NCT05735457

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

2 months

First QC Date

January 31, 2023

Last Update Submit

May 9, 2023

Conditions

Sodium ExcessCardiovascular Risk FactorEducation Entertainment InterventionShort, Animated Storytelling

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Immediate effect of the short, animated storytelling intervention video on behavioral expectation to reduce dietary sodium.

    immediately after watching the video

  • Medium-term effect of the short, animated storytelling intervention video on behavioral expectation to reduce dietary sodium.

    2 weeks after watching the video

  • Voluntary post-trial engagement (frequency) with the video content.

    2 weeks after entering the trial

  • Voluntary post-trial engagement (duration) with the video content.

    2 weeks after entering the trial

Study Arms (4)

Intervention Arm

EXPERIMENTAL

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

Exposed Control Arm

NO INTERVENTION

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.

Attention Placebo Control Arm

PLACEBO COMPARATOR

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

Un-exposed Control Arm

NO INTERVENTION

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.

Interventions

A short, animated storytelling video on dietary sodiumOTHER

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 Arm
A short, animated storytelling attention placebo videoOTHER

The Attention Placebo Control Arm will view an attention placebo control video, unrelated to the outcomes measured in this trial.

Attention Placebo Control Arm

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Registration with the Prolific Academic platform

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Adam M, Rohr JK, Greuel M, Nguyen VK, El Aziz MA, Uberreiter C, Coles O, Barnighausen T, Supady A. Digital storytelling boosts knowledge and behavioral expectation to reduce dietary sodium: a randomized controlled trial. NPJ Digit Med. 2026 Jan 9;9(1):21. doi: 10.1038/s41746-025-02258-x.

    PMID: 41514069DERIVED

  • Supady A, Nguyen K, Aziz MAE, Uberreiter C, Barnighausen T, Adam M. A short, animated storytelling video about sodium intake as a major cardiovascular risk factor and recommendations for a healthy diet: an online, randomized, controlled trial. Trials. 2023 Jun 10;24(1):390. doi: 10.1186/s13063-023-07418-6.

    PMID: 37296468DERIVED

MeSH Terms

Conditions

Hypernatremia

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Till Bärnighausen, Prof. Dr.

    Heidelberg University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Supady, MD, MPH

CONTACT

+4976127073790alexander.supady@uniklinik-freiburg.de

Maya Adam, MD

CONTACT

+1 650 839 3600madam@stanford.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

January 31, 2023

First Posted

February 21, 2023

Study Start

June 1, 2023

Primary Completion

July 31, 2023

Study Completion

August 31, 2023

Last Updated

May 10, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share