Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-18 @ 1:55 PM
Study NCT ID:
NCT03267004
Status:
COMPLETED
Last Update Posted:
2025-04-08
First Post:
2017-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dietary Assessment Study Via Digital Images
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': 'hraynor@utk.edu', 'phone': '865-974-6259', 'title': 'Hollie Raynor', 'organization': 'University of Tennessee'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '4 weeks of participation', 'eventGroups': [{'id': 'EG000', 'title': 'Meal Order 1', 'description': 'Meal A will be served to participant in meal session 1 and Meal B in meal session 2.\n\nDietary Assessment of Meal A using images taken by Sony Smarteyeglass: Participant will be wearing Sony Smarteyeglass to record digital images while eating meal A in the laboratory\n\nMeal A:\n\nTurkey and Provolone Cheese Sandwich \\[whole wheat bread 52g(female \\& male), Turkey 70g(female) \\& 133g(male), Provolone cheese 23g(female \\& male), tomato 50g(female \\& male), lettuce 45g(female \\& male)\\]; Chicken and wild rice \\[chicken 98g(female \\& male), wild rice 71g(female) \\& 107g(male)\\]; chocolate chips cookies \\[44g(female) \\& 60.5g(male)\\]; potato chips \\[39g(female) \\& 52g(male)\\].\n\nDietary Assessment of Meal B using Images taken by Sony Smarteyeglass: Participant will be wearing Sony Smarteyeglass to record digital images while eating meal B in the laboratory\n\nMeal B:\n\nHam \\& Cheddar cheese wrap \\[Tortilla 45g(female \\& male), Ham deli 76g(female) \\& 103g(male), cheddar cheese 21g(female) \\& 32g(male), Spring Mix 36g(female \\& male), Fat Free ranch dressing 29g(female \\& male)\\]; Pasta with broccoli and Alfredo sauce \\[Pasta 91g(female) \\& 121g(male), Broccoli 66g(female \\& male), Alfredo sauce 38g(female) \\& 50g(male)\\]; Chocolate Ice-cream \\[107g(female), 138g(male)\\]; Red seedless grapes \\[365g (female), 471g(male)\\].', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Meal Order 2', 'description': 'Meal B will be served to participant in meal session 1 and Meal A in meal session 2.\n\nDietary Assessment of Meal A using images taken by Sony Smarteyeglass: Participant will be wearing Sony Smarteyeglass to record digital images while eating meal A in the laboratory\n\nMeal A:\n\nTurkey and Provolone Cheese Sandwich \\[whole wheat bread 52g(female \\& male), Turkey 70g(female) \\& 133g(male), Provolone cheese 23g(female \\& male), tomato 50g(female \\& male), lettuce 45g(female \\& male)\\]; Chicken and wild rice \\[chicken 98g(female \\& male), wild rice 71g(female) \\& 107g(male)\\]; chocolate chips cookies \\[44g(female) \\& 60.5g(male)\\]; potato chips \\[39g(female) \\& 52g(male)\\].\n\nDietary Assessment of Meal B using Images taken by Sony Smarteyeglass: Participant will be wearing Sony Smarteyeglass to record digital images while eating meal B in the laboratory\n\nMeal B:\n\nHam \\& Cheddar cheese wrap \\[Tortilla 45g(female \\& male), Ham deli 76g(female) \\& 103g(male), cheddar cheese 21g(female) \\& 32g(male), Spring Mix 36g(female \\& male), Fat Free ranch dressing 29g(female \\& male)\\]; Pasta with broccoli and Alfredo sauce \\[Pasta 91g(female) \\& 121g(male), Broccoli 66g(female \\& male), Alfredo sauce 38g(female) \\& 50g(male)\\]; Chocolate Ice-cream \\[107g(female), 138g(male)\\]; Red seedless grapes \\[365g (female), 471g(male)\\].', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Weighed Food Intake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meal Order 1', 'description': 'Meal A will be served to participant in meal session 1 and Meal B in meal session 2.\n\nDietary Assessment of Meal A using images taken by Sony Smarteyeglass: Participant will be wearing Sony Smarteyeglass to record digital images while eating meal A in the laboratory\n\nMeal A:\n\nTurkey and Provolone Cheese Sandwich \\[whole wheat bread 52g(female \\& male), Turkey 70g(female) \\& 133g(male), Provolone cheese 23g(female \\& male), tomato 50g(female \\& male), lettuce 45g(female \\& male)\\]; Chicken and wild rice \\[chicken 98g(female \\& male), wild rice 71g(female) \\& 107g(male)\\]; chocolate chips cookies \\[44g(female) \\& 60.5g(male)\\]; potato chips \\[39g(female) \\& 52g(male)\\].