- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04078607
Cognitive Distraction on Food Intake: Randomized Crossover Exploratory Study
September 1, 2019 updated by: Shelly Nickols-Richardson, University of Illinois at Urbana-Champaign
Effect of a Cognitive Distraction on Amount, Preference, and Memory of Food Consumed: a Randomized Crossover Exploratory Study
This study determined effects of a cognitive distraction on amount, preference, and memory of food consumed and perceptions of fullness, hunger, and enjoyment of food in a healthy young-adult population.
A randomized controlled crossover study of 119 healthy adults, assigned to begin in either the distracted or control condition, was conducted.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Environmental distractions have been shown to affect eating patterns.
Influences of food environments on consumption patterns and not simply food choices are becoming increasingly clear for their contributions to energy intake.
Of particular interest is the presence of distraction.
It has been postulated that when distracted, individuals are inclined to consumer more than when not distracted.
However, how distraction and memory impact subsequent food choice and preference is less well known.
A Rapid Visual Information Processing (RVIP) task was applied to distract individuals while eating; food intake and food behaviors were measured after RVIP distraction and compared to food intake and food behaviors without distraction in the same individuals.
Study Type
Interventional
Enrollment (Actual)
119
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Urbana, Illinois, United States, 61801
- University of Illinois at Urbana-Champaign
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 23 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- able to read and speak English and willing to consume foods provided during the study
Exclusion Criteria:
- adhering to any dietary restrictions or diets, having any food allergies, and/or having any chronic or metabolic diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Distraction
Distraction during eating using the Rapid Visual Information Processing task as the distraction
|
A series of numbers appeared on a computer screen at a rate of one per minute.
Each participant was required to identify any series of three consecutive odd or even numbers by hitting the space bar on the keyboard.
The task lasted 15 minutes and included a 1-minute practice session before food being served.
Participants were instructed to eat at will while completing the computer task.
|
Placebo Comparator: Control
No distraction during eating
|
Participant were instructed to eat at will during a 15-minute duration.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Food intake
Time Frame: Up to 14 days
|
Consumption of food by number of food items eaten
|
Up to 14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Snack intake
Time Frame: Up to 14 days
|
Consumption of snack choices by number of food items eaten
|
Up to 14 days
|
Memory of food intake
Time Frame: Up to 14 days
|
Recording of food that was eaten during the condition period by number of food items eaten
|
Up to 14 days
|
Fullness
Time Frame: Up to 14 days
|
How full do you feel right now? by 100mm visual analog scale; 0=not at all to 100=very much
|
Up to 14 days
|
Hunger
Time Frame: Up to 14 days
|
How hungry do you feel right now? by 100mm visual analog scale; 0=not at all to 100=very much
|
Up to 14 days
|
Enjoyment
Time Frame: Up to 14 days
|
How much did you enjoy the meal provided?
by 100mm visual analog scale; 0=not at all to 100=very much
|
Up to 14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Shelly Nickols-Richardson, PhD, University of Illinois at Urbana-Champaign
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Actual)
April 30, 2017
Study Completion (Actual)
May 31, 2018
Study Registration Dates
First Submitted
August 18, 2019
First Submitted That Met QC Criteria
September 1, 2019
First Posted (Actual)
September 6, 2019
Study Record Updates
Last Update Posted (Actual)
September 6, 2019
Last Update Submitted That Met QC Criteria
September 1, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- liguori
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
De-identified data will be shared if required by journal requirements and/or as requested by other researchers
IPD Sharing Time Frame
Immediately until after publication of study
IPD Sharing Access Criteria
Contact with the primary investigator using criteria of co-publishing, collaborating on same topic, or using data as preliminary findings for further studies; primary investigator will review requests
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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