NCT02804503

Brief Summary

Most studies on menu labels have been conducted in mostly non-Hispanic white individuals, and how menu labels affect calories and macronutrients ordered in Hispanics is not clearly understood. This study evaluated the impact of menu labels on calories and macronutrients ordered in Hispanics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
372

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

Shorter than P25 for not_applicable

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

November 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 14, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
Last Updated

June 17, 2016

Status Verified

June 1, 2016

Enrollment Period

7 months

First QC Date

June 14, 2016

Last Update Submit

June 14, 2016

Conditions

Food Selection

Outcome Measures

Primary Outcomes (1)

  • Calories Ordered

    Calories content of the food items ordered from the assigned menu was calculated.

    20-30 minutes

Secondary Outcomes (1)

  • Macronutrients ordered

    20-30 minutes

Study Arms (3)

Calorie Labels

EXPERIMENTAL

A menu with rank ordered calorie labels and a statement on the energy needs per meal.

Behavioral: Calorie Labels

Exercise Labels

EXPERIMENTAL

A menu with rank ordered exercise labels showing minutes of brisk walking necessary to burn the food calories.

Behavioral: Exercise Labels

No Labels

ACTIVE COMPARATOR

A menu with no labels

Behavioral: No Labels

Interventions

Calorie LabelsBEHAVIORAL

Participants were asked to order food from the assigned menu as if they were having lunch in a fast food restaurant.

Calorie Labels
Exercise LabelsBEHAVIORAL

Participants were asked to order food from the assigned menu as if they were having lunch in a fast food restaurant.

Exercise Labels
No LabelsBEHAVIORAL

Participants were asked to order food from the assigned menu as if they were having lunch in a fast food restaurant.

No Labels

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hispanics ages 18 through 65 years.

You may not qualify if:

  • Not being able to read and write in either English or Spanish; pregnant or lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meena Shah

Fort Worth, Texas, 76129, United States

Location

Related Publications (4)

  • Long MW, Tobias DK, Cradock AL, Batchelder H, Gortmaker SL. Systematic review and meta-analysis of the impact of restaurant menu calorie labeling. Am J Public Health. 2015 May;105(5):e11-24. doi: 10.2105/AJPH.2015.302570. Epub 2015 Mar 19.

    PMID: 25790388BACKGROUND

  • Swartz JJ, Braxton D, Viera AJ. Calorie menu labeling on quick-service restaurant menus: an updated systematic review of the literature. Int J Behav Nutr Phys Act. 2011 Dec 8;8:135. doi: 10.1186/1479-5868-8-135.

    PMID: 22152038RESULT

  • Sinclair SE, Cooper M, Mansfield ED. The influence of menu labeling on calories selected or consumed: a systematic review and meta-analysis. J Acad Nutr Diet. 2014 Sep;114(9):1375-1388.e15. doi: 10.1016/j.jand.2014.05.014. Epub 2014 Jul 16.

    PMID: 25037558RESULT

  • Shah M, Bouza B, Adams-Huet B, Jaffery M, Esposito P, Dart L. Effect of calorie or exercise labels on menus on calories and macronutrients ordered and calories from specific foods in Hispanic participants: a randomized study. J Investig Med. 2016 Dec;64(8):1261-1268. doi: 10.1136/jim-2016-000227. Epub 2016 Jul 8.

    PMID: 27402619DERIVED

MeSH Terms

Conditions

Food Preferences

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Meena Shah, Ph.D.

    Tzu Chi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 14, 2016

First Posted

June 17, 2016

Study Start

November 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

June 17, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)