NCT04435145

Brief Summary

Sugar-sweetened beverages (SSBs) are one of the few dietary items causally linked to the development of obesity and chronic disease. SSB consumption among young adults are particularly concerning, because of the high levels of consumption and the influence of disease risk in later life. College students, particularly freshmen, are a captive audience when it comes to dietary consumption because many of them consume their meals in residential dining halls. We are currently working with Michigan Dining to implement warning labels on SSB fountain dispensers to examine whether carefully tailored signage could alter beverage choices of college students. The current study aims to assess changes in dietary intake before and after the labels are posted, in a representative sample of University of Michigan students who eat at residential dining halls.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,067

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

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 6, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2020

Completed
Last Updated

June 17, 2020

Status Verified

June 1, 2020

Enrollment Period

5 months

First QC Date

June 15, 2020

Last Update Submit

June 15, 2020

Conditions

Diet, Healthy

Outcome Measures

Primary Outcomes (1)

  • Beverage Intake Questionnaire-15

    The primary outcome is the mean servings of sugar-sweetened and non-sugar-sweetened beverages consumed in the past 30 days, as measured by a validated questionnaire

    Four months

Study Arms (2)

Intervention

EXPERIMENTAL

Sugar-sweetened beverage warning label

Behavioral: Sugar-sweetened beverage warning label

Control

NO INTERVENTION

No label

Interventions

Sugar-sweetened beverage warning labelBEHAVIORAL

A sugar-sweetened beverage warning label appropriate for the college-aged population was developed and applied to beverage stations at one large campus dining hall

Intervention

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Currently enrolled student at the University
  • Visited one of three large dining halls at least 100 times in the first 1.5 months of the academic year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • Leung CW, Wolfson JA, Hsu R, Soster K, Mangan S, Falbe J. Warning Labels Reduce Sugar-Sweetened Beverage Intake among College Students. J Nutr. 2021 Jan 4;151(1):179-185. doi: 10.1093/jn/nxaa305.

    PMID: 33245125DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 15, 2020

First Posted

June 17, 2020

Study Start

November 6, 2018

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

June 17, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)