Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT03578458
Status:
COMPLETED
Last Update Posted:
2019-04-24
First Post:
2018-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Novel Mobile Application to Assess Dietary Information
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-23', 'studyFirstSubmitDate': '2018-05-24', 'studyFirstSubmitQcDate': '2018-07-03', 'lastUpdatePostDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Energy and nutrient content captured on the mobile application', 'timeFrame': 'Day 1 intakes recorded on application after meals', 'description': 'During each eating occasion to report foods and amounts consumed'}], 'secondaryOutcomes': [{'measure': 'Energy and nutrient content captured on the mobile application by taking photographs of food consumed', 'timeFrame': 'Day 1 intakes photographed on application after meals', 'description': 'During each eating occasion to report foods and amounts consumed'}, {'measure': 'Assess whether food capture using the mobile application is comparable with a conventional 24-hour recall.', 'timeFrame': 'Day 1 intakes will be reviewed by recall method', 'description': 'Use of application for food capture versus 24 hour dietary recall in reporting foods and amounts consumed'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dietary Assessment']}, 'referencesModule': {'references': [{'pmid': '33693732', 'type': 'DERIVED', 'citation': 'Blanchard CM, Chin MK, Gilhooly CH, Barger K, Matuszek G, Miki AJ, Cote RG, Eldridge AL, Green H, Mainardi F, Mehers D, Ronga F, Steullet V, Das SK. Evaluation of PIQNIQ, a Novel Mobile Application for Capturing Dietary Intake. J Nutr. 2021 May 11;151(5):1347-1356. doi: 10.1093/jn/nxab012.'}]}, 'descriptionModule': {'briefSummary': 'The study will assess the accuracy of food capture methods using a novel mobile application. This will be done by comparing the energy and nutrient content of reported foods against those of foods actually consumed (i.e., reported vs actual). Two methods of using the application will be tested:\n\n1. During each eating occasion to report foods and amounts consumed\n2. By taking photographs of every food consumed, using the camera functionality of the mobile application and using the application the following day (according to the availability of the study subjects) to report foods and amounts consumed. This is to be consistent with the concept of a 24-hour dietary recall.\n\nOne group will use a standard 24-hour dietary recall method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Generally healthy men and women 18-65 years of age\n* Eats a wide variety of foods from all food groups\n* 18 ≤ body mass index (BMI) \\< 30 kg/m2\n* Ability to read and write in English\n* iPhone (iOS 11 or higher) or Android phone (6 or higher) user willing to download the mobile application\n\nExclusion Criteria:\n\n* Presence of active disease at screening that would prevent normal dietary intake and/or would result in weight loss (irritable bowel syndrome, Crohn's disease, celiac disease, etc.)\n* Medical complications or chronic illness that would prevent full participation (e.g., active cancer)\n* Pregnant or lactating women\n* Diagnosed eating disorder\n* Vegetarian\n* Special dietary requirements or severe allergies that prevent the consumption of major food groups (e.g., gluten free, lactose free, Halal)\n* Diagnosis of a mental health condition that has not been stable within the past 6 months\n* Current or previous experience with dietary data collection or analysis\n* Concurrent participation in another research study at any point during the study\n* Availability and access to a tablet device (iPad, Android) only\n* Shift workers\n* Plan to partake in vigorous physical training/ exercise during the study period (e.g., training for or running a marathon)"}, 'identificationModule': {'nctId': 'NCT03578458', 'briefTitle': 'Novel Mobile Application to Assess Dietary Information', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Evaluation of a Novel Mobile Application to Assess Dietary Information', 'orgStudyIdInfo': {'id': '17.13.NIHS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'US Healthy diet', 'description': 'Subjects will install a mobile app for use and will be randomly assigned to a healthy diet.', 'interventionNames': ['Other: subjects will install a mobile app for use']}, {'type': 'OTHER', 'label': 'Vegetarian diet', 'description': 'Subjects will install a mobile app for use and will be randomly assigned to a vegetarian diet.', 'interventionNames': ['Other: subjects will install a mobile app for use']}, {'type': 'OTHER', 'label': 'Mediterranean diet', 'description': 'Subjects will install a mobile app for use and will be randomly assigned to a Mediterranean diet.', 'interventionNames': ['Other: subjects will install a mobile app for use']}], 'interventions': [{'name': 'subjects will install a mobile app for use', 'type': 'OTHER', 'description': 'novel mobile application', 'armGroupLabels': ['Mediterranean diet', 'US Healthy diet', 'Vegetarian diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts University USDA Human Nutrition Research Center on Aging (HNRCA)', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Sai Krupa Das, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tufts University USDA Human Nutrition Research Center on Aging (HNRCA), Boston MA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}