Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-28 @ 10:20 PM
Study NCT ID:
NCT03995303
Status:
COMPLETED
Last Update Posted:
2021-11-17
First Post:
2019-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HOMEFOOD Study - Home Delivered Food and Nutrition Therapy for Discharged Geriatric Hospital Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-16', 'studyFirstSubmitDate': '2019-01-09', 'studyFirstSubmitQcDate': '2019-06-21', 'lastUpdatePostDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body weight', 'timeFrame': 'Measurement at discharge, baseline', 'description': 'Body weight in kilograms'}, {'measure': 'Body weight', 'timeFrame': 'Measurement at 12 weeks', 'description': 'Body weight in kilograms'}, {'measure': 'Body weight', 'timeFrame': 'Measurement at 24 weeks', 'description': 'Body weight in kilograms'}, {'measure': 'Five Times Sit to Stand Test', 'timeFrame': 'Measurement at discharge, baseline', 'description': 'Part of short physical performance battery, yes vs no'}, {'measure': 'Five Times Sit to Stand Test', 'timeFrame': 'Measurement at 12 weeks', 'description': 'Part of short physical performance battery, yes vs no'}, {'measure': 'Five Times Sit to Stand Test', 'timeFrame': 'Measurement at 24 weeks', 'description': 'Part of short physical performance battery, yes vs no'}, {'measure': 'Balance test', 'timeFrame': 'Measurement at discharge, baseline', 'description': 'Part of short physical performance battery, yes vs no'}, {'measure': 'Balance test', 'timeFrame': 'Measurement at 12 weeks', 'description': 'Part of short physical performance battery, yes vs no'}, {'measure': 'Balance test', 'timeFrame': 'Measurement at 24 weeks', 'description': 'Part of short physical performance battery, yes vs no'}, {'measure': 'Energy intake', 'timeFrame': 'Measurement at discharge, baseline', 'description': 'Energy in kilocalories per 24 hours'}, {'measure': 'Energy intake', 'timeFrame': 'Measurement at 12 weeks', 'description': 'Energy in kilocalories per 24 hours'}, {'measure': 'Energy intake', 'timeFrame': 'Measurement at 24 weeks', 'description': 'Energy in kilocalories per 24 hours'}, {'measure': 'Protein intake', 'timeFrame': 'Measurement at 12 weeks', 'description': 'Protein intake in g/day'}, {'measure': 'Protein intake', 'timeFrame': 'Measurement at discharge, baseline', 'description': 'Protein intake in g/day'}, {'measure': 'Protein intake', 'timeFrame': 'Measurement at 24 weeks', 'description': 'Protein intake in g/day'}, {'measure': 'Fluid intake', 'timeFrame': 'Measurement at discharge, baseline', 'description': 'Fluid intake evaluated'}, {'measure': 'Fluid intake', 'timeFrame': 'Measurement at 12 weeks', 'description': 'Fluid intake evaluated'}, {'measure': 'Fluid intake', 'timeFrame': 'Measurement at 24 weeks', 'description': 'Fluid intake evaluated'}, {'measure': 'Upper arm circumference', 'timeFrame': 'Measurement at discharge, baseline', 'description': 'Measured in centimeters'}, {'measure': 'Upper arm circumference', 'timeFrame': 'Measurement at 24 weeks', 'description': 'Measured in centimeters'}, {'measure': 'Waist circumference', 'timeFrame': 'Measurement at discharge, baseline', 'description': 'Measured in centimeters'}, {'measure': 'Waist circumference', 'timeFrame': 'Measurement at 24 weeks', 'description': 'Measured in centimeters'}, {'measure': 'calf circumference', 'timeFrame': 'Measurement at discharge, baseline', 'description': 'Measured in centimeters'}, {'measure': 'calf circumference', 'timeFrame': 'Measurement at 24 weeks', 'description': 'Measured in centimeters'}, {'measure': 'lean body mass', 'timeFrame': 'Measurement at discharge, baseline', 'description': 'Measured with BIA (kg)'}, {'measure': 'lean body mass', 'timeFrame': 'Measurement at 24 weeks', 'description': 'Measured with BIA (kg)'}, {'measure': 'Grip strength', 'timeFrame': 'Measurement at discharge, baseline', 'description': 'Measured in kg'}, {'measure': 'Grip strength', 'timeFrame': 'Measurement at 12 weeks', 'description': 'Measured in kg'}, {'measure': 'Grip strength', 'timeFrame': 'Measurement