ObesityNCT04971317
The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages
A study testing Sugar-Sweetened Beverage (SSB) Video and Water Video in people with Obesity and Type 2 Diabetes, run by NYU Langone Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Type 2 Diabetes, Dental Caries
- What is being tested?
- Sugar-Sweetened Beverage (SSB) Video and Water Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2018to 30 Dec 2018
- 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 12 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Any participant that is not 12 years old or does not speak English will be excluded from participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages"
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.
- Conditions
- Obesity, Type 2 Diabetes, Dental Caries
- Being tested
- Sugar-Sweetened Beverage (SSB) Video, Water Video, Control
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugar-Sweetened Beverage (SSB) VideoBehavioural
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.
Water VideoBehavioural
Participants will watch a video showing an egg maintaining its shell in water, followed by the evaporation of water.
ControlBehavioural
Participants will watch a video of an egg maintaining its shell in rubbing alcohol, followed by the evaporation of rubbing alcohol.
| Study group | Role | What they receive |
|---|---|---|
| Sugar-Sweetened Beverage (SSB) Video | Experimental | Not described Receives: Behavioral: Sugar-Sweetened Beverage (SSB) Video |
| Water Video | Experimental | Not described Receives: Behavioral: Water Video |
| Control | Active comparator | Not described Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start5 Sep 2018
- Primary completion5 Dec 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie A Bragg, MD, Principal investigator, NYU Langone
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971317
- Sponsor's protocol ID
- 21-00048
- Status last verified
- Jul 2021
- First submitted
- 14 Jul 2021
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages"
- ClinicalTrials.gov ID
- NCT04971317
- Acronym / sponsor ID
- 21-00048
- Conditions
- Obesity, Type 2 Diabetes, Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 5 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 21 Jul 2021 (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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sugar-Sweetened Beverage (SSB) Video | Experimental | Behavioral: Sugar-Sweetened Beverage (SSB) Video |
| Water Video | Experimental | Behavioral: Water Video |
| Control | Active comparator | Behavioral: Control |
Who may qualify
- Ages
- 12 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Any participant that is not 12 years old or does not speak English will be excluded from participation.
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 (SSB) VideoParticipants 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. | Behavioural | Sugar-Sweetened Beverage (SSB) Video |
| Water VideoParticipants will watch a video showing an egg maintaining its shell in water, followed by the evaporation of water. | Behavioural | Water Video |
| ControlParticipants will watch a video of an egg maintaining its shell in rubbing alcohol, followed by the evaporation of rubbing alcohol. | Behavioural | Control |
Primary outcome
Frequency of SSB Consumption
Time frame: 30 days
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
Attitudes towards SSBs
Time frame: 30 days
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.
Health Perceptions of SSBs
Time frame: 30 days
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.
Plans for Future SSB Consumption Post-Intervention or Post-Control
Time frame: 30 days
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.
Attitudes towards SSBs Post-Intervention or Post-Control
Time frame: 30 days
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.
Health Perceptions of SSBs Post-Intervention or Post-Control
Time frame: 30 days
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.
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 21 Jul 2021.
- Individual participant dataSharing planned: Yes. 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.
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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.
Marie A Bragg, MD principal investigator
NYU Langone
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 (SSB) Video and Water Video in people with Obesity and Type 2 Diabetes, run by NYU Langone Health 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 1 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 21 Jul 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 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?
Frequency of SSB Consumption (time frame: 30 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2021.