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

Sponsor
University Hospital Freiburg (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05735457
Collaborator
Stanford University (Other), Heidelberg University (Other)
10,000
4
5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: A short, animated storytelling video on dietary sodium
  • Other: A short, animated storytelling attention placebo video
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
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
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
May 31, 2023
Anticipated Study Completion Date :
Jul 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Immediate effect of the short, animated storytelling intervention video on knowledge about dietary sodium as a cardiovascular risk factor [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.

  2. Medium-term effect of the short, animated storytelling intervention video on knowledge about dietary sodium as a cardiovascular risk factor [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.

Secondary Outcome Measures

  1. Immediate effect of the short, animated storytelling intervention video on behavioral expectation to reduce dietary sodium. [immediately after watching the video]

    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.

  2. Medium-term effect of the short, animated storytelling intervention video on behavioral expectation to reduce dietary sodium. [2 weeks after watching the video]

    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.

  3. Voluntary post-trial engagement (frequency) with the video content. [2 weeks after entering the trial]

    Assessment of the frequency (absolute number) of watching the trial videos after completion of the trial questionnaires

  4. Voluntary post-trial engagement (duration) with the video content. [2 weeks after entering the trial]

    Assessment of the duration (in minutes) of watching the trial videos after completion of the trial questionnaires

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 59 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Registration with the Prolific Academic platform
Exclusion Criteria:
  • none

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital Freiburg
  • Stanford University
  • Heidelberg University

Investigators

  • Principal Investigator: Till Bärnighausen, Prof. Dr., Heidelberg University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Alexander Supady, Attending Physician, University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT05735457
Other Study ID Numbers:
  • EduEntertainSodium_23
First Posted:
Feb 21, 2023
Last Update Posted:
Feb 21, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 21, 2023