at 24 weeks', 'description': 'Measured in lbs'}, {'measure': 'Health Related Quality of Life (HRQL)', 'timeFrame': 'Measurement at discharge, baseline', 'description': 'EQ-5D including SRH'}, {'measure': 'Health Related Quality of Life (HRQL)', 'timeFrame': 'Measurement at 12 weeks', 'description': 'EQ-5D including SRH'}, {'measure': 'Health Related Quality of Life (HRQL)', 'timeFrame': 'Measurement at 24 weeks', 'description': 'EQ-5D including SRH'}, {'measure': 'Depression', 'timeFrame': 'Measurement at discharge, baseline', 'description': 'Center for Epidemiologic Studies Depression scale'}, {'measure': 'Depression', 'timeFrame': 'Measurement at 24 weeks', 'description': 'Center for Epidemiologic Studies Depression scale'}, {'measure': 'Cognitive function', 'timeFrame': 'Measurement at discharge, baseline', 'description': 'MMSE'}, {'measure': 'Cognitive function', 'timeFrame': 'Measurement at 24 weeks', 'description': 'MMSE'}, {'measure': 'Nutrition status', 'timeFrame': 'Measurement at discharge, baseline.', 'description': 'Icelandic Nutrition Screening Tool (score)'}, {'measure': 'Nutrition status', 'timeFrame': 'Measurement at 24 weeks', 'description': 'Icelandic Nutrition Screening Tool (score)'}], 'secondaryOutcomes': [{'measure': 'Re-hospitalization', 'timeFrame': 'at 12 months from recruitment to trial', 'description': 'Number of participants who were re-hospitalized'}, {'measure': 'Mortality', 'timeFrame': 'at 12 months from recruitment to trial', 'description': 'Number of participants who deceased'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Malnutrition', 'Old adults', 'Home-delivered meals', 'NCP - Nutrition Care Process', 'Food'], 'conditions': ['Malnutrition']}, 'referencesModule': {'references': [{'pmid': '39151910', 'type': 'DERIVED', 'citation': 'Eymundsdottir H, Blondal BS, Geirsdottir OG, Ramel A. Poor Activities of Daily Living Predict Future Weight Loss in Older Adults After Hospital Discharge-Secondary Analysis of a Randomized Trial. J Aging Phys Act. 2024 Aug 16;33(1):42-50. doi: 10.1123/japa.2023-0104. Print 2025 Feb 1.'}, {'pmid': '36028775', 'type': 'DERIVED', 'citation': 'Blondal BS, Geirsdottir OG, Beck AM, Halldorsson TI, Jonsson PV, Sveinsdottir K, Ramel A. HOMEFOOD randomized trial-beneficial effects of 6-month nutrition therapy on body weight and physical function in older adults at risk for malnutrition after hospital discharge. Eur J Clin Nutr. 2023 Jan;77(1):45-54. doi: 10.1038/s41430-022-01195-2. Epub 2022 Aug 26.'}]}, 'descriptionModule': {'briefSummary': 'Because of short hospital stays, and nutritional status worsening for geriatric patients, time to improve this is limited. It seems necessary to integrate nutritional support after discharge, to prevent the consequences of malnutrition on health and physical capability. This study tests whether nutrition support using NCP (Nutrition Care Process) (1) in combination with delivered meals designed for old adults, improves nutritional status, muscle strength, physical function, quality of life and rehospitalization and mortality rates after discharge, compared to currently used care (2 = control) along with historical data. Participants (N = 200), will be randomized into two groups, the intervention will last 24 weeks. A dietitian (Ph.D. student) visits participants in the intervention group 5 times during the study period. Outcome parameters will be measured before discharge from the hospital, at 12 weeks and at 24 weeks. Data on hospital readmission and mortality will be followed up at 6 months after the intervention.\n\nCondition or disease: Malnutrition Intervention/treatment: NCP by a dietitian and free food constructed to fulfill protein and energy needs for the group.', 'detailedDescription': "Malnutrition is common in older people admitted to the hospital and can worsen after discharge. Therefore, it seems necessary to integrate nutritional support not only during the hospital stay but also in the period after discharge. The aim of this Randomized Controlled Trial (RCT) is to test whether nutritional support provided by a dietitian, using Nutrition Care Process in combination with delivered meals designed for the needs of older adults (group 1), improves nutritional status, muscle strength, physical function, quality of life and as a secondary outcome re-hospitalization and/or mortality of geriatric patients with malnutrition risk after discharge compared to currently used standard care (group 2 = control).