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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03337633
Other study ID # X140313004
Secondary ID
Status Completed
Phase N/A
First received October 18, 2017
Last updated November 6, 2017
Start date April 1, 2014
Est. completion date March 20, 2015

Study information

Verified date November 2017
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

For the first experiment, a parallel randomized trial of healthy young adults (n= 30) was conducted to compare ordering from one of two menu designs (easy - E, hard - H) developed in a prior pilot study. In the second experiment, restrained eaters were specifically recruited and asked to fast before the experiment to determine the influence of cognitive load of menus on energy ordered (n=31). Galvanic skin response was used as an objective proxy for relative cognitive load, and questionnaires were used to assess perceptions of the menus. The main outcomes were the number of items ordered and total energy of the items ordered (in kilocalories).


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date March 20, 2015
Est. primary completion date March 20, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 35 Years
Eligibility Experiment 1

Inclusion Criteria:

- Normal vision or corrective lenses

- Normal hearing or a hearing aid

- A moderate level of English proficiency or greater

- Free from current food restrictions

Exclusion Criteria:

- Unwilling/uninterested in participation

- Currently taking any ß-blocker medications

- Any serious skin conditions on the hands (because of galvanic skin sensors worn for the protocol)

Experiment 2

Inclusion Criteria:

- 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)

Exclusion Criteria:

- Unwilling/uninterested in participation

- Currently taking any ß-blocker medications

- Any serious skin conditions on the hands (because of galvanic skin sensors worn for the protocol)

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Alabama at Birmingham Texas Tech University

Outcome

Type Measure Description Time frame Safety issue
Primary Total Number of Items Ordered Total number of items ordered off assigned menu During the 5-minute menu ordering task
Primary Total Energy of Items ordered Total Energy (kcals) of items ordered off assigned menu During the 5-minute menu ordering task
Secondary Subjective ratings of difficulty of using assigned menu to order a meal Assessed by NASA Task Load Index questionnaire Immediately (1 minute) following the 5-minute menu ordering period
Secondary Galvanic Skin Response An objective proxy for relative cognitive load; this measure has been shown to be positively correlated with psychological stress or cognitive challenge as mediated by sympathetic nervous system activity During the 5-minute menu ordering task
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