Diet, HealthyNCT04435145
Warning Labels and College Students' Sugar-Sweetened Beverage Intake
A study testing Sugar-sweetened beverage warning label in people with Diet, Healthy, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy
- What is being tested?
- Sugar-sweetened beverage warning label
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,067 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2018to 31 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Warning Labels on Reducing College Students' Sugar-Sweetened Beverage Intake
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.
- Conditions
- Diet, Healthy
- Being tested
- Sugar-sweetened beverage warning label
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugar-sweetened beverage warning labelBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Sugar-sweetened beverage warning label Receives: Behavioral: Sugar-sweetened beverage warning label |
| Control | No intervention | No label |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start6 Nov 2018
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diet, HealthyStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,067 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cindy Leung, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04435145
- Sponsor's protocol ID
- HUM00153805
- Status last verified
- Jun 2020
- First submitted
- 15 Jun 2020
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33245125
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Warning Labels on Reducing College Students' Sugar-Sweetened Beverage Intake
- ClinicalTrials.gov ID
- NCT04435145
- Acronym / sponsor ID
- HUM00153805
- Conditions
- Diet, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,067 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 6 Nov 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 17 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Sugar-sweetened beverage warning labelSugar-sweetened beverage warning label |
| Control | No intervention | –No label |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sugar-sweetened beverage warning labelA sugar-sweetened beverage warning label appropriate for the college-aged population was developed and applied to beverage stations at one large campus dining hall | Behavioural | Intervention |
Primary outcome
Beverage Intake Questionnaire-15
Time frame: Four months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Derived from this study: PubMed 33245125Leung 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.
- Individual participant dataSharing planned: No
Related trials for Diet, Healthy
Not yet recruiting
Testing a Smartphone App to Support a Mediterranean Diet and Strength Exercise
Treatment Adherence and Compliance, Resistance Exercise
Not yet recruiting
Effects of Ad Libitum Ultra-Processed Diet on Brain Dopamine in Humans
Healthy Volunteers
Recruiting
Nutrition Outcomes Using a Randomized Intervention Via Smartphone on Dietary Habits
Healthy Adult Participants, Mindful Eating Intervention
Not yet recruiting
Web-Based Sustainable Food Literacy Program for University Students
Food Literacy, Healthy Eating
Recruiting
Environmental Harm Menu Labels and Overall Dietary Quality
Food Choices
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugar-sweetened beverage warning label in people with Diet, Healthy, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beverage Intake Questionnaire-15 (time frame: Four months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04435145, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2020.