\n\nTime and work plan:\n\nAfter 12 months\n\n* Need identification and product ideas ready\n* Packaging material ready\n* Estimate of the feasibility of meals for old adults\n* Allowances from the ethical committee, the data protection committee, the Ph.D. committee of the Faculty of Food Science and Nutrition at the University of Iceland.\n\nAfter 24 months\n\n* The last participant recruited\n* End of intervention\n\nAfter 36 months\n\n* End of follow up\n* Database ready\n* First paper submitted\n\nMethods-Intervention\n\nThis 24-week randomized controlled trial will randomize the participants (N = 200) to two groups. The dietitian (Ph.D. student) will perform a total of 5 home visits during the study period to participants in the intervention group. Meals will be delivered weekly to the participants. Outcome parameters will be measured just before discharge from the hospital and after 12 weeks and at 24 weeks in the home of the participants. Data on hospital re-admission and mortality will also be followed up at 12 months.\n\nThe aim of the intervention is to implement individual dietetic advice and optimize participants' nutritional status by following the Nutritional Care Process\\*, involving nutritional assessment, diagnosis, intervention, monitoring, and evaluation. Dietary counseling, motivation, and education will help to maintain participants' body weight, and ensure that energy and protein requirements as well as for other critical nutrients are achieved.\n\n\\*The Nutrition Care Process (NCP) reflects the current state of the art in nutrition care and is designed to improve the consistency and quality of individualized care for patients and the predictability of the patient outcomes. It is not intended to standardize nutrition care for each patient, but to establish a standardized process for providing care.\n\nTo achieve the aim, the dietitian (Ph.D. student) will meet the participants in the intervention group, six times.\n\n* The day before discharge where baseline measurements will be done,\n* 1 week after discharge,\n* 3 weeks after discharge,\n* 6 weeks after discharge,\n* 9 weeks after discharge, and\n* 12 weeks after discharge where endpoint measurements will be done. The dietitian (Ph.D. student) will perform an individual nutritional assessment focusing on dietary intake, activity level and weight of each participant, as a basis for developing an individualized nutrition care plan consistent with estimated nutritional requirements and nutritional rehabilitation goals. Total fluid, energy- and protein requirements will be estimated for each patient. To assess dietary intake, the dietitian will perform a dietary history interview at each visit to determine fluid, energy and protein intake of the participant. Strategies for achieving fluid, energy and protein requirements and achieving compliance included dietary counseling with attention to nutritional risk factors, timing, size and frequency of meals, recommendations for nutrient dense foods and drinks, and provision of educational material.\n\nIf relevant, the dietitian will:\n\n* initiate the prescription of oral nutritional supplements with high energy and protein density that will be reimbursed by Health Insurance.\n* Contact providers of meals-on-wheels to change the meals to high energy and protein dense menu or to mashed/puréed food.\n* Recommend use of vitamin D, calcium and other vitamins-minerals considered necessary to achieve optimal nutritional status,\n* Invite home care and community nursing staff to participate in home visits to achieve the best possible outcome for the patient by interdisciplinary collaboration.