- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06662149
Exploring the Influence of Sensory Cues on Eating Behavior Using Virtual Reality
Dining Out in NYC: Using VR to Investigate the Influence of Multisensory Urban Design Factors on Eating Behavior in Emerging Adults
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Pennsylvania
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State College, Pennsylvania, United States, 16802
- Health, Ingestive Behavior, and Technology Laboratory of Pennsylvania State University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Between the ages of 18-29
- Fluent in English
- Free of self-reported food allergies/food sensitivities
- No diagnosis of cognitive or physical disabilities/disorders that may affect appetite or eating behaviors (Examples include Major Depressive Disorder, dementia, or eating disorders)
- No diagnosis of disabilities that may affect sensory proprioception related to virtual reality (Examples include vertigo, epilepsy, and ataxia)
- Not color blind
- Does not experience anosmia (inability or weak ability to smell)
- Must have hair ≥3 cm in length at the cortisol sample site (roughly midline of the skull left to right and two inches up from the base of the hairline at the neck).
- No hair transplant in the last 6 months
Exclusion Criteria:
- Are younger than 18 or older than 29 years of age
- Not fluent in English
- Have self-reported food allergies
- Have a diagnosis of cognitive or physical disabilities that may affect appetite or eating behaviors (Examples include Major Depressive Disorder, dementia, or eating disorders)
- Have a diagnosis of disabilities that may affect sensory proprioception related to virtual reality (Examples include vertigo, epilepsy, and ataxia)
- Suffers from color blindness
- Suffers from anosmia (inability or weak ability to smell)
- Hair shorter than 3 cm in length at the cortisol sample site (roughly midline of the skull left to right and two inches up from the base of the hairline at the neck)
- Has had a hair transplant in the last 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Pleasant First
Participants will experience the pleasant smell in the participant's first visit and the unpleasant smell in the participant's second visit.
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The participants will be in an environment with an assumed pleasant smell while consuming the meal.
Participants will be in an environment with an assumed unpleasant smell while consuming the meal.
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Experimental: Unpleasant First
Participants will experience the unpleasant smell in the participant's first visit and the pleasant smell in the participant's second visit.
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The participants will be in an environment with an assumed pleasant smell while consuming the meal.
Participants will be in an environment with an assumed unpleasant smell while consuming the meal.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Food Intake Day 1
Time Frame: Measured once 5-10 minutes after the end of meal consumption
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Total weight of the meal and individual components of the meal are measured in grams before and after participant consumption.
The difference is recorded as the amount consumed by the participant.
Grams of food will be converted into kilocalories and reported as energy consumed as well.
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Measured once 5-10 minutes after the end of meal consumption
|
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Food Intake Day 2
Time Frame: Measured 5-10 minutes after the end of meal consumption
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Total weight of the meal and individual components of the meal are measured in grams before and after participant consumption.
The difference is recorded as the amount consumed by the participant.
Grams of food will be converted into kilocalories and reported as energy consumed as well.
|
Measured 5-10 minutes after the end of meal consumption
|
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Scent Experience Questionnaire (SEQ) Baseline Visit 1
Time Frame: Measured 5-10 minutes prior to entering VR environment at Visit 1
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Answered on a tablet; Participants respond to questions 1-3 using a visual analog scale with opposite descriptors on each end. Question 4 is open response that will be coded as a positive memory/scent or negative memory/scent.
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Measured 5-10 minutes prior to entering VR environment at Visit 1
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Scent Experience Questionnaire (SEQ) Baseline Visit 2
Time Frame: Measured 5-10 minutes prior to entering VR environment at Visit 2
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Answered on a tablet; Participants respond to questions 1-3 using a visual analog scale with opposite descriptors on each end. Question 4 is open response that will be coded as a positive memory/scent or negative memory/scent.
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Measured 5-10 minutes prior to entering VR environment at Visit 2
|
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Scent Experience Questionnaire (SEQ) Post-VR Visit 1
Time Frame: Measured 1-5 minutes after entering VR environment at Visit 1
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Answered on a tablet; Participants respond to questions 1-3 using a visual analog scale with opposite descriptors on each end. Question 4 is open response that will be coded as a positive memory/scent or negative memory/scent.
