NCT04971317

Brief Summary

Sugar-sweetened beverage (SSB) consumption is associated with the development of obesity, type 2 diabetes, and dental caries. The current study attempts to explore whether an educational, science-based intervention is able to produce a measurable negative change in preferences for sugar-sweetened beverages, as well as initiate plans to reduce future SSB consumption in 12-year old children. In the first condition (SSB Intervention), participants will watch a video showing the decay of an egg in various SSBs (Coca-Cola, Sprite, Gatorade, and apple juice), followed by the evaporation of these beverages over a heat source, revealing their sugar content. In the second condition (Water Intervention), participants will watch a video showing an egg maintaining its shell in water, followed by the evaporation of water. In the third condition (Control), participants will watch a video of an egg maintaining its shell in rubbing alcohol, followed by the evaporation of rubbing alcohol. Before and after watching their assigned video, participants will complete survey questions to assess self-reported: SSB consumption intentions, attitudes toward SSBs, and health perceptions of SSBs. Therefore, the aims of this study are to (1) quantify changes in SSB consumption intentions, attitudes towards SSBs, and health perceptions of SSBs from pre-video to post-video, (2) establish the effectiveness of the SSB Intervention and Water Intervention over the control, (3) establish the effectiveness of the SSB Intervention over the Water Intervention, (4) determine the efficacy of incorporating scientific evidence in a public health intervention, and (5) make recommendations for the future application of the method employed in this intervention to future public health campaigns.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
326

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable obesity

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

September 5, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2018

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 21, 2021

Completed
Last Updated

July 21, 2021

Status Verified

July 1, 2021

Enrollment Period

3 months

First QC Date

July 14, 2021

Last Update Submit

July 14, 2021

Conditions

Outcome Measures

Primary Outcomes (6)

  • Frequency of SSB Consumption

    Measurement of how often participants consume various SSBs using the following questions: 1) During the past 30 days, how often did you drink regular soda or pop that contains sugar (such as Coca-Cola, Pepsi, Sprite, Mountain Dew, 7Up, Dr. Pepper, Ginger Ale, Fanta, etc.)? Do not include diet soda or diet pop. 2) During the past 30 days, how often did you drink sports drinks (such as Gatorade, Powerade, Vitamin Water, etc.)? Do not include diet drinks or artificially sweetened drinks. 3) During the past 30 days, how often did you drink sugar-sweetened fruit drinks (such as Kool-aid, lemonade, cranberry juice, etc.)? Do not include 100% fruit juice. \*Questions have been adapted from the BRFSS Sugar Sweetened Beverage Optional Module

    30 days

  • Attitudes towards SSBs

    Attitudes to SSBs will be assessed using the following questions measured on a 7-point likert scale: 1) I feel positive toward soda or pop/I feel negative toward soda or pop (such as Coca-Cola, Pepsi, Sprite, Mountain Dew, 7Up, Dr. Pepper, Ginger Ale, Fanta, etc.). Do not include diet soda or diet pop. 2) I feel positive toward sports drinks/I feel negative toward sports drinks (such as Gatorade, Powerade, Vitamin Water, etc.)? Do not include diet drinks or artificially sweetened drinks. 3) I feel positive toward sugar-sweetened fruit drinks/I feel negative toward sugar-sweetened fruit drinks (such as Kool-aid, lemonade, cranberry juice, etc.). Do not include 100% fruit juice.

    30 days

  • Health Perceptions of SSBs

    Response to SSBs will be assessed using the following questions measured on a 7-point likert scale: 1) I think that soda or pop (such as Coca-Cola, Pepsi, Sprite, Mountain Dew, 7Up, Dr. Pepper, Ginger Ale, Fanta, etc.) is healthy/unhealthy. Do not include diet soda or diet pop. 2) I think that sports drinks (such as Gatorade, Powerade, Vitamin Water, etc.) are healthy/unhealthy. Do not include diet drinks or artificially sweetened drinks. 3) I think that fruit drinks (such as Kool-aid, lemonade, cranberry juice, etc.) are healthy/unhealthy. Do not include 100% fruit juice.

