A Short, Animated Storytelling Video to Increase Knowledge About Sodium Intake as a Cardiovascular Risk Factor

Cardiovascular Risk Factor Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05735457
• Other study ID #: EduEntertainSodium_23
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: August 31, 2023

Study information

• Verified date: May 2023
• Source: University Hospital Freiburg
• Contact: Alexander Supady, MD, MPH
• Phone: +4976127073790
• Email: alexander.supady[@]uniklinik-freiburg.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10000
• Est. completion date: August 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

Inclusion Criteria:

• Registration with the Prolific Academic platform

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Hypernatremia
• Sodium Excess

Intervention

Other:
• A short, animated storytelling video on dietary sodium
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 video
The Attention Placebo Control Arm will view an attention placebo control video, unrelated to the outcomes measured in this trial.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Freiburg	Heidelberg University, Stanford University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	immediately after watching the video
Primary	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.	2 weeks after watching the video
Secondary	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.	immediately after watching the video
Secondary	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.	2 weeks after watching the video
Secondary	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	2 weeks after entering the trial
Secondary	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	2 weeks after entering the trial