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Measured 1-5 minutes after entering VR environment at Visit 1
|
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Scent Experience Questionnaire (SEQ) Post-VR Visit 2
Time Frame: Measured 1-5 minutes after entering VR environment at Visit 2
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Answered on a tablet; Participants respond to questions 1-3 using a visual analog scale with opposite descriptors on each end. Question 4 is open response that will be coded as a positive memory/scent or negative memory/scent.
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Measured 1-5 minutes after entering VR environment at Visit 2
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pleasure-Arousal-Dominance (PAD) Survey Baseline Visit 1
Time Frame: Measured 5-10 minutes prior to entering VR environment at Visit 1
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Survey answered on a tablet; participant rates the following questions on a 1-9 scale, with 9 being a stronger feeling of the stated emotion.
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Measured 5-10 minutes prior to entering VR environment at Visit 1
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Pleasure-Arousal-Dominance (PAD) Survey Baseline Visit 2
Time Frame: Measured 5-10 minutes prior to entering VR environment at Visit 2
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Survey answered on a tablet; participant rates the following questions on a 1-9 scale, with 9 being a stronger feeling of the stated emotion.
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Measured 5-10 minutes prior to entering VR environment at Visit 2
|
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Pleasure-Arousal-Dominance (PAD) Survey Post VR Visit 1
Time Frame: Measured 1-5 minutes after entering VR environment at Visit 1
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Survey answered on a tablet; Participant is prompted with the following input: Imagine you are in the space you saw when wearing the headset. You are there after a long day's work. Now, how does the architectural space in the image make you feel? Scale of 1-9. A higher score indicates a stronger feeling in that dimension.
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Measured 1-5 minutes after entering VR environment at Visit 1
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Pleasure-Arousal-Dominance (PAD) Survey Post VR Visit 2
Time Frame: Measured 1-5 minutes after entering VR environment at Visit 2
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Survey answered on a tablet; Participant is prompted with the following input: Imagine you are in the space you saw when wearing the headset. You are there after a long day's work. Now, how does the architectural space in the image make you feel? Scale of 1-9. A higher score indicates a stronger feeling in that dimension.
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Measured 1-5 minutes after entering VR environment at Visit 2
|
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Positive Affect Negative Affect Survey (PANAS) Baseline Visit 1
Time Frame: Measured 5-10 minutes prior to entering VR environment at Visit 1
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Survey is taken on a tablet; Participant responds according to how much they are feeling that emotion at that moment with a 1-5 scale (1 is not at all and 5 is extremely).
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Measured 5-10 minutes prior to entering VR environment at Visit 1
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Positive Affect Negative Affect Survey (PANAS) Baseline Visit 2
Time Frame: Measured 5-10 minutes prior to entering VR environment at Visit 2
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Survey is taken on a tablet; Participant responds according to how much they are feeling that emotion at that moment with a 1-5 scale (1 is not at all and 5 is extremely).
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Measured 5-10 minutes prior to entering VR environment at Visit 2
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Positive Affect Negative Affect Survey (PANAS) Post-VR Visit 1
Time Frame: Measured 1-5 minutes after entering VR environment at Visit 1
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Survey is taken on a tablet; Participant responds according to how much they are feeling that emotion in response to the VR space with a 1-5 scale (1 is not at all and 5 is extremely).
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Measured 1-5 minutes after entering VR environment at Visit 1
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Positive Affect Negative Affect Survey (PANAS) Post-VR Visit 2
Time Frame: Measured 1-5 minutes after entering VR environment at Visit 2
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Survey is taken on a tablet; Participant responds according to how much they are feeling that emotion in response to the VR space with a 1-5 scale (1 is not at all and 5 is extremely).
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Measured 1-5 minutes after entering VR environment at Visit 2
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State Anxiety Inventory (SAI) Baseline Visit 1
Time Frame: Measured 5-10 minutes prior to entering VR environment at Visit 1
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Answered on a tablet; Read each statement and select the appropriate response to indicate how you feel right now, that is, at this very moment. Do not spend too much time on any one statement, but give the answer which seems to describe your present feelings best. Answered on a 1-4 scale: 1 Not at all 2 A little 3 Somewhat 4 Very Much So
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Measured 5-10 minutes prior to entering VR environment at Visit 1
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State Anxiety Inventory (SAI) Baseline Visit 2
Time Frame: Measured 5-10 minutes prior to entering VR environment at Visit 2
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Answered on a tablet; Read each statement and select the appropriate response to indicate how you feel right now, that is, at this very moment. Do not spend too much time on any one statement, but give the answer which seems to describe your present feelings best. Answered on a 1-4 scale: 1 Not at all 2 A little 3 Somewhat 4 Very Much So
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Measured 5-10 minutes prior to entering VR environment at Visit 2
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State Anxiety Inventory (SAI) Post-VR Visit 1
Time Frame: Measured 1-5 minutes after entering VR environment at Visit 1
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Answered on a tablet; Read each statement and select the appropriate response to indicate how you feel right now, that is, at this very moment. Do not spend too much time on any one statement, but give the answer which seems to describe your present feelings best. Answered on a 1-4 scale: 1 Not at all 2 A little 3 Somewhat 4 Very Much So
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Measured 1-5 minutes after entering VR environment at Visit 1
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State Anxiety Inventory (SAI) Post-VR Visit 2
Time Frame: Measured 1-5 minutes after entering VR environment at Visit 2
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Answered on a tablet; Read each statement and select the appropriate response to indicate how you feel right now, that is, at this very moment. Do not spend too much time on any one statement, but give the answer which seems to describe your present feelings best. Answered on a 1-4 scale: 1 Not at all 2 A little 3 Somewhat 4 Very Much So
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Measured 1-5 minutes after entering VR environment at Visit 2
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Affect and Spatial Experience Scale (ASE)
Time Frame: Measured 5-10 minutes after the end of meal consumption and VR experience at visit 1
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Answered on a tablet; Participants rate their experience with the virtual reality environment on a -10 to 10 scale with opposite descriptors on either end of the scale and 10 being the most like the stated attribute
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Measured 5-10 minutes after the end of meal consumption and VR experience at visit 1
|
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VR Presence Questionnaire Visit 1
Time Frame: Measured once 5-10 minutes after the end of meal consumption and the VR experience at visit 1
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Answered on a tablet; participants marked on a visual analog scale from 0-100 how they felt in the VR with 0 being not at all and 100 being very much
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Measured once 5-10 minutes after the end of meal consumption and the VR experience at visit 1
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VR Presence Questionnaire Visit 2
Time Frame: Measured once 5-10 minutes after the end of meal consumption and the VR experience at visit 2
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Answered on a tablet; participants marked on a visual analog scale from 0-100 how they felt in the VR with 0 being not at all and 100 being very much
|
Measured once 5-10 minutes after the end of meal consumption and the VR experience at visit 2
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VR Preference Questionnaire Visit 1
Time Frame: Measured once 5-10 minutes after the end of meal consumption and the VR experience at visit 1
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Answered on a tablet; Participants would rank on a 0-8 point scale: for question 1-None, a few minutes, half an hour, one hour, a few hours, a day, a few days, many many days; for questions 2-5-not at all, very slight, slight, slight to moderate, moderate, much, very much, extremely so
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Measured once 5-10 minutes after the end of meal consumption and the VR experience at visit 1
|
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VR Preference Questionnaire Visit 2
Time Frame: Measured once 5-10 minutes after the end of meal consumption and the VR experience at visit 2
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Answered on a tablet; Participants would rank on a 0-8 point scale: for question 1-None, a few minutes, half an hour, one hour, a few hours, a day, a few days, many many days; for questions 2-5-not at all, very slight, slight, slight to moderate, moderate, much, very much, extremely so
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Measured once 5-10 minutes after the end of meal consumption and the VR experience at visit 2
|
|
Hair Cortisol
Time Frame: Measured once 15 minutes prior to entering VR environment at Visit 1
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The 3-month concentration of cortisol in the participant's hair will be recorded in picograms per milligram--higher values mean higher stress over the past 3 months.