    30 days

  • Plans for Future SSB Consumption Post-Intervention or Post-Control

    Measurement of how often participants plan to consume various SSBs using the following questions: 1) During the next 30 days, how often do you plan on drinking regular soda or pop that contains sugar (such as Coca-Cola, Pepsi, Sprite, Mountain Dew, 7Up, Dr. Pepper, Ginger Ale, Fanta, etc.)? Do not include diet soda or diet pop. 2) During the next 30 days, how often do you plan on drinking sports drinks (such as Gatorade, Powerade, Vitamin Water, etc.)? Do not include diet drinks or artificially sweetened drinks. 3) During the next 30 days, how often do you plan on drinking sugar-sweetened fruit drinks (such as Kool-aid, lemonade, cranberry juice, etc.)? Do not include 100% fruit juice.

    30 days

  • Attitudes towards SSBs Post-Intervention or Post-Control

    Response to SSBs will be assessed using the following questions measured on a 7-point likert scale: 1) I feel positive toward soda or pop/I feel negative toward soda or pop (such as Coca-Cola, Pepsi, Sprite, Mountain Dew, 7Up, Dr. Pepper, Ginger Ale, Fanta, etc.). Do not include diet soda or diet pop. 2) I feel positive toward sports drinks/I feel negative toward sports drinks (such as Gatorade, Powerade, Vitamin Water, etc.)? Do not include diet drinks or artificially sweetened drinks. 3) I feel positive toward sugar-sweetened fruit drinks/I feel negative toward sugar-sweetened fruit drinks (such as Kool-aid, lemonade, cranberry juice, etc.). Do not include 100% fruit juice.

    30 days

  • Health Perceptions of SSBs Post-Intervention or Post-Control

    Response to SSBs will be assessed using the following questions measured on a 7-point likert scale: 1) I think that soda or pop (such as Coca-Cola, Pepsi, Sprite, Mountain Dew, 7Up, Dr. Pepper, Ginger Ale, Fanta, etc.) is healthy/unhealthy. Do not include diet soda or diet pop. 2) I think that sports drinks (such as Gatorade, Powerade, Vitamin Water, etc.) are healthy/unhealthy. Do not include diet drinks or artificially sweetened drinks. 3) I think that fruit drinks (such as Kool-aid, lemonade, cranberry juice, etc.) are healthy/unhealthy. Do not include 100% fruit juice.

    30 days

Study Arms (3)

Sugar-Sweetened Beverage (SSB) Video

EXPERIMENTAL
Behavioral: Sugar-Sweetened Beverage (SSB) Video

Water Video

EXPERIMENTAL
Behavioral: Water Video

Control

ACTIVE COMPARATOR
Behavioral: Control

Interventions

Participants will watch a video showing the decay of an egg in various SSBs (Coca-Cola, Sprite, Gatorade, and apple juice), followed by the evaporation of these beverages over a heat source, revealing their sugar content.

Sugar-Sweetened Beverage (SSB) Video
Water VideoBEHAVIORAL

Participants will watch a video showing an egg maintaining its shell in water, followed by the evaporation of water.

Water Video
ControlBEHAVIORAL

Participants will watch a video of an egg maintaining its shell in rubbing alcohol, followed by the evaporation of rubbing alcohol.

Control

Eligibility Criteria

Age12 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • We will recruit a nationally representative sample of participants through the subdivision of Qualtrics, Qualtrics Panel. Participants must be 12 years old and English speaking.

You may not qualify if:

  • Any participant that is not 12 years old or does not speak English will be excluded from participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2Dental Caries

Interventions

Sugar-Sweetened BeveragesSSB protein, humanVideotape Recording

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesTooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesTape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Study Officials

  • Marie A Bragg, MD

    NYU Langone

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2021

First Posted

July 21, 2021

Study Start

September 5, 2018

Primary Completion

December 5, 2018

Study Completion

December 30, 2018

Last Updated

July 21, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share

The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to the PI. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Shared Documents
STUDY PROTOCOL, SAP

Locations