Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-28 @ 7:41 AM
Study NCT ID:
NCT04700904
Status:
COMPLETED
Last Update Posted:
2025-01-27
First Post:
2021-01-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PortionSize Study 1 Laboratory-based Evaluation)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005247', 'term': 'Feeding Behavior'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'corby.martin@pbrc.edu', 'phone': '763-2585', 'title': 'Corby Martin', 'organization': 'Pennington Biomedical Research Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '9 months', 'eventGroups': [{'id': 'EG000', 'title': 'All Participants', 'description': 'all 42 participants that completed the study', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 0, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Difference in Simulated Energy (kcal) Intake Between the Criterion Measure (Weighed Food) and Two Smartphone Apps (PortionSize and MyFitness Pal).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PortionSize App', 'description': 'Dietary tracking completed using a novel mobile app that relies on food photography to provide immediate feedback to the user on energy (kcals), food groups, alcohol, saturated fat, and added sugar intake.'}, {'id': 'OG001', 'title': 'MyFitnessPal App', 'description': 'Dietary tracking completed using a commercial-based dietary assessment application with associated website'}], 'classes': [{'categories': [{'measurements': [{'value': '-150.1', 'spread': '489.5', 'groupId': 'OG000'}, {'value': '79.8', 'spread': '583.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2.5 hours', 'description': 'The outcome variable was the difference between the criterion measure (directly weighed foods from a simulated lunch meal) and two apps: PortionSize and MyFitnessPal. The outcome measure for the PortionSize app was calculated as: energy intake values from PortionSize minus energy intake values from weighed foods. The outcome measure for the MyFitnessPal app was calculated as: energy intake values from MyFitnessPal minus energy intake values from weighed foods.', 'unitOfMeasure': 'kcal', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants completed the study protocols using the PortionSize app and the MyFitnessPal app across two study visits (1 app at each visit). Groups defined in the participant progression section distinguish participants who used the PortionSize app first from those who used the MyFitnessPal app first.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MyFitnessPal (V1) PortionSize (V2)', 'description': 'MyFitnessPal app: Dietary tracking completed using a commercial-based dietary assessment application with associated website\n\nPortion Size app: Dietary tracking completed using a novel mobile app that relies on food photography to provide immediate feedback to the user on energy (kcals), food groups, alcohol, saturated fat, and added sugar intake.'}, {'id': 'FG001', 'title': 'PortionSize (V1) MyFitnessPal (V2)', 'description': 'Portion Size app: Dietary tracking completed using a novel mobile app that relies on food photography to provide immediate feedback to the user on energy (kcals), food groups, alcohol, saturated fat, and added sugar intake.\n\nMyFitnessPal app: Dietary tracking completed using a commercial-based dietary assessment application with associated website'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'all 42 participants that completed the study'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.3', 'spread': '16.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '81.5', 'spread': '22.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '28.2', 'spread': '6.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'all 42 participants who completed the study'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-03', 'size': 316702, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-10-25T13:28', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-23', 'studyFirstSubmitDate': '2021-01-06', 'resultsFirstSubmitDate': '2024-10-31', 'studyFirstSubmitQcDate': '2021-01-07', 'lastUpdatePostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-23', 'studyFirstPostDateStruct': {'date': '2021-01-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in Simulated Energy (kcal) Intake Between the Criterion Measure (Weighed Food) and Two Smartphone Apps (PortionSize and MyFitness Pal).', 'timeFrame': '2.5 hours', 'description': 'The outcome variable was the difference between the criterion measure (directly weighed foods from a simulated lunch meal) and two apps: PortionSize and MyFitnessPal. The outcome measure for the PortionSize app was calculated as: energy intake values from PortionSize minus energy intake values from weighed foods. The outcome measure for the MyFitnessPal app was calculated as: energy intake values from MyFitnessPal minus energy intake values from weighed foods.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dietary Habits']}, 'referencesModule': {'references': [{'pmid': '38825184', 'type': 'DERIVED', 'citation': 'Lozano CP, Neubig KE, Saha S, Broyles ST, Apolzan JW, Martin CK. Validity of the PortionSize application compared with that of MyFitnessPal for accurately estimating intake: a randomized crossover laboratory-based evaluation. Am J Clin Nutr. 2024 Aug;120(2):419-430. doi: 10.1016/j.ajcnut.2024.05.023. Epub 2024 May 31.'}]}, 'descriptionModule': {'briefSummary': 'The objective is to test the accuracy and user satisfaction of the PortionSize™ app and the MyFitnessPal© app during laboratory controlled test meals.', 'detailedDescription': "Accurately quantifying food intake is vital to promoting health and reducing chronic disease risk. Food intake encompasses energy intake, nutrient intake (macronutrients, micronutrients, vitamins, minerals), and intake of various food groups (e.g., fruits, vegetables), and thus reflects the nutritional status of individuals. Nutrition affects disease risk, including risk of developing obesity, diabetes, and cancer, all of which negatively affect the United States (U.S). Nonetheless, accurate assessment of food and nutrient intake has remained challenging, despite an improvement in methods. Self report methods, namely food records, are a mainstay of nutritional epidemiology research, with food recall being another popular method. These methods rely on the participant to accurately estimate portion size and, for food recall, remember what was consumed. The accuracy of these methods have been questioned and the problems with human recall have been comprehensively outlined. As a result, there remains a significant need for methods that are sufficiently accurate to provide researchers with good outcome data and to guide health promotion efforts.\n\nThe PortionSize™ app was designed by our laboratory to overcome the limitations outlined above, and to guide users to follow specific diets. PortionSize relies on users capturing images of their food selection and waste. Food intake data are immediately provided since the user relies on built in tools, including templates, to estimate portion size. However, despite promising early indications, the PortionSize app's validity has yet to be extensively tested. Determining the accuracy of PortionSize is vital before users can utilize the app to obtain immediate feedback about their food intake. We accordingly aim to test the validity of PortionSize in a controlled laboratory setting. We will also test the validity of the MyFitnessPal© app, which is similar to an electronic food record."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy participants ages 18 to 70 in the Baton Rouge, LA area.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, age 18-70 years\n* Body mass index (BMI) 18.5 - 50\n* Ownership of an iPhone model 6s or later, which the participant is willing to use for the study\n* Access to Apple ID, password, and email address and willing to use them in the course of the study\n* Willing to use data and any accompanying charges as part of study participation\n* Willing to be re-contacted for future research and/or follow-up\n\nExclusion Criteria:\n\n* Center employee\n* Any condition or circumstance that could impede study completion'}, 'identificationModule': {'nctId': 'NCT04700904', 'briefTitle': 'PortionSize Study 1 Laboratory-based Evaluation)', 'organization': {'class': 'OTHER', 'fullName': 'Pennington Biomedical Research Center'}, 'officialTitle': 'The Reliability and Validity of the PortionSize and MyFitnessPal Apps (Study 1: Laboratory-based Evaluation)', 'orgStudyIdInfo': {'id': 'PBRC 2019-062'}}, 'contactsLocationsModule': {'locations': [{'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Pennington Biomedical Research', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}], 'overallOfficials': [{'name': 'John W Apolzan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pennington Biomedical Research Center'}, {'name': 'Corby K Martin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pennington Biomedical Research Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pennington Biomedical Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PBRC Professor, Director - Ingestive Behavior Laboratory', 'investigatorFullName': 'Corby K. Martin', 'investigatorAffiliation': 'Pennington Biomedical Research Center'}}}}