Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-03-21 @ 6:09 PM
Study NCT ID:
NCT04758559
Status:
COMPLETED
Last Update Posted:
2024-12-06
First Post:
2021-02-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Usability of myfood24 in Clinical Populations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D001836', 'term': 'Body Weight Changes'}], 'ancestors': [{'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised into:\n\nUsual care; myfood24; myfood24 with automated suggestions'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2021-02-09', 'studyFirstSubmitQcDate': '2021-02-12', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Usability of myfood24', 'timeFrame': '6 weeks', 'description': 'System usability scale 1 to 10. HIgher score is better. Online survey.'}], 'secondaryOutcomes': [{'measure': 'Ability of myfood24+ diet optimisation to change diet to meet diet targets', 'timeFrame': '6 weeks', 'description': 'myfood24 app allows the healthcare professional to set personalised nutrition targets for the patient. Nutrient intakes will be measured in myfood24 and myfood24+ diet optimisation groups. We will explore differences in nutrient intakes between the groups. Nutrients measured will be daily intake average for energy (kcal), protein (g), fat (g), carbohydrate (g), fibre (g) sodium (g).'}, {'measure': 'Response rate', 'timeFrame': '6 weeks', 'description': 'response rates prior to undertaking a full scale randomised controlled trial'}, {'measure': 'Correlation between diet and routine measure of body mass index', 'timeFrame': '6 weeks', 'description': 'To explore correlations between mean energy intake (kcal/day) as recorded by multiple online 24-hour dietary recalls, with routine BMI in kg/m\\^2'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diet monitoring', 'diet optimisation', 'nutrition'], 'conditions': ['Gastroenterology Surgery', 'Colorectal Surgery', 'Weight Loss', 'Weight Change, Body']}, 'referencesModule': {'references': [{'pmid': '30089491', 'type': 'RESULT', 'citation': 'Wark PA, Hardie LJ, Frost GS, Alwan NA, Carter M, Elliott P, Ford HE, Hancock N, Morris MA, Mulla UZ, Noorwali EA, Petropoulou K, Murphy D, Potter GDM, Riboli E, Greenwood DC, Cade JE. Validity of an online 24-h recall tool (myfood24) for dietary assessment in population studies: comparison with biomarkers and standard interviews. BMC Med. 2018 Aug 9;16(1):136. doi: 10.1186/s12916-018-1113-8.'}, {'pmid': '26024292', 'type': 'RESULT', 'citation': 'Carter MC, Albar SA, Morris MA, Mulla UZ, Hancock N, Evans CE, Alwan NA, Greenwood DC, Hardie LJ, Frost GS, Wark PA, Cade JE; myfood24 Consortium. Development of a UK Online 24-h Dietary Assessment Tool: myfood24. Nutrients. 2015 May 27;7(6):4016-32. doi: 10.3390/nu7064016.'}], 'seeAlsoLinks': [{'url': 'http://www.myfood24.org/', 'label': 'website of myfood24 tool'}]}, 'descriptionModule': {'briefSummary': "Many patients would benefit from dietary/nutritional support to better manage their conditions but evaluating current intake in relation to personal targets is labour-intensive and often does not feature as part of clinical consultations.\n\nPrimary objective: test usability and acceptability of 'myfood24 Health' for monitoring dietary intake in a group of patients.\n\nRecruit 60 gastroenterology surgery patient (Leeds) and 60 Tier 3 Weight Management patients (30 Leeds/ 30 York).\n\nRandomise to 3 groups\n\n1. usual care\n2. myfood24Health\n3. myfood24Health plus personalised feedback 'diet optimisation engine' which suggests changes to amounts or types of foods\n\nDuring a 2-month follow-up, patients in group 2 or 3 will be asked to record daily diet in myfood24, including weekend and weekdays and use it a minimum of 4 times.\n\nHCPs will be able to review diet/nutrients for group 2 and 3 patients and can support dietary change or nutritional goals, as part of patients' ongoing clinical management, during existing scheduled clinic visits (N.B. not all participants will have a scheduled clinic appointment during the study).\n\n2 months after recruitment, all participants will receive a link to an online feedback questionnaire.\n\nAt end of study, HPCs will be invited to provide feedback during a 30 minute interview.", 'detailedDescription': 'See published results at https://www.mdpi.com/2072-6643/14/9/1768'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to use a smartphone or tablet\n* Have regular access to the internet\n* Aged 18 years or over\n* Not receiving palliative treatment for their condition\n* No pre-existing condition, eg. diabetes which requires a specific diet or eating disorder\n* No food allergies\n* Be receiving ongoing gastrointestinal surgery or weight management treatment\n* Be able to read and understand English\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04758559', 'briefTitle': 'Usability of myfood24 in Clinical Populations', 'organization': {'class': 'OTHER', 'fullName': 'University of Leeds'}, 'officialTitle': 'Usability of myfood24 in Clinical Populations', 'orgStudyIdInfo': {'id': 'IRAS 266347'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Usual care', 'description': 'Patients receive usual care concerning dietary advice.', 'interventionNames': ['Other: usual care']}, {'type': 'EXPERIMENTAL', 'label': 'myfood24', 'description': 'Patients receive myfood24 a new online app to support tracking of food and nutrient intakes, and allows patients and healthcare professionals to communicate, seeing results of intakes to promote healthy dietary behaviour changes.', 'interventionNames': ['Other: myfood24']}, {'type': 'EXPERIMENTAL', 'label': 'myfood24 + diet optimisation', 'description': 'Personalised feedback. Patients use myfood24 with an additional feature of new technology providing guidance of how to optimise their diets against targets, using information they provide about current intakes.', 'interventionNames': ['Other: myfood24']}], 'interventions': [{'name': 'myfood24', 'type': 'OTHER', 'otherNames': ['myfood24 + diet optimisation'], 'description': 'An app to support monitoring of food and nutrient intake using robust validated methodology.', 'armGroupLabels': ['myfood24', 'myfood24 + diet optimisation']}, {'name': 'usual care', 'type': 'OTHER', 'description': 'Patients will receive standard advice as provided by the clinical team, this may or may not include nutrition.', 'armGroupLabels': ['Usual care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leeds', 'state': 'W. Yorks', 'country': 'United Kingdom', 'facility': 'Gastroenterology surgery', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'city': 'York', 'country': 'United Kingdom', 'facility': 'Tier 3 Weight Management Clinic', 'geoPoint': {'lat': 53.95763, 'lon': -1.08271}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Leeds', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dietary Assessment Ltd', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Janet Cade', 'investigatorAffiliation': 'University of Leeds'}}}}