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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Risk Factor; Sodium Excess; Education Entertainment Intervention; Short, Animated Storytelling
• Intervention / Treatment: Other: A short, animated storytelling video on dietary sodium; Other: A short, animated storytelling attention placebo video

• Study Type: Interventional
• Enrollment (Anticipated): 10000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maya Adam, MD; Phone Number: +1 650 839 3600; Email: madam@stanford.edu
• Study Contact Backup: Name: Alexander Supady, MD, MPH; Phone Number: +4976127073790; Email: alexander.supady@uniklinik-freiburg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Registration with the Prolific Academic platform

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; 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 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.
No Intervention: Exposed Control Arm; 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.
Placebo Comparator: Attention Placebo Control Arm; 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; The Attention Placebo Control Arm will view an attention placebo control video, unrelated to the outcomes measured in this trial.
No Intervention: Un-exposed Control Arm; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital Freiburg
• Collaborators: Stanford University; Heidelberg University
• Investigators: Principal Investigator: Till Bärnighausen, Prof. Dr., Heidelberg University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): July 31, 2023
• Study Completion (Anticipated): August 31, 2023

Study Registration Dates

• First Submitted: January 31, 2023
• First Submitted That Met QC Criteria: February 9, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Water-Electrolyte Imbalance; Hypernatremia
• Other Study ID Numbers: EduEntertainSodium_23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No