NCT05079477

Brief Summary

The aim of this study is to determine the degree to which sugar-sweetened beverages (SSB) warning labels increase consumers' knowledge about the potential health harms of SSBs and reduce SSB purchases and consumption. 216 racially and ethnically diverse parents of children 6-11 years old will be recruited to buy snacks and beverages for four weeks via an online store that ships participants their purchases. Participants will be randomized to either 1) calorie labels (control); or 2) sugar graphic warning labels. The investigators hypothesize that sugar graphic warning labels displayed in an online store in weeks 2-4 will lead to the greatest reductions from week 1 across both primary outcomes compared to the control group that will only see calorie labels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2021

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

September 15, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

October 6, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 15, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2023

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

April 4, 2024

Completed
Last Updated

April 4, 2024

Status Verified

March 1, 2024

Enrollment Period

1.3 years

First QC Date

September 15, 2021

Results QC Date

January 18, 2024

Last Update Submit

March 6, 2024

Conditions

Keywords

food labelingchildsugar-sweetened beverageseatingdrinkingchoice behavior

Outcome Measures

Primary Outcomes (4)

  • Beverage Calories Purchased, Week 1

    Logged beverage calories/100mL purchased. Number of servings per item and number of items per package varied by product; therefore, calorie amounts were standardized to calories/100mL for beverages.

    one week

  • Beverage Calories Purchased, Weeks 2-4

    Logged average beverage calories/100mL purchased per week over Weeks 2-4. Number of servings per item and number of items per package varied by product; therefore, calorie amounts were standardized to calories/100mL for beverages.

    three weeks

  • Beverage Added Sugars Purchased, Week 1

    Beverage grams of added sugars/100mL purchased. Number of servings per item and number of items per package varied by product; therefore, added sugar amounts were standardized to grams of added sugar/100mL for beverages.

    one week

  • Beverage Added Sugars Purchased, Weeks 2-4

    Average beverage grams of added sugars/100mL purchased per week over Weeks 2-4. Number of servings per item and number of items per package varied by product; therefore, added sugar amounts were standardized to grams of added sugar/100mL for beverages.

    three weeks

Secondary Outcomes (40)

  • Number Purchasing a Sweetened Beverage, Week 1

    one week

  • Number Purchasing a Sweetened Beverage, Weeks 2-4

    three weeks

  • Snack Calories Purchased, Week 1

    one week

  • Snack Calories Purchased, Weeks 2-4

    three weeks

  • Snack Added Sugars Purchased, Week 1

    one week

  • +35 more secondary outcomes

Study Arms (2)

Calorie label

ACTIVE COMPARATOR

Calorie label (control) will display a calories per package label on all beverages, not just sugary drinks. This is modeled after the American Beverage Association's current "Clear on Calories" labels. Additionally, all snack items will have a calories per serving label.

Behavioral: Exposure to calorie information

Sugar graphic warning label

EXPERIMENTAL

All products in this arm will also have calorie labels. Beverages with added sugar will also have sugar graphic warning labels with the text: "WARNING: drinking beverages with added sugars contributes to obesity, diabetes, and tooth decay" along with graphics depicting the amount of sugar in the beverage.

Behavioral: Exposure to sugar-sweetened beverage warning labelsBehavioral: Exposure to calorie information

Interventions

Graphic images of the amount of sugar (randomly assigned teaspoons, packets, or cubes) and text warning labels

Sugar graphic warning label

Calories for all beverages and foods

Calorie labelSugar graphic warning label

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
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;
  • can read and speak English;
  • primary grocery shopper for their household;
  • have regular Internet access; and
  • report that the oldest of their children between 6 and 11 years old is consuming sugar sweetened beverages at least twelve times per month or approximately three times a week

You may not qualify if:

  • not a primary caregiver of a child 6-to-11 years old;
  • \<18 years old;
  • cannot read and/or speak English;
  • not the primary grocery shopper for their household;
  • does not have regular Internet access; and
  • does not report that the oldest of their children between 6 and 11 years old is consuming sugar sweetened beverages at least twelve times per month or approximately three times a week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Food Preferences

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Results Point of Contact

Title
Dr. Laura Gibson
Organization
University of Pennsylvania

Study Officials

  • Christina A Roberto, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This randomized, controlled online study will capture beverage and snack purchases from an online store. These products will be mailed to participants for each of the 4 shopping weeks. Participants' consumption will be measured at the beginning and end of the study. As this is a within-participant study, consumption for each arm will be compared to baseline for that participant (Week 1 shopping).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2021

First Posted

October 15, 2021

Study Start

October 6, 2021

Primary Completion

January 17, 2023

Study Completion

January 17, 2023

Last Updated

April 4, 2024

Results First Posted

April 4, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

In the consenting process, participants agreed that de-identified data produced from this project may be distributed for future research studies without additional informed consent. Any de-identified data shared will be done so via PennBox, a secure method to transfer files.

Shared Documents
SAP
Time Frame
starting 6 months after publication
Access Criteria
The PI will review requests to use de-identified study data.

Locations