NCT03337633

Brief Summary

High cognitive load activities can influence energy intake from food. It is unknown how restaurant menu designs may affect patrons in terms of cognitive demand and subsequent ordering of food.Objective: Our objective was to develop and experimentally test menu designs that differ in cognitive load to test the subjective and objective stress measures on food ordering.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

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

April 1, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2015

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 9, 2017

Completed
Last Updated

November 9, 2017

Status Verified

November 1, 2017

Enrollment Period

12 months

First QC Date

October 18, 2017

Last Update Submit

November 6, 2017

Conditions

Keywords

cognitive loadgalvanic skin responsemeal sizekilocaloriesmenu design

Outcome Measures

Primary Outcomes (2)

  • Total Number of Items Ordered

    Total number of items ordered off assigned menu

    During the 5-minute menu ordering task

  • Total Energy of Items ordered

    Total Energy (kcals) of items ordered off assigned menu

    During the 5-minute menu ordering task

Secondary Outcomes (2)

  • Subjective ratings of difficulty of using assigned menu to order a meal

    Immediately (1 minute) following the 5-minute menu ordering period

  • Galvanic Skin Response

    During the 5-minute menu ordering task

Study Arms (4)

Experiment 1 Easy

ACTIVE COMPARATOR

For the first experiment, subjects in this arm received the "easy" menu during the protocol.

Behavioral: Menu design

Experiment 1 Hard

ACTIVE COMPARATOR

For the first experiment, subjects in this arm received the "hard" menu during the protocol.

Behavioral: Menu design

Experiment 2 Easy

ACTIVE COMPARATOR

For the second experiment, subjects in this arm, who qualified as restrained eaters and were asked to fast for 8 hours overnight, received the "easy" menu during the protocol.

Behavioral: Menu design

Experiment 2 Hard

ACTIVE COMPARATOR

For the second experiment, subjects in this arm, who qualified as restrained eaters and were asked to fast for 8 hours overnight, received the "hard" menu during the protocol.

Behavioral: Menu design

Interventions

Menu designBEHAVIORAL

Participants were given 5 minutes to order a hypothetical meal from the assigned test menu by circling all items they wanted to order.

Experiment 1 EasyExperiment 1 HardExperiment 2 EasyExperiment 2 Hard

Eligibility Criteria

Age19 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normal vision or corrective lenses
  • Normal hearing or a hearing aid
  • A moderate level of English proficiency or greater
  • Free from current food restrictions

You may not qualify if:

  • Unwilling/uninterested in participation
  • Currently taking any β-blocker medications
  • Any serious skin conditions on the hands (because of galvanic skin sensors worn for the protocol)
  • Experiment 2
  • Normal vision or corrective lenses
  • Normal hearing or a hearing aid
  • A moderate level of English proficiency or greater
  • Free from current food restrictions
  • Qualifying as a restrained eater by the Cognitive Restraint scale on the Eating Inventory (score of 6 for men and 10 for women)
  • Unwilling/uninterested in participation
  • Currently taking any β-blocker medications
  • Any serious skin conditions on the hands (because of galvanic skin sensors worn for the protocol)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Food Preferences

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Kathryn A Kaiser, PhD

    University of Alabama at Birmingham, Asst. Professor, Dept of Health Behavior

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were blinded to treatment allocation.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Parallel arm randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 18, 2017

First Posted

November 9, 2017

Study Start

April 1, 2014

Primary Completion

March 20, 2015

Study Completion

March 20, 2015

Last Updated

November 9, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will share

Pending approval by the University of Alabama at Birmingham's Institutional Review Board (IRB), which we have received for other studies and anticipate receiving here, we will prepare transportable de-identified raw databases and codebooks, which will contain the raw data used in any paper we publish from the proposed research. We will publically deposit such raw data for access by others without restriction in a public repository such as ICPSR. For any investigator requesting data we have not yet published, we will be glad to provide de-identified data and codebooks to the investigators provided that the proposed use does not conflict with our intentions for use.

Shared Documents
ICF, ANALYTIC CODE
Time Frame
Materials will be posted after publication of study results.
Access Criteria
Data and supporting materials will be freely available to anyone with access to openICPSR.