\n\nDietary Assessment of Meal B using Images taken by Sony Smarteyeglass: Participant will be wearing Sony Smarteyeglass to record digital images while eating meal B in the laboratory\n\nMeal B:\n\nHam \\& Cheddar cheese wrap \\[Tortilla 45g(female \\& male), Ham deli 76g(female) \\& 103g(male), cheddar cheese 21g(female) \\& 32g(male), Spring Mix 36g(female \\& male), Fat Free ranch dressing 29g(female \\& male)\\]; Pasta with broccoli and Alfredo sauce \\[Pasta 91g(female) \\& 121g(male), Broccoli 66g(female \\& male), Alfredo sauce 38g(female) \\& 50g(male)\\]; Chocolate Ice-cream \\[107g(female), 138g(male)\\]; Red seedless grapes \\[365g (female), 471g(male)\\].'}, {'id': 'OG001', 'title': 'Meal Order 2', 'description': 'Meal B will be served to participant in meal session 1 and Meal A in meal session 2.\n\nDietary Assessment of Meal A using images taken by Sony Smarteyeglass: Participant will be wearing Sony Smarteyeglass to record digital images while eating meal A in the laboratory\n\nMeal A:\n\nTurkey and Provolone Cheese Sandwich \\[whole wheat bread 52g(female \\& male), Turkey 70g(female) \\& 133g(male), Provolone cheese 23g(female \\& male), tomato 50g(female \\& male), lettuce 45g(female \\& male)\\]; Chicken and wild rice \\[chicken 98g(female \\& male), wild rice 71g(female) \\& 107g(male)\\]; chocolate chips cookies \\[44g(female) \\& 60.5g(male)\\]; potato chips \\[39g(female) \\& 52g(male)\\].\n\nDietary Assessment of Meal B using Images taken by Sony Smarteyeglass: Participant will be wearing Sony Smarteyeglass to record digital images while eating meal B in the laboratory\n\nMeal B:\n\nHam \\& Cheddar cheese wrap \\[Tortilla 45g(female \\& male), Ham deli 76g(female) \\& 103g(male), cheddar cheese 21g(female) \\& 32g(male), Spring Mix 36g(female \\& male), Fat Free ranch dressing 29g(female \\& male)\\]; Pasta with broccoli and Alfredo sauce \\[Pasta 91g(female) \\& 121g(male), Broccoli 66g(female \\& male), Alfredo sauce 38g(female) \\& 50g(male)\\]; Chocolate Ice-cream \\[107g(female), 138g(male)\\]; Red seedless grapes \\[365g (female), 471g(male)\\].'}], 'classes': [{'categories': [{'measurements': [{'value': '354.4', 'spread': '126.2', 'groupId': 'OG000'}, {'value': '354.4', 'spread': '126.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Meal session 1 and 2 within 4 weeks of initial screening session', 'description': 'Before and after each meal session, each food items will be weighed to the nearest tenth of a gram using an electronic food scale. Assessing the weight change of food intake.', 'unitOfMeasure': 'grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': '24-hour Dietary Recall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meal Order 1', 'description': 'Meal A will be served to participant in meal session 1 and Meal B in meal session 2.\n\nDietary Assessment of Meal A using images taken by Sony Smarteyeglass: Participant will be wearing Sony Smarteyeglass to record digital images while eating meal A in the laboratory\n\nMeal A:\n\nTurkey and Provolone Cheese Sandwich \\[whole wheat bread 52g(female \\& male), Turkey 70g(female) \\& 133g(male), Provolone cheese 23g(female \\& male), tomato 50g(female \\& male), lettuce 45g(female \\& male)\\]; Chicken and wild rice \\[chicken 98g(female \\& male), wild rice 71g(female) \\& 107g(male)\\]; chocolate chips cookies \\[44g(female) \\& 60.5g(male)\\]; potato chips \\[39g(female) \\& 52g(male)\\].\n\nDietary Assessment of Meal B using Images taken by Sony Smarteyeglass: Participant will be wearing Sony Smarteyeglass to record digital images while eating meal B in the laboratory\n\nMeal B:\n\nHam \\& Cheddar cheese wrap \\[Tortilla 45g(female \\& male), Ham deli 76g(female) \\& 103g(male), cheddar cheese 21g(female) \\& 32g(male), Spring Mix 36g(female \\& male), Fat Free ranch dressing 29g(female \\& male)\\]; Pasta with broccoli and Alfredo sauce \\[Pasta 91g(female) \\& 121g(male), Broccoli 66g(female \\& male), Alfredo sauce 38g(female) \\& 50g(male)\\]; Chocolate Ice-cream \\[107g(female), 138g(male)\\]; Red seedless grapes \\[365g (female), 471g(male)\\].'