NCT03648138

Brief Summary

The aim of this study is to compare different sugary drink labels to see which most influence knowledge, beliefs, purchase intentions and choices. Parents of children ages 6-11 will shop in a virtual convenience store after being randomized to 1 of 4 conditions: 1) calorie labels; 2) text warning labels; 3) graphic sugar warning labels; or 4) graphic health warning. This study will provide data comparing the influence of sugary drink text warning labels and two kinds of graphic warning labels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,016

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jan 2020

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

First Submitted

Initial submission to the registry

August 7, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 27, 2018

Completed
1.4 years until next milestone

Study Start

First participant enrolled

January 17, 2020

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2020

Completed
Last Updated

March 11, 2020

Status Verified

March 1, 2020

Enrollment Period

11 days

First QC Date

August 7, 2018

Last Update Submit

March 10, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hypothetical beverage choice

    Participants will select a beverage to purchase in the virtual store. Our outcome will be the percentage of parents choosing a 20-ounce sugary drink for their child

    The survey will take up to 20 minutes

Secondary Outcomes (13)

  • Likely to serve or buy these beverages:

    The survey will take up to 20 minutes

  • Parent feels good serving the beverages

    The survey will take up to 20 minutes

  • Child enjoyment of beverages

    The survey will take up to 20 minutes

  • Health beliefs and risk perceptions index

    The survey will take up to 20 minutes

  • Estimate of how many teaspoons of added sugar are in the beverages

    The survey will take up to 20 minutes

  • +8 more secondary outcomes

Study Arms (4)

Calorie label

ACTIVE COMPARATOR

This arm will display a "Calories per Bottle" label on all beverages, not just sugary beverages. This label is identical to the American Beverage Association's current "Clear on Calories" labels (as of 2018).

Behavioral: Sugary drink warning labels

Text warning label

EXPERIMENTAL

This arm will display similar text proposed in a recent sugary drink warning label bill in California. Sample text: WARNING: Drinking beverages with added sugar(s) contributes to obesity, type 2 diabetes, and tooth decay. The calorie label will also appear on all beverages.

Behavioral: Sugary drink warning labels

Sugar graphic warning label

EXPERIMENTAL

This arm will graphically display the amount of sugar in each sugary beverage along with the same text used in the "text warning label" arm. The calorie label will also appear on all beverages.

Behavioral: Sugary drink warning labels

Health graphic warning label

EXPERIMENTAL

This arm will graphically display potential negative health effects of over consuming sugary drinks for each sugary beverage, along with the same text used in the "text warning label" arm. The calorie label will also appear on all beverages.

Behavioral: Sugary drink warning labels

Interventions

This information appears in the description of the study arms.

Calorie labelHealth graphic warning labelSugar graphic warning labelText warning label

Eligibility Criteria

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

You may qualify if:

  • a primary caregiver of a child 6-to-11 years old;
  • ≥18 years old; and
  • can read and speak English

You may not qualify if:

  • not a primary caregiver of a child 6-to-11 years old;
  • \<18 years old; and
  • cannot read and/or speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Online study with GfK

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Musicus AA, Gibson LA, Bellamy SL, Orr JA, Hammond D, Glanz K, Volpp KG, Schwartz MB, Bleakley A, Strasser AA, Roberto CA. Effects of Sugary Beverage Text and Pictorial Warnings: A Randomized Trial. Am J Prev Med. 2023 May;64(5):716-727. doi: 10.1016/j.amepre.2023.01.018. Epub 2023 Feb 8.

MeSH Terms

Conditions

ObesityWeight GainDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • Christina A Roberto, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Although participants are not blinded to the study arm to which they are randomized, they are not told the true purpose of the study until after completing the study.
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medical Ethics and Health Policy

Study Record Dates

First Submitted

August 7, 2018

First Posted

August 27, 2018

Study Start

January 17, 2020

Primary Completion

January 28, 2020

Study Completion

January 28, 2020

Last Updated

March 11, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

We will share a de-identified dataset via an online data storage website (e.g., open science framework, dataverse, research box)

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
The data will be made available soon after the paper is published in a peer-reviewed journal.
Access Criteria
All researchers will be able to access the data.

Locations