Preventing Non-communicable Diseases in Guatemala Through Sugary Drink Reduction

NCT ID: NCT04022694

Last Updated: 2021-03-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

628 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-08

Study Completion Date

2019-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Food Preferences

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Participants will be told the researchers are interested in cafeteria purchase preferences, but participants will not know which condition has been assigned to individual participants.

Study Groups

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Calorie/Control Poster

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.

Group Type ACTIVE_COMPARATOR

Exposure to beverage calorie information

Intervention Type BEHAVIORAL

Calories for sugar-sweetened and non-sugar-sweetened beverages

SSB Warning and Non-SSB Promotion Poster

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.

Group Type EXPERIMENTAL

Exposure to beverage health information

Intervention Type BEHAVIORAL

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 information

Intervention Type BEHAVIORAL

Calories for sugar-sweetened and non-sugar-sweetened beverages

Baseline for Calorie/Control Poster

We will collect baseline data from a group of students before posting the Calorie/Control Poster in the control school.

Group Type NO_INTERVENTION

No interventions assigned to this group

Baseline for SSB Warning and Non-SSB Promotion Poster

We will collect baseline data from a group of students before posting the SSB Warning and Non-SSB Promotion Poster in the intervention school.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exposure to beverage health information

Red stop sign and avoidance message for sugar-sweetened beverages and green check mark and promotion message for non-sugar-sweetened beverage nutrition information

Intervention Type BEHAVIORAL

Exposure to beverage calorie information

Calories for sugar-sweetened and non-sugar-sweetened beverages

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fogarty International Center of the National Institute of Health

NIH

Sponsor Role collaborator

Universidad Rafael Landivar

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christina A Roberto, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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Universidad Rafael Landivar

Guatemala City, , Guatemala

Site Status

Countries

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Guatemala

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

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Document Type: Informed Consent Form

View Document

Other Identifiers

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R21TW010837

Identifier Type: NIH

Identifier Source: secondary_id

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R21TW010837

Identifier Type: NIH

Identifier Source: org_study_id

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