}, {'id': 'OG001', 'title': 'Meal Order 2', 'description': 'Meal B will be served to participant in meal session 1 and Meal A in meal session 2.\n\nDietary Assessment of Meal A using images taken by Sony Smarteyeglass: Participant will be wearing Sony Smarteyeglass to record digital images while eating meal A in the laboratory\n\nMeal A:\n\nTurkey and Provolone Cheese Sandwich \\[whole wheat bread 52g(female \\& male), Turkey 70g(female) \\& 133g(male), Provolone cheese 23g(female \\& male), tomato 50g(female \\& male), lettuce 45g(female \\& male)\\]; Chicken and wild rice \\[chicken 98g(female \\& male), wild rice 71g(female) \\& 107g(male)\\]; chocolate chips cookies \\[44g(female) \\& 60.5g(male)\\]; potato chips \\[39g(female) \\& 52g(male)\\].\n\nDietary Assessment of Meal B using Images taken by Sony Smarteyeglass: Participant will be wearing Sony Smarteyeglass to record digital images while eating meal B in the laboratory\n\nMeal B:\n\nHam \\& Cheddar cheese wrap \\[Tortilla 45g(female \\& male), Ham deli 76g(female) \\& 103g(male), cheddar cheese 21g(female) \\& 32g(male), Spring Mix 36g(female \\& male), Fat Free ranch dressing 29g(female \\& male)\\]; Pasta with broccoli and Alfredo sauce \\[Pasta 91g(female) \\& 121g(male), Broccoli 66g(female \\& male), Alfredo sauce 38g(female) \\& 50g(male)\\]; Chocolate Ice-cream \\[107g(female), 138g(male)\\]; Red seedless grapes \\[365g (female), 471g(male)\\].'}], 'classes': [{'categories': [{'measurements': [{'value': '302.6', 'spread': '132.6', 'groupId': 'OG000'}, {'value': '302.6', 'spread': '132.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The following day of meal session 1 and 2 within 4 weeks of initial screening session', 'description': 'On the following day of each meal session, the investigator will ask the participant to recall their dietary intake by having the participant reporting all foods and beverages consumed and the time in which they consumed these items within the past 24 hours. Participants will be asked what time of day the foods and beverages were consumed and will be shown two-dimensional food shapes to help with estimating portion sizes. Only dietary intake for the meal session will be entered into NDS-R to convert to commonly used measurements.', 'unitOfMeasure': 'grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Meal Order 1', 'description': 'Meal A will be served to participant in meal session 1 and Meal B in meal session 2.\n\nDietary Assessment of Meal A using images taken by Sony Smarteyeglass: Participant will be wearing Sony Smarteyeglass to record digital images while eating meal A in the laboratory\n\nMeal A:\n\nTurkey and Provolone Cheese Sandwich \\[whole wheat bread 52g(female \\& male), Turkey 70g(female) \\& 133g(male), Provolone cheese 23g(female \\& male), tomato 50g(female \\& male), lettuce 45g(female \\& male)\\]; Chicken and wild rice \\[chicken 98g(female \\& male), wild rice 71g(female) \\& 107g(male)\\]; chocolate chips cookies \\[44g(female) \\& 60.5g(male)\\]; potato chips \\[39g(female) \\& 52g(male)\\].\n\nDietary Assessment of Meal B using Images taken by Sony Smarteyeglass: Participant will be wearing Sony Smarteyeglass to record digital images while eating meal B in the laboratory\n\nMeal B:\n\nHam \\& Cheddar cheese wrap \\[Tortilla 45g(female \\& male), Ham deli 76g(female) \\& 103g(male), cheddar cheese 21g(female) \\& 32g(male), Spring Mix 36g(female \\& male), Fat Free ranch dressing 29g(female \\& male)\\]; Pasta with broccoli and Alfredo sauce \\[Pasta 91g(female) \\& 121g(male), Broccoli 66g(female \\& male), Alfredo sauce 38g(female) \\& 50g(male)\\]; Chocolate Ice-cream \\[107g(female), 138g(male)\\]; Red seedless grapes \\[365g (female), 471g(male)\\].'}, {'id': 'FG001', 'title': 'Meal Order 2', 'description': 'Meal B will be served to participant in meal session 1 and Meal A in meal session 2.