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Measured once 15 minutes prior to entering VR environment at Visit 1
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reasons Individuals Stop Eating Questionnaire
Time Frame: Measured once 5-10 minutes after the end of meal consumption and the VR experience at visit 2
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Answered on a tablet; participants rate on a scale from 1-7 how much each statement reflects their typical behavior Rating Scale 1, Never | 2, Rarely | 3, Seldom | 4, Sometimes | 5, Often | 6, Usually | 7, Always Prompt participants receive: Think about eating a typical dinner meal in your home. For each statement below, identify the frequency that best reflects how often you experience this as a reason that you stop eating a typical dinner at home. |
Measured once 5-10 minutes after the end of meal consumption and the VR experience at visit 2
|
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Adult Eating Behavior Questionnaire
Time Frame: Measured once 5-10 minutes after the end of meal consumption and the VR experience at visit 2
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Answered on a tablet; participants rate on a scale from 1-5 how much each statement reflects their typical behavior Rating Scale 1, Strongly disagree | 2, Disagree | 3, Neither agree or disagree | 4, Agree | 5, Strongly agree |
Measured once 5-10 minutes after the end of meal consumption and the VR experience at visit 2
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External Cue Reactivity Questionnaire
Time Frame: Measured once 5-10 minutes after the end of meal consumption and the VR experience at visit 2
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Answered on a tablet; participants rate on a scale from 1-4 how often the statement is true for them Rating Scale 1, Rarely | 2, Sometimes | 3, Often | 4, A lot Questions:
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Measured once 5-10 minutes after the end of meal consumption and the VR experience at visit 2
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Three Factor Eating Questionnaire
Time Frame: Measured once 5-10 minutes after the end of meal consumption and the VR experience at visit 2
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Answered on a tablet; participants rate on a scale from 1-4 how true the statement is for them Rating Scale 1, Definitely false | 2, Mostly false | 3, Mostly true | 4, Definitely true |
Measured once 5-10 minutes after the end of meal consumption and the VR experience at visit 2
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Engagement Questionnaire
Time Frame: Measured once 5-10 minutes after the end of meal consumption and the VR experience at visit 2
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Answered on a tablet; participants rate on a scale from 1-7 how much they agree with each statement. Questions 1-3 were reverse scored. Rating Scale 1, Strongly disagree | 2, Disagree | 3, Somewhat disagree | 4, Neutral | 5, Somewhat agree | 6, Agree | 7, Strongly agree |
Measured once 5-10 minutes after the end of meal consumption and the VR experience at visit 2
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Visual Analog Scale of Hunger and Thirst Baseline Visit 1
Time Frame: Measured 5-10 minutes prior to entering VR environment at Visit 1
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Answered on a tablet; Participants rate their hunger, thirst, fullness, and nausea on a 0-100 scale where 0 is not at all and 100 is extremely.
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Measured 5-10 minutes prior to entering VR environment at Visit 1
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Visual Analog Scale of Hunger and Thirst Baseline Visit 2
Time Frame: Measured 5-10 minutes prior to entering VR environment at Visit 2
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Answered on a tablet; Participants rate their hunger, thirst, fullness, and nausea on a 0-100 scale where 0 is not at all and 100 is extremely.
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Measured 5-10 minutes prior to entering VR environment at Visit 2
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Visual Analog Scale of Hunger and Thirst Post Visit 2
Time Frame: Measured 5-10 minutes after the end of meal consumption and VR experience at Visit 2
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Answered on a tablet; Participants rate their hunger, thirst, fullness, and nausea on a 0-100 scale where 0 is not at all and 100 is extremely.
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Measured 5-10 minutes after the end of meal consumption and VR experience at Visit 2
|
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Visual Analog Scale of Hunger and Thirst Post Visit 1
Time Frame: Measured 5-10 minutes after the end of meal consumption and VR experience at Visit 1
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Answered on a tablet; Participants rate their hunger, thirst, fullness, and nausea on a 0-100 scale where 0 is not at all and 100 is extremely.
|
Measured 5-10 minutes after the end of meal consumption and VR experience at Visit 1
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Travis Masterson, The Pennsylvania State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00025849
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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