An interventional study of A short, animated storytelling video on dietary sodium and A short, animated storytelling attention placebo video in Sodium Excess, Cardiovascular Risk Factor and Education Entertainment Intervention, sponsored by University Hospital Freiburg. Not yet recruiting. Open to participants aged 18 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-10.
Sponsored by University Hospital Freiburg · Not applicable, Interventional, and Prevention
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.
49 studies on the registry are indexed under Hypernatremia; 8 are open to participants now.
This study's planned enrollment of 10,000 is above the median of 64 across 32 interventional studies indexed under Hypernatremia.
Browse Hypernatremia studies →University Hospital Freiburg is the lead sponsor of 94 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
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.
Other: A short, animated storytelling video on dietary sodium
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.
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.
Other: A short, animated storytelling attention placebo video
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.
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.
The Attention Placebo Control Arm will view an attention placebo control video, unrelated to the outcomes measured in this trial.
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.
Time frame: 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.
Time frame: 2 weeks after watching the video
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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 2 weeks after entering the trial
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jun 2023; primary completion for Jul 2023, 1 month later.
Of 12 interventional studies with no phase under Hypernatremia, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's planned 1 month is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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University Hospital Freiburg