\n\nDietary Assessment of Meal A using images taken by Sony Smarteyeglass: Participant will be wearing Sony Smarteyeglass to record digital images while eating meal A in the laboratory\n\nMeal A:\n\nTurkey and Provolone Cheese Sandwich \\[whole wheat bread 52g(female \\& male), Turkey 70g(female) \\& 133g(male), Provolone cheese 23g(female \\& male), tomato 50g(female \\& male), lettuce 45g(female \\& male)\\]; Chicken and wild rice \\[chicken 98g(female \\& male), wild rice 71g(female) \\& 107g(male)\\]; chocolate chips cookies \\[44g(female) \\& 60.5g(male)\\]; potato chips \\[39g(female) \\& 52g(male)\\].\n\nDietary Assessment of Meal B using Images taken by Sony Smarteyeglass: Participant will be wearing Sony Smarteyeglass to record digital images while eating meal B in the laboratory\n\nMeal B:\n\nHam \\& Cheddar cheese wrap \\[Tortilla 45g(female \\& male), Ham deli 76g(female) \\& 103g(male), cheddar cheese 21g(female) \\& 32g(male), Spring Mix 36g(female \\& male), Fat Free ranch dressing 29g(female \\& male)\\]; Pasta with broccoli and Alfredo sauce \\[Pasta 91g(female) \\& 121g(male), Broccoli 66g(female \\& male), Alfredo sauce 38g(female) \\& 50g(male)\\]; Chocolate Ice-cream \\[107g(female), 138g(male)\\]; Red seedless grapes \\[365g (female), 471g(male)\\].'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Meal Order 1', 'description': 'Meal A will be served to participant in meal session 1 and Meal B in meal session 2.\n\nDietary Assessment of Meal A using images taken by Sony Smarteyeglass: Participant will be wearing Sony Smarteyeglass to record digital images while eating meal A in the laboratory\n\nMeal A:\n\nTurkey and Provolone Cheese Sandwich \\[whole wheat bread 52g(female \\& male), Turkey 70g(female) \\& 133g(male), Provolone cheese 23g(female \\& male), tomato 50g(female \\& male), lettuce 45g(female \\& male)\\]; Chicken and wild rice \\[chicken 98g(female \\& male), wild rice 71g(female) \\& 107g(male)\\]; chocolate chips cookies \\[44g(female) \\& 60.5g(male)\\]; potato chips \\[39g(female) \\& 52g(male)\\].\n\nDietary Assessment of Meal B using Images taken by Sony Smarteyeglass: Participant will be wearing Sony Smarteyeglass to record digital images while eating meal B in the laboratory\n\nMeal B:\n\nHam \\& Cheddar cheese wrap \\[Tortilla 45g(female \\& male), Ham deli 76g(female) \\& 103g(male), cheddar cheese 21g(female) \\& 32g(male), Spring Mix 36g(female \\& male), Fat Free ranch dressing 29g(female \\& male)\\]; Pasta with broccoli and Alfredo sauce \\[Pasta 91g(female) \\& 121g(male), Broccoli 66g(female \\& male), Alfredo sauce 38g(female) \\& 50g(male)\\]; Chocolate Ice-cream \\[107g(female), 138g(male)\\]; Red seedless grapes \\[365g (female), 471g(male)\\].'}, {'id': 'BG001', 'title': 'Meal Order 2', 'description': 'Meal B will be served to participant in meal session 1 and Meal A in meal session 2.\n\nDietary Assessment of Meal A using images taken by Sony Smarteyeglass: Participant will be wearing Sony Smarteyeglass to record digital images while eating meal A in the laboratory\n\nMeal A:\n\nTurkey and Provolone Cheese Sandwich \\[whole wheat bread 52g(female \\& male), Turkey 70g(female) \\& 133g(male), Provolone cheese 23g(female \\& male), tomato 50g(female \\& male), lettuce 45g(female \\& male)\\]; Chicken and wild rice \\[chicken 98g(female \\& male), wild rice 71g(female) \\& 107g(male)\\]; chocolate chips cookies \\[44g(female) \\& 60.5g(male)\\]; potato chips \\[39g(female) \\& 52g(male)\\].\n\nDietary Assessment of Meal B using Images taken by Sony Smarteyeglass: Participant will be wearing Sony Smarteyeglass to record digital images while eating meal B in the laboratory\n\nMeal B:\n\nHam \\& Cheddar cheese wrap \\[Tortilla 45g(female \\& male), Ham deli 76g(female) \\& 103g(male), cheddar cheese 21g(female) \\& 32g(male), Spring Mix 36g(female \\& male), Fat Free ranch dressing 29g(female \\& male)\\]; Pasta with broccoli and Alfredo sauce \\[Pasta 91g(female) \\& 121g(male), Broccoli 66g(female \\& male), Alfredo sauce 38g(female) \\& 50g(male)\\]; Chocolate Ice-cream \\[107g(female), 138g(male)\\]; Red seedless grapes \\[365g (female), 471g(male)\\].'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.3', 'spread': '6.2', 'groupId': 'BG000'}, {'value': '24.8', 'spread': '7.1', 'groupId': 'BG001'}, {'value': '25.1', 'spread': '6.