Ignite Creation Date:
2025-12-24 @ 6:39 PM
Ignite Modification Date:
2025-12-29 @ 5:42 AM
Study NCT ID:
NCT05735457
Status:
UNKNOWN
Last Update Posted:
2023-05-10
First Post:
2023-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Short, Animated Storytelling Video to Increase Knowledge About Sodium Intake as a Cardiovascular Risk Factor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006955', 'term': 'Hypernatremia'}], 'ancestors': [{'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-09', 'studyFirstSubmitDate': '2023-01-31', 'studyFirstSubmitQcDate': '2023-02-09', 'lastUpdatePostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immediate effect of the short, animated storytelling intervention video on knowledge about dietary sodium as a cardiovascular risk factor', 'timeFrame': 'immediately after watching the video', '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.'}, {'measure': 'Medium-term effect of the short, animated storytelling intervention video on knowledge about dietary sodium as a cardiovascular risk factor', 'timeFrame': '2 weeks after watching the video', '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.'}], 'secondaryOutcomes': [{'measure': 'Immediate effect of the short, animated storytelling intervention video on behavioral expectation to reduce dietary sodium.', 'timeFrame': 'immediately after watching the video', '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.'}, {'measure': 'Medium-term effect of the short, animated storytelling intervention video on behavioral expectation to reduce dietary sodium.', 'timeFrame': '2 weeks after watching the video', '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.'}, {'measure': 'Voluntary post-trial engagement (frequency) with the video content.', 'timeFrame': '2 weeks after entering the trial', 'description': 'Assessment of the frequency (absolute number) of watching the trial videos after completion of the trial questionnaires'}, {'measure': 'Voluntary post-trial engagement (duration) with the video content.', 'timeFrame': '2 weeks after entering the trial', 'description': 'Assessment of the duration (in minutes) of watching the trial videos after completion of the trial questionnaires'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sodium Excess', 'Cardiovascular Risk Factor', 'Education Entertainment Intervention', 'Short, Animated Storytelling']}, 'referencesModule': {'references': [{'pmid': '37296468', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nIn 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Registration with the Prolific Academic platform\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT05735457', 'briefTitle': 'A Short, Animated Storytelling Video to Increase Knowledge About Sodium Intake as a Cardiovascular Risk Factor', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Freiburg'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'EduEntertainSodium_23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention 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.\n\nTwo weeks later, participants will once again be asked to complete the knowledge and behavioral expectation questionnaire.', 'interventionNames': ['Other: A short, animated storytelling video on dietary sodium']}, {'type': 'NO_INTERVENTION', 'label': 'Exposed Control 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.\n\nTwo weeks later, participants will once again be asked to complete the knowledge and behavioral expectation questionnaire.'}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Attention Placebo Control 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.\n\nTwo weeks later, participants will once again be asked to complete the knowledge and behavioral expectation questionnaire.', 'interventionNames': ['Other: A short, animated storytelling attention placebo video']}, {'type': 'NO_INTERVENTION', 'label': 'Un-exposed Control Arm', 'description': 'Participants will not view a video and will not be asked to complete the questionnaire.\n\nTwo weeks later, participants will once again be asked to complete the knowledge and behavioral expectation questionnaire.'}], 'interventions': [{'name': 'A short, animated storytelling video on dietary sodium', 'type': 'OTHER', '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.', 'armGroupLabels': ['Intervention Arm']}, {'name': 'A short, animated storytelling attention placebo video', 'type': 'OTHER', 'description': 'The Attention Placebo Control Arm will view an attention placebo control video, unrelated to the outcomes measured in this trial.', 'armGroupLabels': ['Attention Placebo Control Arm']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Alexander Supady, MD, MPH', 'role': 'CONTACT', 'email': 'alexander.supady@uniklinik-freiburg.de', 'phone': '+4976127073790'}, {'name': 'Maya Adam, MD', 'role': 'CONTACT', 'email': 'madam@stanford.edu', 'phone': '+1 650 839 3600'}], 'overallOfficials': [{'name': 'Till Bärnighausen, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heidelberg University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Freiburg', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stanford University', 'class': 'OTHER'}, {'name': 'Heidelberg University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Physician', 'investigatorFullName': 'PD Dr. Alexander Supady', 'investigatorAffiliation': 'University Hospital Freiburg'}}}}