Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Facts-Up-Front Versus Traffic-Light Food Labels

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01626729
Recruitment Status : Completed
First Posted : June 25, 2012
Last Update Posted : June 25, 2012
Sponsor:
Collaborator:
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
Christina Roberto, Yale University

Tracking Information
First Submitted Date  ICMJE June 14, 2012
First Posted Date  ICMJE June 25, 2012
Last Update Posted Date June 25, 2012
Study Start Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2012)
  • Nutrient Comparison and Nutrient Level Estimation Accuracy [ Time Frame: Baseline ]
    Participants took a nutrient level comparison quiz asking them to identify which of two products presented side-by-side in the same food category were higher or lower in different nutrients. Participants also viewed 8 individual products and estimated whether the product had low, medium or high amounts of saturated fat, sugar, sodium, fiber, and protein. The primary outcomes were total percentage correct on these quizzes.
  • Perceptions of Health, Taste and Purchase Intent [ Time Frame: Baseline ]
    Participants rated how healthy they thought each individual product was, how good it would taste and their likelihood to buy the product for themselves and their children (answered only by those who reported having children) using a 9-point Likert scale. Each set of ratings was averaged across eight products.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2012)
Consumer Label Preferences [ Time Frame: Baseline ]
Composite scores were created based on several items assessing ease of label interpretation and understanding, label complexity, and degree of label confusion.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Facts-Up-Front Versus Traffic-Light Food Labels
Official Title  ICMJE Facts-Up-Front Versus Traffic-Light Food Labels: A Randomized Controlled Trial
Brief Summary The U.S. food and beverage industry recently released a new front-of-package nutrition labeling system called Facts Up Front that will be used on thousands of food products. The purpose of this study was to test consumer understanding of the Facts Up Front nutrition labeling system compared to the Multiple Traffic Light system (Traffic Light). Facts Up Front displays grams/milligrams and % daily value information for various nutrients; Traffic Light uses an interpretive color-coded scheme to alert consumers to low, medium or high levels of certain nutrients. Participants in an Internet-based study were randomized to one of five front-of-package label conditions: 1) No Label; 2) Traffic Light; 3) Traffic Light plus information about protein and fiber (Traffic Light+); 4) Facts Up Front; or 5) Facts Up Front plus information about "nutrients to encourage" (Facts Up Front+). Total percentage correct quiz scores were generated reflecting participants' ability to compare two foods on nutrient levels, based on their labels, and to estimate amounts of saturated fat, sugar, sodium, fiber and protein in foods. 703 adult participants recruited through an online database in May 2011 participated in this Internet-based study and data were analyzed in June 2011. The investigators hypothesized that the Traffic Light label groups would perform better than the Facts Up Front groups on all outcomes.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Food Labeling
Intervention  ICMJE
  • Behavioral: Traffic Light
    A kilocalories (calories) per serving label and a Traffic Light symbol with High/Med/Low text indicating amounts of saturated fat, total sugars, and sodium per serving.
  • Behavioral: Traffic Light+
    A calories per serving label and a Traffic Light symbol with High/Med/Low text indicating amounts of saturated fat, total sugars, sodium, fiber and protein per serving.
  • Behavioral: Facts Up Front
    A label displaying calories, saturated fat, sodium, and total sugars per serving. Nutrient amounts were listed in grams/milligrams and % Daily Values (%DVs), which indicate whether a serving of food is high or low in a nutrient based on daily value recommendations for a 2,000 calorie diet, were included. This symbol was created based on the Facts Up Front symbol description provided by the Grocery Manufacturers Association and Food Marketing Institute, without the inclusion of nutrients to encourage.
  • Behavioral: Facts Up Front+
    A label displaying calories, saturated fat, sodium, and total sugars per serving. The label also showed two (out of the possible eight) nutrients to encourage with the highest %DV. Nutrient amounts were listed in grams/milligrams and %DVs were included. This symbol was based directly on the Facts Up Front symbol description provided by the Grocery Manufacturers Association and Food Marketing Institute.
  • Behavioral: No label control group
    No label control group
Study Arms  ICMJE
  • Experimental: Traffic Light
    Intervention: Behavioral: Traffic Light
  • Experimental: Traffic Light+
    Intervention: Behavioral: Traffic Light+
  • Experimental: Facts Up Front
    Intervention: Behavioral: Facts Up Front
  • Experimental: Facts Up Front+
    Intervention: Behavioral: Facts Up Front+
  • Placebo Comparator: No front of package label
    Intervention: Behavioral: No label control group
Publications * Roberto CA, Bragg MA, Schwartz MB, Seamans MJ, Musicus A, Novak N, Brownell KD. Facts up front versus traffic light food labels: a randomized controlled trial. Am J Prev Med. 2012 Aug;43(2):134-41. doi: 10.1016/j.amepre.2012.04.022.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 20, 2012)
703
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants in Survey Sampling International Panels

Exclusion Criteria:

  • Younger than 18 years old
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01626729
Other Study ID Numbers  ICMJE 1101007870
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christina Roberto, Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE Robert Wood Johnson Foundation
Investigators  ICMJE
Principal Investigator: Christina A Roberto, PhD Yale University
PRS Account Yale University
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP