Sodium ExcessNCT05735457
A Short, Animated Storytelling Video to Increase Knowledge About Sodium Intake as a Cardiovascular Risk Factor
A study testing A short, animated storytelling video on dietary sodium in people with Sodium Excess and Cardiovascular Risk Factor, run by University Hospital Freiburg.
Trial summary
This study will evaluate the effect of a short, animated storytelling intervention video on sodium intake as a major risk factor for cardiovascular disease on immediate and medium-term retention of knowledge about the risks of cardiovascular diesaes due to increased sodium intake. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Sodium Excess, Cardiovascular Risk Factor, Education Entertainment Intervention
- What is being tested?
- A short, animated storytelling video on dietary sodium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 31 Aug 2023
- 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 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Registration with the Prolific Academic platform
Who cannot join
- none
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Short, Animated Storytelling Video to Increase Knowledge About Sodium Intake as a Major Cardiovascular Risk Factor and to Give Recommendations for a Low-sodium Healthy Diet: an Online, Randomized, Controlled Trial
This study will evaluate the effect of a short, animated storytelling intervention video on sodium intake as a major risk factor for cardiovascular disease on immediate and medium-term retention of knowledge about the risks of cardiovascular diesaes due to increased sodium intake. We will also measure voluntary engagement with the content of the short, animated storytelling intervention video on positive psychological capital.
In this 4-armed, parallel, randomized controlled trial, 10,000 adult, US participants will be randomly assigned to (1) a short, animated storytelling intervention video on sodium as a cardiovascular disease risk factor followed by surveys assessing the facts om sodium and cardiovascular disease conveyed in the video (2) the surveys only, (3) an attention placebo control video followed by the before mentioned surveys, and (4) an arm that is exposed to neither the video nor the surveys. Two weeks later, participants in all four arms will complete all of the surveys.
The primary outcome is knowledge about the cardiovascular disease risk associated with increased sodium intake (immediate and medium-term). The major scondary outcome is the extent of voluntary engagement with the short, animated storytelling video content.
- Conditions
- Sodium Excess, Cardiovascular Risk Factor, Education Entertainment Intervention, Short, Animated Storytelling
- Being tested
- A short, animated storytelling video on dietary sodium, A short, animated storytelling attention placebo video
- Medical subject headings
- Hypernatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A short, animated storytelling video on dietary sodiumOther
Participants in the Intervention Arm will view a short, animated storytelling video on dietary sodium and the risks of cardiovascular disease due to increased intake of sodium.
A short, animated storytelling attention placebo videoOther
The Attention Placebo Control Arm will view an attention placebo control video, unrelated to the outcomes measured in this trial.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Participants will be shown a short, animated storytelling (SAS) video on dietary sodium and thereafter be asked to complete a questionnaire to assess knowledge on dietary sodium and behavioral expectation.
Two weeks later, participants will once again be asked to complete the knowledge and behavioral expectation questionnaire. Receives: Other: A short, animated storytelling video on dietary sodium |
| Exposed Control Arm | No intervention | Participants will be asked to complete a questionnaire to assess knowledge on dietary sodium and behavioral expectation (the same questionnaire as in arm 1, however, without being exposed to the SAS video on dietary sodium before. Two weeks later, participants will once again be asked to complete the knowledge and behavioral expectation questionnaire. |
| Attention Placebo Control Arm | Placebo comparator | Participants will be shown a attention placebo control (APC) video, unrelated to the outcomes measured in this trial, before being asked to complete the knowledge and behavioral expectation questionnaire.
Two weeks later, participants will once again be asked to complete the knowledge and behavioral expectation questionnaire. Receives: Other: A short, animated storytelling attention placebo video |
| Un-exposed Control Arm | No intervention | Participants will not view a video and will not be asked to complete the questionnaire. Two weeks later, participants will once again be asked to complete the knowledge and behavioral expectation questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate effect of the short, animated storytelling intervention video on knowledge about dietary sodium as a cardiovascular risk factor
The immediate effect of the short, animated storytelling intervention video on knowledge about dietary sodium as a cardiovascular risk factor assessed by a sodium questionnaire containing 30 questions.
Measured: immediately after watching the video
Medium-term effect of the short, animated storytelling intervention video on knowledge about dietary sodium as a cardiovascular risk factor
The medium-term effect of the short, animated storytelling intervention video on knowledge about dietary sodium as a cardiovascular risk factor assessed by a sodium questionnaire containing 30 questions.
Measured: 2 weeks after watching the video
Secondary outcomes (4)
Immediate effect of the short, animated storytelling intervention video on behavioral expectation to reduce dietary sodium.
The immediate effect of the short, animated storytelling intervention video on behavioral expectation to reduce dietary sodium assessed by a questionnaire containing 30 questions on behavioral expectation.
Measured: immediately after watching the video
Medium-term effect of the short, animated storytelling intervention video on behavioral expectation to reduce dietary sodium.
The medium-term effect of the short, animated storytelling intervention video on behavioral expectation to reduce dietary sodium assessed by a questionnaire containing 30 questions on behavioral expectation.
Measured: 2 weeks after watching the video
Voluntary post-trial engagement (frequency) with the video content.
Assessment of the frequency (absolute number) of watching the trial videos after completion of the trial questionnaires
Measured: 2 weeks after entering the trial
Voluntary post-trial engagement (duration) with the video content.
Assessment of the duration (in minutes) of watching the trial videos after completion of the trial questionnaires
Measured: 2 weeks after entering the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Jun 2023 (estimated)
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sodium ExcessStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, Heidelberg University
- Responsible party
- Principal investigator, PD Dr. Alexander Supady, University Hospital Freiburg
- Investigators
- Till Bärnighausen, Prof. Dr., Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735457
- Sponsor's protocol ID
- EduEntertainSodium_23
- Status last verified
- May 2023
- First submitted
- 31 Jan 2023
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adam M, Rohr JK, Greuel M, Nguyen VK, Abd El Aziz M, Uberreiter C, Coles O, Barnighausen T, Supady A. Digital storytelling boosts knowledge and behavioral expectation to reduce dietary sodium: a randomized controlled trial. NPJ Digit Med. 2026 Jan 9;9(1):21. doi: 10.1038/s41746-025-02258-x.
PubMed 41514069Supady A, Nguyen K, Aziz MAE, Uberreiter C, Barnighausen T, Adam M. A short, animated storytelling video about sodium intake as a major cardiovascular risk factor and recommendations for a healthy diet: an online, randomized, controlled trial. Trials. 2023 Jun 10;24(1):390. doi: 10.1186/s13063-023-07418-6.
PubMed 37296468
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Short, Animated Storytelling Video to Increase Knowledge About Sodium Intake as a Major Cardiovascular Risk Factor and to Give Recommendations for a Low-sodium Healthy Diet: an Online, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT05735457
- Acronym / sponsor ID
- EduEntertainSodium_23
- Conditions
- Sodium Excess, Cardiovascular Risk Factor, Education Entertainment Intervention, Short, Animated Storytelling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Collaborators
- Stanford University, Heidelberg University
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 21 Feb 2023 (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.
This study will evaluate the effect of a short, animated storytelling intervention video on sodium intake as a major risk factor for cardiovascular disease on immediate and medium-term retention of knowledge about the risks of cardiovascular diesaes due to increased sodium intake. We will also measure voluntary engagement with the content of the short, animated storytelling intervention video on positive psychological capital.
In this 4-armed, parallel, randomized controlled trial, 10,000 adult, US participants will be randomly assigned to (1) a short, animated storytelling intervention video on sodium as a cardiovascular disease risk factor followed by surveys assessing the facts om sodium and cardiovascular disease conveyed in the video (2) the surveys only, (3) an attention placebo control video followed by the before mentioned surveys, and (4) an arm that is exposed to neither the video nor the surveys. Two weeks later, participants in all four arms will complete all of the surveys.
The primary outcome is knowledge about the cardiovascular disease risk associated with increased sodium intake (immediate and medium-term). The major scondary outcome is the extent of voluntary engagement with the short, animated storytelling video content.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: A short, animated storytelling video on dietary sodiumParticipants will be shown a short, animated storytelling (SAS) video on dietary sodium and thereafter be asked to complete a questionnaire to assess knowledge on dietary sodium and behavioral expectation. Two weeks later, participants will once again be asked to complete the knowledge and behavioral expectation questionnaire. |
| Exposed Control Arm | No intervention | –Participants will be asked to complete a questionnaire to assess knowledge on dietary sodium and behavioral expectation (the same questionnaire as in arm 1, however, without being exposed to the SAS video on dietary sodium before. Two weeks later, participants will once again be asked to complete the knowledge and behavioral expectation questionnaire. |
| Attention Placebo Control Arm | Placebo comparator | Other: A short, animated storytelling attention placebo videoParticipants will be shown a attention placebo control (APC) video, unrelated to the outcomes measured in this trial, before being asked to complete the knowledge and behavioral expectation questionnaire. Two weeks later, participants will once again be asked to complete the knowledge and behavioral expectation questionnaire. |
| Un-exposed Control Arm | No intervention | –Participants will not view a video and will not be asked to complete the questionnaire. Two weeks later, participants will once again be asked to complete the knowledge and behavioral expectation questionnaire. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Registration with the Prolific Academic platform
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| A short, animated storytelling video on dietary sodiumParticipants in the Intervention Arm will view a short, animated storytelling video on dietary sodium and the risks of cardiovascular disease due to increased intake of sodium. | Other | Intervention Arm |
| A short, animated storytelling attention placebo videoThe Attention Placebo Control Arm will view an attention placebo control video, unrelated to the outcomes measured in this trial. | Other | Attention Placebo Control Arm |
Primary outcome
Immediate effect of the short, animated storytelling intervention video on knowledge about dietary sodium as a cardiovascular risk factor
Time frame: immediately after watching the video
The immediate effect of the short, animated storytelling intervention video on knowledge about dietary sodium as a cardiovascular risk factor assessed by a sodium questionnaire containing 30 questions.
Medium-term effect of the short, animated storytelling intervention video on knowledge about dietary sodium as a cardiovascular risk factor
Time frame: 2 weeks after watching the video
The medium-term effect of the short, animated storytelling intervention video on knowledge about dietary sodium as a cardiovascular risk factor assessed by a sodium questionnaire containing 30 questions.
4 secondary outcomes
Immediate effect of the short, animated storytelling intervention video on behavioral expectation to reduce dietary sodium.
Time frame: immediately after watching the video
Medium-term effect of the short, animated storytelling intervention video on behavioral expectation to reduce dietary sodium.
Time frame: 2 weeks after watching the video
Voluntary post-trial engagement (frequency) with the video content.
Time frame: 2 weeks after entering the trial
Voluntary post-trial engagement (duration) with the video content.
Time frame: 2 weeks after entering the trial
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Derived from this study: PubMed 41514069Adam M, Rohr JK, Greuel M, Nguyen VK, Abd El Aziz M, Uberreiter C, Coles O, Barnighausen T, Supady A. Digital storytelling boosts knowledge and behavioral expectation to reduce dietary sodium: a randomized controlled trial. NPJ Digit Med. 2026 Jan 9;9(1):21. doi: 10.1038/s41746-025-02258-x.
- Derived from this study: PubMed 37296468Supady A, Nguyen K, Aziz MAE, Uberreiter C, Barnighausen T, Adam M. A short, animated storytelling video about sodium intake as a major cardiovascular risk factor and recommendations for a healthy diet: an online, randomized, controlled trial. Trials. 2023 Jun 10;24(1):390. doi: 10.1186/s13063-023-07418-6.
- Individual participant dataSharing planned: No
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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.
Till Bärnighausen, Prof. Dr. principal investigator
Heidelberg University
Questions about this trial
What is this clinical trial studying?
A study testing A short, animated storytelling video on dietary sodium in people with Sodium Excess and Cardiovascular Risk Factor, run by University Hospital Freiburg.
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: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander Supady, MD, MPH (+4976127073790, alexander.supady@uniklinik-freiburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate effect of the short, animated storytelling intervention video on knowledge about dietary sodium as a cardiovascular risk factor (time frame: immediately after watching the video). 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 NCT05735457, which also lists 2 linked publications.
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 10 May 2023.