\n\nIf considered relevant the participants will receive a short consultation by telephone by the dietitian to give advice and to stimulate compliance to the proposed nutritional care plan in-between the home visits.\n\nThe control group will meet the dietitian/staff for baseline, 12 weeks and at the 24-week endpoint measurements. The control group will not receive any dietary counseling or education during the study period which reflects current clinical practice.\n\nThe Ph.D. students' contributions A Ph.D. student in clinical nutrition (Berglind Soffía Blondal) will be the project manager of the intervention study on a day-to-day base. The student will be supervised by Prof. Alfons Ramel and Assoc. Prof. Ólöf Guðný Geirsdóttir, both on the Faculty of Food Science and Nutrition. The student will be involved in application work to the ethical committee, screening, conduct of the intervention study, data work and writing of scientific papers.\n\nEthics The study has been approved by the Ethics Committee of Landspitali- University Hospital of Iceland and informed written consent will be obtained from all participants. The study can only improve the nutritional status of geriatric patients that take part in the intervention groups. The participants in the control group, however, won't get any nutritional interventions and therefore have a greater risk of re-admissions and a worse overall outcome compared to the intervention groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of the geriatric units at the University Hospital of Iceland discharging home to independent living\n* A score of 20 or above on the Mini-Mental State Evaluation (MMSE) form\n* Being at nutritional risk according to the validated nutritional risk screening tool (NRS-2002, score 3+)\n* The capability of eating orally\n\nExclusion Criteria:\n\n* Living at a nursing home\n* MMSE score of under 20\n* No nutritional risk'}, 'identificationModule': {'nctId': 'NCT03995303', 'acronym': 'HOMEFOOD', 'briefTitle': 'HOMEFOOD Study - Home Delivered Food and Nutrition Therapy for Discharged Geriatric Hospital Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Iceland'}, 'officialTitle': 'HOMEFOOD Study - Home Delivered Food and Nutrition Therapy for Discharged Geriatric Hospital Patients', 'orgStudyIdInfo': {'id': 'UI-2018-HOMEFOOD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'NCP and home-delivered meals', 'description': 'Preventing malnutrition with NCP by a registered dietician and home-delivered meals', 'interventionNames': ['Other: NCP and home-delivered meals']}, {'type': 'NO_INTERVENTION', 'label': 'Current practice', 'description': 'Current practice after discharge from the University Hospital of Iceland.'}], 'interventions': [{'name': 'NCP and home-delivered meals', 'type': 'OTHER', 'otherNames': ['NCP and delivered meals'], 'description': 'The dietitian (Ph.D. student) will perform an individual nutritional assessment focusing on dietary intake, activity level and weight of each participant, as a basis for developing an individualized nutrition care plan consistent with estimated nutritional requirements and nutritional rehabilitation goals. Total fluid, energy- and protein requirements will be estimated for each patient. Giving the group free food to fulfill protein-and energy needs.', 'armGroupLabels': ['NCP and home-delivered meals']}]}, 'contactsLocationsModule': {'locations': [{'zip': '101', 'city': 'Reykjavik', 'state': 'Non-US', 'country': 'Iceland', 'facility': 'Geriatric Unit of Landspitali - University Hospital of Iceland', 'geoPoint': {'lat': 64.13548, 'lon': -21.89541}}], 'overallOfficials': [{'name': 'Alfons Ramel, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iceland'}, {'name': 'Olof G Geirsdottir, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iceland'}, {'name': 'Berglind S Blondal, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iceland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Iceland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Alfons Ramel', 'investigatorAffiliation': 'University of Iceland'}}}}