NCT04078607

Brief 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. A randomized controlled crossover study of 119 healthy adults, assigned to begin in either the distracted or control condition, was conducted.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2017

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2019

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

4 months

First QC Date

August 18, 2019

Last Update Submit

September 1, 2019

Conditions

Keywords

DistractionEating behaviorFullnessHungerIngestive behaviorRapid visual information processing

Outcome Measures

Primary Outcomes (1)

  • Food intake

    Consumption of food by number of food items eaten

    Up to 14 days

Secondary Outcomes (5)

  • Snack intake

    Up to 14 days

  • Memory of food intake

    Up to 14 days

  • Fullness

    Up to 14 days

  • Hunger

    Up to 14 days

  • Enjoyment

    Up to 14 days

Study Arms (2)

Distraction

EXPERIMENTAL

Distraction during eating using the Rapid Visual Information Processing task as the distraction

Behavioral: Rapid Visual Information Processing task

Control

PLACEBO COMPARATOR

No distraction during eating

Behavioral: None or Control condition

Interventions

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.

Distraction

Participant were instructed to eat at will during a 15-minute duration.

Control

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • able to read and speak English and willing to consume foods provided during the study

You may not qualify if:

  • adhering to any dietary restrictions or diets, having any food allergies, and/or having any chronic or metabolic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

ObesityBody WeightFeeding Behavior

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AnimalBehavior

Study Officials

  • Shelly Nickols-Richardson, PhD

    University of Illinois at Urbana-Champaign

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Randomized controlled crossover study where participants were assigned to begin in the distracted or control condition. One week later, participants completed the opposite condition.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 18, 2019

First Posted

September 6, 2019

Study Start

January 1, 2017

Primary Completion

April 30, 2017

Study Completion

May 31, 2018

Last Updated

September 6, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share

De-identified data will be shared if required by journal requirements and/or as requested by other researchers

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Immediately until after publication of study
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

Locations