohman TR, Roche AF, Martorell R. Anthropometric Standardization Reference Manual. Champaign,Illinois: Human Kinetics Books; 1988.
- 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.
- 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.
- 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.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- UTK IRB-17-03829-XP
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.