Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-02-23 @ 8:08 PM
Study NCT ID:
NCT03869658
Status:
COMPLETED
Last Update Posted:
2019-09-13
First Post:
2018-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Food Talk: A New App for Daily Food Monitoring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-12', 'studyFirstSubmitDate': '2018-09-19', 'studyFirstSubmitQcDate': '2019-03-08', 'lastUpdatePostDateStruct': {'date': '2019-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Application feasibility', 'timeFrame': 'Betweens days 5 and 7', 'description': 'Feasibility of the use of the application to record dietary intake will be measured through a patient satisfaction questionnaire.'}], 'primaryOutcomes': [{'measure': 'Change in energy intake using food application COCO', 'timeFrame': 'Between days 3 and 7 of the study', 'description': 'The primary outcome will be to assess whether food capture using the mobile application is comparable with conventional 24-hour dietary recall. This will be done by measuring the energy intake (mean of two days) in the two methods.'}, {'measure': 'Change in energy intake using 24 hour dietary recall', 'timeFrame': 'Between days 3 and 7 of the study', 'description': 'The primary outcome will be to assess whether food capture using the mobile application is comparable with conventional 24-hour dietary recall. This will be done by measuring the energy intake (mean of two days) in the two methods.'}], 'secondaryOutcomes': [{'measure': 'Accuracy of food capture method using mobile application', 'timeFrame': 'Between days 3 and 7 of the study', 'description': 'The secondary outcome will measure the energy and nutrient content reported by the mobile application over time. Measured energy intake in a subset of participants in another study that provides dietary intake data will be compared to food intake data using the mobile application.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Voice recognition', '24-hr diet recall', 'Mobile application', 'Self-report'], 'conditions': ['Dietary Intake']}, 'referencesModule': {'references': [{'pmid': '17510091', 'type': 'BACKGROUND', 'citation': 'Wang Y, Beydoun MA. The obesity epidemic in the United States--gender, age, socioeconomic, racial/ethnic, and geographic characteristics: a systematic review and meta-regression analysis. Epidemiol Rev. 2007;29:6-28. doi: 10.1093/epirev/mxm007. Epub 2007 May 17.'}, {'pmid': '24570244', 'type': 'BACKGROUND', 'citation': 'Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.'}, {'pmid': '19635784', 'type': 'BACKGROUND', 'citation': 'Finkelstein EA, Trogdon JG, Cohen JW, Dietz W. Annual medical spending attributable to obesity: payer-and service-specific estimates. Health Aff (Millwood). 2009 Sep-Oct;28(5):w822-31. doi: 10.1377/hlthaff.28.5.w822. Epub 2009 Jul 27.'}]}, 'descriptionModule': {'briefSummary': 'This project will pilot test a new app for self-monitoring food intake using natural spoken language (by voice recognition or text) to provide daily estimates of energy and nutrient intakes with a phone app.', 'detailedDescription': 'Self-recording food intake is recommended for weight management and healthy eating. However, current methods, including web platforms and apps, are often burdensome leading to short-term use by the consumer. The solution uses cutting-edge speech and language understanding technology to streamline the food logging process. With this technology, the user simply describes what they ate and the system automatically selects the appropriate items and quantities consumed from the USDA food database, which calculates the nutrition profile of the entry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Potential subjects will be recruited from the local community around Boston, Massachusetts. Recruitment methods include posting flyers, social and local media advertisements, word of mouth, and emails to HNRCA mailing lists.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Generally healthy men and women 18-65 years if age\n* Currently participating in ongoing studies at the HNRCA\n* Willing and able to sign written informed consent prior to study entry\n* iPhone (iOS 11 or higher) user willing to download the COCO application and record food intake for 5 days\n\nExclusion Criteria:\n\n* Android or iPhone (iOs 10 or lower) user unable to download and use the COCO application\n* Holds a graduate degree in nutrition'}, 'identificationModule': {'nctId': 'NCT03869658', 'briefTitle': 'Food Talk: A New App for Daily Food Monitoring', 'organization': {'class': 'OTHER', 'fullName': 'Tufts University'}, 'officialTitle': 'Food Talk: A New App for Daily Food Monitoring', 'orgStudyIdInfo': {'id': '1234'}}, 'armsInterventionsModule': {'interventions': [{'name': 'COCO application', 'type': 'BEHAVIORAL', 'description': 'All participants will complete a screening survey to determine their eligibility for the study, if eligible and willing to participate, he or she will sign an informed consent form. Once participants are enrolled in the study, a demographics questionnaire will be completed along with 5 days of food tracking on the COCO application. Between days 3 and 7, participants will complete two 24-hr diet recall, one a day, and a patient satisfaction questionnaire.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Human Nutrition Research Center on Aging', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tufts University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Massachusetts Institute of Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Scientist and Lab Director', 'investigatorFullName': 'Susan Roberts', 'investigatorAffiliation': 'Tufts University'}}}}