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'nominal scale', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2024-05-21', 'size': 146731, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-03-11T21:18', 'hasProtocol': True}, {'date': '2017-08-03', 'size': 163699, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-05-21T17:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'The project staffs who will be analyzing the digital images taken by Sony Smarteyeglass during meal sessions will be masked including the types of foods and volume provided to the participants.'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'A 2x2x2x2x3 mixed factorial design will be used, with a between-subject factor of the order of meals (Order 1 and 2) and within-subject factors of food shapes (Regular and Irregular), food complexities (Single food and Mixed food), meals (Meal A and B), and methods of measurement (DietCam, weighed food intake, and 24-hour dietary recall).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2020-06-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-01', 'studyFirstSubmitDate': '2017-08-10', 'resultsFirstSubmitDate': '2021-08-16', 'studyFirstSubmitQcDate': '2017-08-26', 'lastUpdatePostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-04', 'studyFirstPostDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weighed Food Intake', 'timeFrame': 'Meal session 1 and 2 within 4 weeks of initial screening session', 'description': 'Before and after each meal session, each food items will be weighed to the nearest tenth of a gram using an electronic food scale. Assessing the weight change of food intake.'}, {'measure': '24-hour Dietary Recall', 'timeFrame': 'The following day of meal session 1 and 2 within 4 weeks of initial screening session', 'description': 'On the following day of each meal session, the investigator will ask the participant to recall their dietary intake by having the participant reporting all foods and beverages consumed and the time in which they consumed these items within the past 24 hours. Participants will be asked what time of day the foods and beverages were consumed and will be shown two-dimensional food shapes to help with estimating portion sizes. Only dietary intake for the meal session will be entered into NDS-R to convert to commonly used measurements.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diet Habit']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'U.S. Department of Health and Human Services; U.S. Department of Agriculture. 2015-2020 Dietary guidelines for Americans. Appendix 2. Estimated Calorie Needs per Day, by Age, Sex, and Physical Activity Level 2015; 8th Edition:http://health.gov.dietaryguidelines/2015/guidelines/. Accessed April 18, 2017.'}, {'type': 'BACKGROUND', 'citation': 'Lohman TR, Roche AF, Martorell R. Anthropometric Standardization Reference Manual. Champaign,Illinois: Human Kinetics Books; 1988.'}, {'pmid': '25850095', 'type': 'BACKGROUND', 'citation': 'He H, Kong F, Tan J. DietCam: Multiview Food Recognition Using a Multikernel SVM. IEEE J Biomed Health Inform. 2016 May;20(3):848-855. doi: 10.1109/JBHI.2015.2419251. Epub 2015 Apr 2.'}, {'type': 'BACKGROUND', 'citation': 'Sony Coporation. Smarteyeglass: API Overview. 2017; https://developer.sony.com/develop/wearables/smarteyeglass-sdk/api-overview/. Accessed Feb, 2017.'}, {'pmid': '32517834', 'type': 'DERIVED', 'citation': 'Chui TK, Tan J, Li Y, Raynor HA. Validating an automated image identification process of a passive image-assisted dietary assessment method: proof of concept. Public Health Nutr. 2020 Oct;23(15):2700-2710. doi: 10.1017/S1368980020000816. Epub 2020 Jun 10.