ObesityNCT04078607
Cognitive Distraction on Food Intake: Randomized Crossover Exploratory Study
A study testing Rapid Visual Information Processing task in people with Obesity and Weight, Body, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Weight, Body
- What is being tested?
- Rapid Visual Information Processing task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2017to 31 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- able to read and speak English and willing to consume foods provided during the study
Who cannot join
- adhering to any dietary restrictions or diets, having any food allergies, and/or having any chronic or metabolic diseases
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Urbana-Champaign
Urbana, Illinois, 61801
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity, Weight, Body
- Being tested
- Rapid Visual Information Processing task, None or Control condition
- Keywords
- Distraction, Eating behavior, Fullness, Hunger, Ingestive behavior, Rapid visual information processing
- Medical subject headings
- Obesity, Body Weight, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid Visual Information Processing taskBehavioural
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.
None or Control conditionBehavioural
Participant were instructed to eat at will during a 15-minute duration.
| Study group | Role | What they receive |
|---|---|---|
| Distraction | Experimental | Distraction during eating using the Rapid Visual Information Processing task as the distraction Receives: Behavioral: Rapid Visual Information Processing task |
| Control | Placebo comparator | No distraction during eating Receives: Behavioral: None or Control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food intake
Consumption of food by number of food items eaten
Measured: Up to 14 days
Secondary outcomes (5)
Snack intake
Consumption of snack choices by number of food items eaten
Measured: Up to 14 days
Memory of food intake
Recording of food that was eaten during the condition period by number of food items eaten
Measured: Up to 14 days
Fullness
How full do you feel right now? by 100mm visual analog scale; 0=not at all to 100=very much
Measured: Up to 14 days
Hunger
How hungry do you feel right now? by 100mm visual analog scale; 0=not at all to 100=very much
Measured: Up to 14 days
Enjoyment
How much did you enjoy the meal provided? by 100mm visual analog scale; 0=not at all to 100=very much
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start1 Jan 2017
- Primary completion30 Apr 2017
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized controlled crossover study where participants were assigned to begin in the distracted or control condition. One week later, participants completed the opposite condition.
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shelly Nickols-Richardson, University of Illinois at Urbana-Champaign
- Investigators
- Shelly Nickols-Richardson, PhD, Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078607
- Sponsor's protocol ID
- liguori
- Status last verified
- Sep 2019
- First submitted
- 18 Aug 2019
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared if required by journal requirements and/or as requested by other researchers
Publications
Liguori CA, Nikolaus CJ, Nickols-Richardson SM. Cognitive Distraction at Mealtime Decreases Amount Consumed in Healthy Young Adults: A Randomized Crossover Exploratory Study. J Nutr. 2020 May 1;150(5):1324-1329. doi: 10.1093/jn/nxaa022.
PubMed 32060552
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Cognitive Distraction on Amount, Preference, and Memory of Food Consumed: a Randomized Crossover Exploratory Study
- ClinicalTrials.gov ID
- NCT04078607
- Acronym / sponsor ID
- liguori
- Conditions
- Obesity, Weight, Body
- Keywords
- Distraction, Eating behavior, Fullness, Hunger, Ingestive behavior, Rapid visual information processing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled crossover study where participants were assigned to begin in the distracted or control condition. One week later, participants completed the opposite condition.
| Arm | Type | Receives |
|---|---|---|
| Distraction | Experimental | Behavioral: Rapid Visual Information Processing taskDistraction during eating using the Rapid Visual Information Processing task as the distraction |
| Control | Placebo comparator | Behavioral: None or Control conditionNo distraction during eating |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- able to read and speak English and willing to consume foods provided during the study
Key exclusion criteria (1 listed)
- adhering to any dietary restrictions or diets, having any food allergies, and/or having any chronic or metabolic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid Visual Information Processing taskA 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. | Behavioural | Distraction |
| None or Control conditionParticipant were instructed to eat at will during a 15-minute duration. | Behavioural | Control |
Primary outcome
Food intake
Time frame: Up to 14 days
Consumption of food by number of food items eaten
5 secondary outcomes
Snack intake
Time frame: Up to 14 days
Memory of food intake
Time frame: Up to 14 days
Fullness
Time frame: Up to 14 days
Hunger
Time frame: Up to 14 days
Enjoyment
Time frame: Up to 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Derived from this study: PubMed 32060552Liguori CA, Nikolaus CJ, Nickols-Richardson SM. Cognitive Distraction at Mealtime Decreases Amount Consumed in Healthy Young Adults: A Randomized Crossover Exploratory Study. J Nutr. 2020 May 1;150(5):1324-1329. doi: 10.1093/jn/nxaa022.
- Individual participant dataSharing planned: Yes. De-identified data will be shared if required by journal requirements and/or as requested by other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shelly Nickols-Richardson, PhD principal investigator
University of Illinois at Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid Visual Information Processing task in people with Obesity and Weight, Body, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food intake (time frame: Up to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04078607, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.