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

Primary Purpose

Sodium Excess, Cardiovascular Risk Factor, Education Entertainment Intervention

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
A short, animated storytelling video on dietary sodium
A short, animated storytelling attention placebo video
Sponsored by
University Hospital Freiburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sodium Excess

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Registration with the Prolific Academic platform Exclusion Criteria: none

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    No Intervention

    Placebo Comparator

    No Intervention

    Arm Label

    Intervention Arm

    Exposed Control Arm

    Attention Placebo Control Arm

    Un-exposed Control Arm

    Arm Description

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    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.
    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.
    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
    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

    Full Information

    First Posted
    January 31, 2023
    Last Updated
    May 9, 2023
    Sponsor
    University Hospital Freiburg
    Collaborators
    Stanford University, Heidelberg University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05735457
    Brief Title
    A Short, Animated Storytelling Video to Increase Knowledge About Sodium Intake as a Cardiovascular Risk Factor
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    July 31, 2023 (Anticipated)
    Study Completion Date
    August 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Hospital Freiburg
    Collaborators
    Stanford University, Heidelberg University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sodium Excess, Cardiovascular Risk Factor, Education Entertainment Intervention, Short, Animated Storytelling

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    10000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Arm
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Exposed Control Arm
    Arm Type
    No Intervention
    Arm Description
    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.
    Arm Title
    Attention Placebo Control Arm
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Arm Title
    Un-exposed Control Arm
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    A short, animated storytelling video on dietary sodium
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    A short, animated storytelling attention placebo video
    Intervention Description
    The Attention Placebo Control Arm will view an attention placebo control video, unrelated to the outcomes measured in this trial.
    Primary Outcome Measure Information:
    Title
    Immediate effect of the short, animated storytelling intervention video on knowledge about dietary sodium as a cardiovascular risk factor
    Description
    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
    Title
    Medium-term effect of the short, animated storytelling intervention video on knowledge about dietary sodium as a cardiovascular risk factor
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Immediate effect of the short, animated storytelling intervention video on behavioral expectation to reduce dietary sodium.
    Description
    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
    Title
    Medium-term effect of the short, animated storytelling intervention video on behavioral expectation to reduce dietary sodium.
    Description
    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
    Title
    Voluntary post-trial engagement (frequency) with the video content.
    Description
    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
    Title
    Voluntary post-trial engagement (duration) with the video content.
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    59 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Registration with the Prolific Academic platform Exclusion Criteria: none
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alexander Supady, MD, MPH
    Phone
    +4976127073790
    Email
    alexander.supady@uniklinik-freiburg.de
    First Name & Middle Initial & Last Name or Official Title & Degree
    Maya Adam, MD
    Phone
    +1 650 839 3600
    Email
    madam@stanford.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Till Bärnighausen, Prof. Dr.
    Organizational Affiliation
    Heidelberg University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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