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临床试验/NCT03407352
NCT03407352已完成不适用

Response Inhibition to High Calorie Food Cues Among Adolescents Following Active and Sedentary Video Game Play Using a Go/No-Go Task: A Randomized Crossover Study

Brigham Young University2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2016年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
65
试验地点
2
主要终点
Response inhibition

研究概览

简要总结

Response inhibition is a cognitive process that helps individuals suppress or avoid unwanted actions and inappropriate behavior. In regards to food, response inhibition allows a person to resist eating, ignore poor food choices and poor behavior related to food choices. Previous research suggests that physical activity may play a role in the regulation of response inhibition to food in adults.

The purpose of this study is to compare the effects of an acute bout of active video gaming versus passive video gaming on response inhibition to high calorie and low calorie food images among adolescents.

The proposed study is a randomized cross-over study with counterbalanced design. Participants will come to the lab two times. Each subject will serve as their own control. There will be two conditions and all participants will complete both conditions. One condition will be completed each time the participants come to the lab. The two conditions will include (a) 60 minutes of sedentary video game play and (b) 60 minutes of active video game play at moderate-intense levels. After each video game condition the participants will view pictures of high-calorie and low-calorie foods while being connected to an EEG machine. The EEG will measure the N2 and P3 event-related potentials, which will be used to index and analyze response inhibition. As participants view the pictures of high-calorie and low-calorie foods, they will be given a button pressing task where the press a button when they see pictures of the high-calorie or low-calorie foods. Immediately after each video game session participants will complete two cognitive measurement tasks. These tasks are (a) Stroop color-word task and (b) auditory verbal learning test. The Stroop color-word test requires the participants to read words typed in different colors on a sheet of paper and to say the name of the color of ink the words are printed in (ie to say "blue" when the word "red" is printed in blue ink). The auditory verbal learning test will require the researchers to read a list of 15 words and have participants repeat as many of the words back to the researcher as possible. This will be repeated 6 times. After the 5th time, there will be a 30 minute waiting period before the 6th trial where participants will be allowed to eat ad libitum pre-weighed foods while they wait to complete the last trial of the verbal learning test.

详细描述

Design. A randomized crossover design with counterbalanced treatment conditions will be used to compare the amount of neural inhibition to high and low calorie food cues among adolescents between two conditions. These two conditions will include a 60-minute session of active video game play and a 60-minute session of sedentary video game play. The order of treatment conditions will be randomly assigned using a validated simple randomization technique. During each laboratory session EEG data will be recorded and then later analyzed to assess the individual event related potential (ERP) components following each of the two conditions. Participants will complete a go/no-go response inhibition viewing task with pictures of high calorie and low calorie foods displayed on a computer monitor. The response inhibition task will be administered immediately following the cessation of each video game condition.

Video gaming conditions. The sedentary video game play condition will require participants to play in a seated position for 60 minutes. The active video game play condition will require participants to complete 60 minutes of active video gaming at moderate intense levels (3.0-5.9 metabolic equivalents (METs)) using a popular dance simulation game called 'Dance Dance Revolution' (DDR by Konami Digital Entertainment, Redwood City, CA). DDR elicits moderate intense (3.0-5.9 METs) levels of physical activity. Sixty minutes of active video game play has been shown to produce moderate intense levels of physical activity. Current guidelines recommend adolescents engage daily in 60 minutes or more of moderate-to vigorous-intense physical activity.

Participants. Sixty two healthy adolescents (31 female and 31 male) will be recruited through advertisements and fliers in the local community. Participants will be adolescents between the ages of 12 and 15 years old.

Procedures Screening. Candidates for the study and their guardians will be sent an email containing a link to an online survey. The online survey will be a 'yes or no' questionnaire to ensure participants meet inclusion criteria. Candidates must answer each question properly in order to qualify for the study. As part of the online survey, participants will be asked to report any food allergies and complete a food preference questionnaire. The food preference questionnaire will be used to prepare the standardized meals for each participant. Qualifying candidates will be invited to participate in the study.

Orientation. Participants for the study will be asked to complete the assent and consent forms prior to the first lab session. Participants and their guardians will come to the Clinical Neuroscience lab at least one day prior to their first lab session to pick up their standardized meals. Each participant will be informed of the main purpose of the study and familiarized with the testing procedures. Participants will be instructed to avoid consuming caffeine and other stimulants on the testing day as well as avoiding vigorous-intense physical activity for the 24-hour period prior to testing. Participants will be given a copy of these testing instructions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
12 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Participants must have normal or corrected to normal vision. Participants must be able to participate in moderate-intensity physical activity without restrictions as measured by a physical activity readiness questionnaire (PAR-Q).

排除标准

  • Participants will be excluded if they do not provide proper assent and written consent from guardians, have chronic or metabolic disease, have orthopedic impairments, have been diagnosed with an eating disorder (ie anorexia, bulimia or binge eating disorder), take medications that alter metabolism, appetite or neurological function, have a diagnosed learning disability, neurological disorder, brain injury or attention deficit/hyperactive disorder or have food allergies.

研究组 & 干预措施

Passive Video Game Play

Active Comparator

Participants will play video games in a seated position for 60 minutes.

干预措施: Passive Video Game Play (Behavioral)

Active Video Game Play

Experimental

Participants will play dance dance revolution (video game that requires lower body movement) for 60 minutes.

干预措施: Active Video Game Play (Behavioral)

结局指标

主要结局

Response inhibition

时间窗: Immediately within 15 minutes post intervention

Electrical activity of the brain will be recorded using EEG techniques using the Electrical Geodesics amplifier system (EGI: Electrical Geodesics Inc, Eugene OR) during the Go/No Go tasks. The EEG will be recorded continuously with a sampling rate of 250 Hz using a 24-bit analog-to-digital converter. The vertex sensor will be used as the reference electrode. Impedances will be kept below 50 kΩ according to EGI guidelines. A right posterior electrode approximately two inches behind the right mastoid will serve as the common ground. Electroencephalographic data will be segmented off-line and single trial epochs rejected if voltages exceed 100 µV, transitional (sample-to-sample) thresholds were greater than 100 µV or eye-channel amplitudes were above 70 µV. Data will be digitally re-referenced to an average reference then digitally low-pass filtered at 30Hz.

次要结局

  • Memory(Within 45 minutes post intervention)
  • Hunger(Before and immediately after the intervention)
  • Executive Function(Within 15 minutes post intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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