Food PreferencesPhase 3NCT04022694

Preventing Non-communicable Diseases in Guatemala Through Sugary Drink Reduction

A Phase 3 study testing Exposure to beverage health information and Exposure to beverage calorie information in people with Food Preferences, run by University of Pennsylvania at 1 site in Guatemala.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 12 to 18 yearsHealthy volunteers can take part
Conditions the study is for: Food Preferences
What is being tested?: Exposure to beverage health information and Exposure to beverage calorie information
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 628 participants
Where: 1 siteGuatemala
Study dates: 8 Jul 2019to 30 Aug 2019
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 12 to 18 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Between 12 and 18 years old
Made a food or beverage purchase
Has permission from parent or caregiver to participate
Has not yet completed the purchase assessment

Who cannot join

Under 12 or over 18 years old
Did not make a food or beverage purchase
Parent or caregiver refused to give child permission to participate
Already participated in the purchase assessment

Trial locations and contacts

1 site in 1 country.

Guatemala1 site

Universidad Rafael Landivar
Guatemala City

Other trials in Guatemala

About this study

Sugar-sweetened beverages are a significant contributor to adult and childhood obesity in Guatemala. Policies to place health warning labels on sugar-sweetened beverages are being pursued, but there is little empirical data on how such labels influence people. The primary aim of this study is to test the association between sugar-sweetened beverage (SSB) warning posters compared to control posters and change in SSBs purchased compared to baseline by adolescents shopping at school cafeterias in Guatemala City, Guatemala. The hypothesis is that posters with information warning people of the health harms associated with overconsuming SSBs and promoting low sugar beverages will be associated with greater reductions in SSB purchases compared to a control poster.

Conditions: Food Preferences
Being tested: Exposure to beverage health information, Exposure to beverage calorie information
Keywords: Food Labeling, Adolescents
Medical subject headings: Food Preferences

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Exposure to beverage health informationBehavioural
Red stop sign and avoidance message for sugar-sweetened beverages and green check mark and promotion message for non-sugar-sweetened beverage nutrition information
Exposure to beverage calorie informationBehavioural
Calories for sugar-sweetened and non-sugar-sweetened beverages

Study groups in NCT04022694
Study group	Role	What they receive
Calorie/Control Poster	Active comparator	This poster will display images of both SSBs and low or no sugar beverages with calories listed below the beverages. It will simply state that those beverages are sold in the school store. Receives: Behavioral: Exposure to beverage calorie information
SSB Warning and Non-SSB Promotion Poster	Experimental	This poster will display images of both SSBs and low or no sugar beverages with calories listed below the beverages. In addition, the message will state that SSBs are high in sugar and should be avoided, while low or no sugar beverages are healthier options and should be chosen. Receives: Behavioral: Exposure to beverage health information; Behavioral: Exposure to beverage calorie information
Baseline for Calorie/Control Poster	No intervention	We will collect baseline data from a group of students before posting the Calorie/Control Poster in the control school.
Baseline for SSB Warning and Non-SSB Promotion Poster	No intervention	We will collect baseline data from a group of students before posting the SSB Warning and Non-SSB Promotion Poster in the intervention school.

What is being measured

The primary outcome is the main question the study is designed to answer.

Volume of SSBs Per Transaction
Total milliliters of SSBs per transaction from sales data
Measured: Through study period (either 4 weeks baseline, or 4 weeks intervention)
Beverage Calories Per Transaction
Total number of calories for all beverages (SSBs and non-SSBs) per transaction from sales data
Measured: Through study period (either 4 weeks baseline or 4 weeks intervention)

Secondary outcomes (1)

Total Calories Per Transaction
Total number of calories for all food and beverages (SSBs and non-SSBs) per transaction from purchase assessments (e.g., calories from Coke + bag of chips)
Measured: Through time frame (either 4 weeks baseline, or 4 weeks intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jul 201930 Aug 2019

First posted17 Jul 2019
Study start8 Jul 2019
Primary completion30 Aug 2019
Study completion30 Aug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Food PreferencesStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe 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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Three private schools will be enrolled in the study (two larger, one smaller) that have students between the ages of 12 and 18. There will be no posters displayed at any of the schools during the baseline period. The two larger schools will be randomized to either an SSB warning/non-SSB promoting poster or a calorie/control poster that will be implemented in the school cafeterias during a four-week intervention period. To increase the sample size for the intervention condition, the intervention will also be implemented at a smaller school. For the primary analysis, data only from schools that were randomized to condition will be used. Data was collected from both a sample of participants \& from the cash registers directly.
Masking: None (open label)
Enrolment: 628 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04022694
Sponsor's protocol ID: R21TW010837
Other IDs: R21TW010837
Status last verified: Mar 2021
First submitted: 9 Jul 2019
Last updated: 25 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Food Preferences trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Preventing Non-communicable Diseases in Guatemala Through Sugary Drink Reduction
ClinicalTrials.gov ID: NCT04022694
Acronym / sponsor ID: R21TW010837
Conditions: Food Preferences
Keywords: Food Labeling, Adolescents
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 628 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: Fogarty International Center of the National Institute of Health, Universidad Rafael Landivar
Study start: 8 Jul 2019 (actual)
Primary completion: 30 Aug 2019 (actual)
Study completion: 30 Aug 2019 (actual)
First posted: 17 Jul 2019 (actual)
Results: Posted 25 Mar 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4
Model description: Three private schools will be enrolled in the study (two larger, one smaller) that have students between the ages of 12 and 18. There will be no posters displayed at any of the schools during the baseline period. The two larger schools will be randomized to either an SSB warning/non-SSB promoting poster or a calorie/control poster that will be implemented in the school cafeterias during a four-week intervention period. To increase the sample size for the intervention condition, the intervention will also be implemented at a smaller school. For the primary analysis, data only from schools that were randomized to condition will be used. Data was collected from both a sample of participants \& from the cash registers directly.

