Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT06088251
Status:
COMPLETED
Last Update Posted:
2024-05-09
First Post:
2023-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Nutrition Training Augmented With Digital Technology in Graduate Medical Education
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002908', 'term': 'Chronic Disease'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2023-10-11', 'studyFirstSubmitQcDate': '2023-10-11', 'lastUpdatePostDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Physician Diet Counseling Outcome Expectations', 'timeFrame': 'Resident pre-assessment and post-assessment, expected to be 2 weeks after enrollment', 'description': 'Self-report of diet counseling outcome expectations; 5-point Likert-like scale; higher score means better outcome.'}, {'measure': 'Semi-structured debrief interview', 'timeFrame': 'Post-hoc analysis of simulation activity, expected to be at 2 weeks after training intervention', 'description': "Semi-structured debrief interview to better understand the resident's experience and feedback on the training session and simulation activity."}, {'measure': 'Training Satisfaction', 'timeFrame': 'Resident post-assessment, expected to be 2 weeks after enrollment', 'description': 'Self-report of satisfaction with training; 5-point Likert-like scale scale; higher score means a better outcome.'}], 'primaryOutcomes': [{'measure': 'Diet Counseling Competence', 'timeFrame': 'Resident pre-assessment and post-assessment, expected to be 2 weeks after enrollment', 'description': 'Self-report of diet counseling competency; 4-point Likert-like scale scale; higher score means better outcome'}, {'measure': 'Diet Counseling Self-Efficacy', 'timeFrame': 'Resident pre-assessment and post-assessment, expected to be 2 weeks after enrollment', 'description': 'Self-report of confidence (self-efficacy) in diet counseling; 4-point Likert-like scale scale; higher score means a better outcome.'}, {'measure': 'Diet Counseling Skills', 'timeFrame': 'Post-hoc analysis of simulation activity, expected to be at 2 weeks after training intervention', 'description': 'We will also use an observation checklist to systematically capture resident shared decision-making and diet counseling skills. We will create this checklist based on a literature review of similar tools, such as the Shared Decision Making (SDM) SDM-9 and the coding scheme described in Alexander 2011. Higher score indicates a better outcome. Score range will be reported once the scale has been finalized.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Medical Education', 'Nutrition Counseling', 'Technology'], 'conditions': ['Chronic Disease']}, 'referencesModule': {'references': [{'pmid': '21380950', 'type': 'BACKGROUND', 'citation': "Alexander SC, Cox ME, Boling Turer CL, Lyna P, Ostbye T, Tulsky JA, Dolor RJ, Pollak KI. Do the five A's work when physicians counsel about weight loss? Fam Med. 2011 Mar;43(3):179-84."}, {'pmid': '18612746', 'type': 'BACKGROUND', 'citation': 'Jay M, Gillespie C, Ark T, Richter R, McMacken M, Zabar S, Paik S, Messito MJ, Lee J, Kalet A. Do internists, pediatricians, and psychiatrists feel competent in obesity care?: using a needs assessment to drive curriculum design. J Gen Intern Med. 2008 Jul;23(7):1066-70. doi: 10.1007/s11606-008-0519-y.'}, {'pmid': '19879711', 'type': 'BACKGROUND', 'citation': 'Kriston L, Scholl I, Holzel L, Simon D, Loh A, Harter M. The 9-item Shared Decision Making Questionnaire (SDM-Q-9). Development and psychometric properties in a primary care sample. Patient Educ Couns. 2010 Jul;80(1):94-9. doi: 10.1016/j.pec.2009.09.034. Epub 2009 Oct 30.'}, {'pmid': '18689561', 'type': 'BACKGROUND', 'citation': 'Vetter ML, Herring SJ, Sood M, Shah NR, Kalet AL. What do resident physicians know about nutrition? An evaluation of attitudes, self-perceived proficiency and knowledge. J Am Coll Nutr. 2008 Apr;27(2):287-98. doi: 10.1080/07315724.2008.10719702.'}]}, 'descriptionModule': {'briefSummary': 'Investigators will conduct a randomized controlled evaluation of standard nutrition education vs. standard education + Nutri, and interactive clinical software that automates diet assessment and guides resident physicians through personalized and evidence-based diet counseling. Investigators will evaluate differences in resident-reported diet counseling competence and self-efficacy using survey measures. Investigators will evaluate skills using a simulated patient appointment and coding scheme described in prior work.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Dell Medical School Internal Medicine Residents\n* Dell Medical School Family Medicine Residents\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT06088251', 'briefTitle': 'Evaluation of Nutrition Training Augmented With Digital Technology in Graduate Medical Education', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas at Austin'}, 'officialTitle': 'Evaluation of Nutrition Training Augmented With Digital Technology in Graduate Medical Education', 'orgStudyIdInfo': {'id': '00005155'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nutri Training', 'description': 'Nutri Training will begin with 1) a presentation of diet counseling evidence and best practices for advising patients, along with information about nutrition recommendations for patients with chronic illness and 2) tools supporting the patient for follow-up. This content will be delivered via a live demonstration of the Nutri interactive software and case demonstration, a novel approach to delivering the learning objectives of standard nutrition education for residents.', 'interventionNames': ['Behavioral: Nutri Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Nutrition Education', 'description': 'Standard Nutrition Training will present an overview of 1) nutrition recommendations for patients with chronic disease and 2) cover the role of a registered dietitian and referrals.', 'interventionNames': ['Behavioral: Standard Nutrition Education']}], 'interventions': [{'name': 'Nutri Training', 'type': 'BEHAVIORAL', 'description': 'Nutri Training will begin with 1) a presentation of diet counseling evidence and best practices for advising patients, along with information about nutrition recommendations for patients with chronic illness and 2) tools supporting the patient for follow-up. This content will be delivered via a live demonstration of the Nutri interactive software and case demonstration, a novel approach to delivering the learning objectives of standard nutrition education for residents.', 'armGroupLabels': ['Nutri Training']}, {'name': 'Standard Nutrition Education', 'type': 'BEHAVIORAL', 'description': 'Standard Nutrition Education Standard Nutrition Training will present an overview of 1) nutrition recommendations for patients with chronic disease and 2) cover the role of a registered dietitian and referrals.', 'armGroupLabels': ['Standard Nutrition Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas at Austin - Burgermaster Lab', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Marissa Burgermaster, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas at Austin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas at Austin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}