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this investigation is to validate a passive image-assisted dietary assessment method using images taken by Sony Smarteyeglass and an automatic image analysis software, DietCam, to identify food items and estimate portion sizes. Participants will be randomized into one of the two orders of meals (Order 1 and 2). In each meal, participants will be given a meal that includes a regular-shaped single food (i.e., cookie), an irregular-shape single food (i.e., ice cream), a regular-shaped mixed food (i.e., sandwich), and irregular-shaped mixed food (i.e., pasta dish).', 'detailedDescription': 'All participants will be asked to come to Healthy Eating and Activity Laboratory for 1, 30-minute screening session, and then for 2, 40-minute meal sessions, with approximately one week occurring between each session. Sessions will be scheduled between 11:00am and 5:00pm, Monday to Friday. During the screening session, interested participants will sign the consent form. After signing the consent from, eligibility will be confirmed by taking height and weight measures. Participants will also be given questionnaires related to demographics. Prior to the start of the first meal session, eligible participants will be randomized to one of the two orders (Order 1 and 2), using a random numbers table. Participants will be instructed for the meal sessions to stop eating a minimum of two hours prior to the scheduled meal sessions and only consume water during that period.\n\nDuring both meal sessions, instructions on how to use Sony Smarteyeglass will be provided to participants. These instructions will include how to wear and use the eyeglasses. Participants will be instructed that, after putting on the Smarteyeglass, to initiate the recording via the controller of the Sony Smarteyeglass. After the recording is initiated and prior to starting to eat, participants will be instructed to look at each provided food at the table. Then, participants will also be instructed to turn their head toward the left shoulder, look at each food from the side, and then repeat the same step for turning their head toward the right shoulder. Participants will be asked to start the meal by taking one bite of each provided food. For the first bite of each food, participants will be instructed to hold the food, either in their hand or on a fork or spoon (depending on the food), approximately 12 inches in front of the eyeglasses and to look at the food. Following taking the first bite of each provided food, participants will be instructed to eat normally until satisfied. Participants will be given 30 minutes to eat. The investigator will leave the room while the participant is eating. The investigator will check in with participants every 10 minutes. At the end of 30 minutes, participants will be instructed to again look at each provided food on the table at three different angles (looking straight at each food, from left side and the right side) following the exact same procedure at the beginning of the meal.\n\nOn the day following each meal session, participants will be called to complete a 24-hour dietary recall, which will take 20 minutes to complete. Instructions will be provided to participants at the end of each meal session about how to complete the dietary recall and a two-dimensional visual aid will be provided to aid participants in estimating the consumed portions for each food and beverage item consumed.\n\nThe second meal session will follow the same procedure as the first session. At the end of second meal session, participants will be asked to complete a questionnaire to provide feedback on their use of the Sony Smarteyeglass.\n\nFor the first and second meal session, the meals will contain foods that are categorized into two food shapes (Regular and Irregular) and two food complexities (Single food and Mixed food). Each meal will contain four foods with the four foods representing the four potential food categories (regular-shaped single food, irregular-shaped single food, regular-shaped mixed food, irregular-shaped mixed food). Along with the four foods, participants will be given 20oz of water in each meal session. Foods will be weighed prior to being provided to participants and the amount provided to participants will be within +/- 3g of the amount calculated. Mixed foods will be broken down into their individual food components and measured. Each meal will provide approximately 50% of daily estimated energy need for each sex. The Estimated Calories Needed Per Day for males and females aged 19 to 35 years are 