Arm	Type	Receives
Calorie/Control Poster	Active comparator	Behavioral: Exposure to beverage calorie informationThis poster will display images of both SSBs and low or no sugar beverages with calories listed below the beverages. It will simply state that those beverages are sold in the school store.
SSB Warning and Non-SSB Promotion Poster	Experimental	Behavioral: Exposure to beverage health information, Behavioral: Exposure to beverage calorie informationThis poster will display images of both SSBs and low or no sugar beverages with calories listed below the beverages. In addition, the message will state that SSBs are high in sugar and should be avoided, while low or no sugar beverages are healthier options and should be chosen.
Baseline for Calorie/Control Poster	No intervention	–We will collect baseline data from a group of students before posting the Calorie/Control Poster in the control school.
Baseline for SSB Warning and Non-SSB Promotion Poster	No intervention	–We will collect baseline data from a group of students before posting the SSB Warning and Non-SSB Promotion Poster in the intervention school.

Who may qualify

Ages: 12 to 18 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

Between 12 and 18 years old
Made a food or beverage purchase
Has permission from parent or caregiver to participate
Has not yet completed the purchase assessment

Key exclusion criteria (4 listed)

Under 12 or over 18 years old
Did not make a food or beverage purchase
Parent or caregiver refused to give child permission to participate
Already participated in the purchase assessment

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
Exposure to beverage health informationRed stop sign and avoidance message for sugar-sweetened beverages and green check mark and promotion message for non-sugar-sweetened beverage nutrition information	Behavioural	SSB Warning and Non-SSB Promotion Poster
Exposure to beverage calorie informationCalories for sugar-sweetened and non-sugar-sweetened beverages	Behavioural	Calorie/Control Poster, SSB Warning and Non-SSB Promotion Poster

Primary outcome

Volume of SSBs Per Transaction
Time frame: Through study period (either 4 weeks baseline, or 4 weeks intervention)
Total milliliters of SSBs per transaction from sales data
Beverage Calories Per Transaction
Time frame: Through study period (either 4 weeks baseline or 4 weeks intervention)
Total number of calories for all beverages (SSBs and non-SSBs) per transaction from sales data

1 secondary outcome

Total Calories Per Transaction
Time frame: Through time frame (either 4 weeks baseline, or 4 weeks intervention)

Results and safety

Results posted to the registry on 25 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Baseline for Calorie/Control Poster	167	167
Baseline for SSB Warning and Non-SSB Promotion Poster	145	145
Calorie/Control Poster	143	143
SSB Warning and Non-SSB Promotion Poster	173	173

Primary outcome: Volume of SSBs Per Transaction

Time frame: Through study period (either 4 weeks baseline, or 4 weeks intervention). Mean (Standard Deviation). Unit: mL of Sugar Sweetened Beverages purchase

Measure	Baseline for Calorie/Control Poster n = NA	Baseline for SSB Warning and Non-SSB Promotion Poster n = NA	Calorie/Control Poster n = NA	SSB Warning and Non-SSB Promotion Poster n = NA
Value	116.2 (212.5)	89.8 (160.1)	115.3 (211.8)	103.4 (176.2)

Population analysed: In addition to the surveys with the participants (described in the participant flow), data on total sales were collected at the register. It is not possible to know if these sales data were associated with one or more than one participant because they are at the sales item level. For the purposes of this report, the number of participants are identical to the number of items sold.

Primary outcome: Beverage Calories Per Transaction

Time frame: Through study period (either 4 weeks baseline or 4 weeks intervention). Mean (Standard Deviation). Unit: beverage calories sold

Measure	Baseline for Calorie/Control Poster n = NA	Baseline for SSB Warning and Non-SSB Promotion Poster n = NA	Calorie/Control Poster n = NA	SSB Warning and Non-SSB Promotion Poster n = NA
Value	45.1 (83.7)	35.9 (67.1)	41.2 (75.9)	39.0 (69.0)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 8 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Baseline for Calorie/Control Poster	0 of 167 (0%)	0 of 167 (0%)	0 of 167
Baseline for SSB Warning and Non-SSB Promotion Poster	0 of 145 (0%)	0 of 145 (0%)	0 of 145
Calorie/Control Poster	0 of 143 (0%)	0 of 143 (0%)	0 of 143
SSB Warning and Non-SSB Promotion Poster	0 of 173 (0%)	0 of 173 (0%)	0 of 173

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Recruiting
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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.

Christina A Roberto, PhD principal investigator

University of Pennsylvania

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Exposure to beverage health information and Exposure to beverage calorie information in people with Food Preferences, run by University of Pennsylvania at 1 site in Guatemala.

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 4 inclusion and 4 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 25 Mar 2021. 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 Guatemala. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Volume of SSBs Per Transaction (time frame: Through study period (either 4 weeks baseline, or 4 weeks intervention)). The study lists 2 primary outcomes in all. 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 NCT04022694.

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 25 Mar 2021.