Reducing Sugar-sweetened Beverage Consumption Among Young Adults

January 18, 2019 updated by: University of California, Davis
This study aims to test sugar-sweetened beverage (SSB) health labeling elements in an online experiment to determine which elements are the most salient among young adults.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2971

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Davis, California, United States, 95616
        • University of California, Davis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria:

  • ≥18 years of age
  • current/recent (<1 year of graduation) undergraduate student at 3 specific universities
  • English-speaking
  • consumes at least 2 SSBs per week

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Loss-frame, text-only, no attribution
Label participants will see is loss-frame, text-only, and with no attribution
Other: loss-frame
loss frame label
Other: text-only
text-only label
Other: no attribution
label with no attribution
Experimental: Gain-frame, text-only, no attribution
Label participants will see is gain-frame, text-only, and with no attribution
Other: text-only
text-only label
Other: no attribution
label with no attribution
Other: gain-frame
gain frame label
Experimental: Loss-frame, icon, no attribution
Label participants will see is loss-frame, icon, and with no attribution
Other: loss-frame
loss frame label
Other: no attribution
label with no attribution
Other: icon
label with icon and text
Experimental: Grain-frame, icon, no attribution
Label participants will see is gain-frame, with an icon, and with no attribution
Other: no attribution
label with no attribution
Other: gain-frame
gain frame label
Other: icon
label with icon and text
Experimental: Loss-frame, icon, attribution
Label participants will see is loss-frame, icon, and with attribution
Other: loss-frame
loss frame label
Other: icon
label with icon and text
Other: attribution
label with attribution
Experimental: Gain-frame, icon, attribution
Label participants will see is grain-frame, icon, and with attribution
Other: gain-frame
gain frame label
Other: icon
label with icon and text
Other: attribution
label with attribution
Experimental: Loss-frame, text-only, attribution
Label participants will see is loss-frame, text-only, and with attribution
Other: loss-frame
loss frame label
Other: text-only
text-only label
Other: attribution
label with attribution
Experimental: Gain-frame, text-only, attribution
Label participants will see is gain-frame, text-only, and with attribution
Other: text-only
text-only label
Other: gain-frame
gain frame label
Other: attribution
label with attribution
Placebo Comparator: No label
Participant will not see a label
Other: No label
No label

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
SSB Intention
Time Frame: Up to 20 minutes
Intention to consume SSBs measured by hypothetical selection of a beverage from images of beverage options.
Up to 20 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
SSB Intention (2)
Time Frame: Up to 20 minutes
Measured by survey items assessing intention to consume SSBs on a scale from 1 (not at all likely) to 7 (extremely likely).
Up to 20 minutes
SSB attitudes
Time Frame: Up to 20 minutes
Measured by survey items assessing perceived healthfulness of SSBs on a scale from 1 (extremely unhealthy) to 7 (extremely healthy).
Up to 20 minutes
SSB knowledge
Time Frame: Up to 20 minutes
Measured by survey items assessing knowledge of number of calories (estimate provided by participant) and sugar (estimated by participant, in teaspoons) contained in SSBs.
Up to 20 minutes
SSB norms
Time Frame: Up to 20 minutes
Measured by survey item assessing how often participants perceive their peers to consume SSBs (1 = multiple times a day, 2 = daily, 3 = weekly, 4 = less than once a week, and 5 = never) and item on perception that people who are important to the participant would want them to limit SSB intake, on a scale from 1 (not at all) to 5 (completely) .
Up to 20 minutes

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
SSB self-efficacy
Time Frame: Up to 20 minutes
Measured by survey item assessing how confident participant feels in reducing SSB consumption, on a scale from 1 (not at all) to 5 (completely).
Up to 20 minutes
Social interaction
Time Frame: Up to 20 minutes
Measured by survey item assessing likelihood participant will encourage others to reduce SSB consumption, on a scale from 1 (not at all) to 5 (completely).
Up to 20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Davis

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jennifer Falbe, ScD, MPH, University of California, Davis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 18, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 17, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 17, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1124060
  • 1K01DK113068-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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