2450 kcal/day and 1900 kcal/day, respectively. Thus, each meal will provide approximately 1225 kcal for males and 950 kcal for females. Each food will provide approximately 25% of the energy for each meal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* between the ages of 18 and 65 years;\n* body mass index (BMI) 18.5 to 24.9 kg/m2;\n* no food allergies/intolerance to foods used in the investigation;\n* report not having a dietary plan or dietary restrictions that prevents consumption of the foods used in the investigation;\n* report a favorable preference for the foods served in the meal, with participants rate each food item 3 on a Likert scale during the phone screen;\n* able to complete all two meal sessions within four weeks of the screening session;\n* are not legally blind without corrected lenses; and\n* are able to eat a meal while wearing the Sony Smarteyeglass.\n\nExclusion Criteria:\n\n* wear electronic medical devices such as pacemakers and implantable defibrillators'}, 'identificationModule': {'nctId': 'NCT03267004', 'briefTitle': 'Dietary Assessment Study Via Digital Images', 'organization': {'class': 'OTHER', 'fullName': 'The University of Tennessee, Knoxville'}, 'officialTitle': 'Validation Study of a Passive Image-Assisted Dietary Assessment With Automated Image Analysis Process', 'orgStudyIdInfo': {'id': 'UTK IRB-17-03829-XP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Meal Order 1', 'description': 'Meal A will be served to participant in meal session 1 and Meal B in meal session 2.', 'interventionNames': ['Device: Dietary Assessment of Meal A using images taken by Sony Smarteyeglass', 'Device: Dietary Assessment of Meal B using Images taken by Sony Smarteyeglass']}, {'type': 'EXPERIMENTAL', 'label': 'Meal Order 2', 'description': 'Meal B will be served to participant in meal session 1 and Meal A in meal session 2.', 'interventionNames': ['Device: Dietary Assessment of Meal A using images taken by Sony Smarteyeglass', 'Device: Dietary Assessment of Meal B using Images taken by Sony Smarteyeglass']}], 'interventions': [{'name': 'Dietary Assessment of Meal A using images taken by Sony Smarteyeglass', 'type': 'DEVICE', 'description': 'Participant will be wearing Sony Smarteyeglass to record digital images while eating meal A in the laboratory\n\nMeal A:\n\nTurkey and Provolone Cheese Sandwich \\[whole wheat bread 52g(female \\& male), Turkey 70g(female) \\& 133g(male), Provolone cheese 23g(female \\& male), tomato 50g(female \\& male), lettuce 45g(female \\& male)\\]; Chicken and wild rice \\[chicken 98g(female \\& male), wild rice 71g(female) \\& 107g(male)\\]; chocolate chips cookies \\[44g(female) \\& 60.5g(male)\\]; potato chips \\[39g(female) \\& 52g(male)\\].', 'armGroupLabels': ['Meal Order 1', 'Meal Order 2']}, {'name': 'Dietary Assessment of Meal B using Images taken by Sony Smarteyeglass', 'type': 'DEVICE', 'description': 'Participant will be wearing Sony Smarteyeglass to record digital images while eating meal B in the laboratory\n\nMeal B:\n\nHam \\& Cheddar cheese wrap \\[Tortilla 45g(female \\& male), Ham deli 76g(female) \\& 103g(male), cheddar cheese 21g(female) \\& 32g(male), Spring Mix 36g(female \\& male), Fat Free ranch dressing 29g(female \\& male)\\]; Pasta with broccoli and Alfredo sauce \\[Pasta 91g(female) \\& 121g(male), Broccoli 66g(female \\& male), Alfredo sauce 38g(female) \\& 50g(male)\\]; Chocolate Ice-cream \\[107g(female), 138g(male)\\]; Red seedless grapes \\[365g (female), 471g(male)\\].', 'armGroupLabels': ['Meal Order 1', 'Meal Order 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37996', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Healthy Eating and Activity Laboratory, University of Tennessee', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}], 'overallOfficials': [{'name': 'Tsz-Kiu Chui', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Tennessee'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Tennessee, Knoxville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Faculty Advisor', 'investigatorFullName': 'Hollie Raynor', 'investigatorAffiliation': 'The University of Tennessee, Knoxville'}}}}