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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05735457
Other study ID # EduEntertainSodium_23
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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