Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-27 @ 11:29 PM
Study NCT ID:
NCT06401694
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-16
First Post:
2024-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating an Enhanced Home-delivered Meal Program on Older Adults' Health and Well-being
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1640}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2024-05-02', 'studyFirstSubmitQcDate': '2024-05-02', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diet Quality', 'timeFrame': '12 weeks', 'description': 'Dietary Screening Tool (DST); Minimum value (0) indicates lowest possible score; Maximum value (100) indicates highest possible score'}], 'secondaryOutcomes': [{'measure': 'Food Security', 'timeFrame': '12 weeks', 'description': 'U.S. Household Food Security Survey Module: Six-Item Short Form; Minimum value (0) indicates high food security; Maximum value (6) indicates very low food security'}, {'measure': 'Nutrition Security', 'timeFrame': '12 weeks', 'description': '2-item Nutrition Security Screener (NSS); participants responding (a) very hard, (b) hard, or (c) somewhat hard to the first question will be designated as nutrition insecure.'}, {'measure': 'Loneliness', 'timeFrame': '12 weeks', 'description': 'University of California, Los Angeles 3-Item Loneliness Scale; Minimum value (3) indicates low feelings of loneliness; Maximum value (9) indicates high feelings of loneliness'}, {'measure': 'Health-Related Quality of Life', 'timeFrame': '12 weeks', 'description': 'The Centers for Disease Control and Prevention\'s Health-Related Quality of Life 4-question core modules, called the "Healthy Days Measures"; The unhealthy days index is calculated by summing the number of physically and mentally unhealthy days, capped at 30 total days.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diet, Healthy', 'Food Insecurity', 'Loneliness', 'Quality of Life']}, 'referencesModule': {'references': [{'pmid': '41034808', 'type': 'DERIVED', 'citation': 'Costa da Silva IL, Gans KM, Thomas KS, Gutman R, Tyler B, Ray S, Grady M, DeFelice S, Hussein M, Lusi A, Caspi CE. A study protocol for a randomized controlled trial evaluating the impact of adding community health worker coaching calls and healthy grocery bag deliveries to a Meals on Wheels home-delivered meal program for homebound older adults in Rhode Island. BMC Public Health. 2025 Oct 1;25(1):3285. doi: 10.1186/s12889-025-24080-6.'}]}, 'descriptionModule': {'briefSummary': 'Meals on Wheels of Rhode Island (MOWRI), in partnership with the University of Connecticut (UConn), will implement and evaluate an enhanced version of its Home-Delivered Meals Program (HDMP). The project goal is to implement and test the effectiveness of an enhanced Home-Delivered Meals (HDM) service delivery approach. The enhanced approach includes community health worker (CHW) interactions and supplemental healthy grocery bags to address diet quality, food and nutrition security, loneliness, and health-related quality of life for older adults. MOWRI participants at the highest nutritional risk will be randomized to receive standard or enhanced services in order to test the effect of the intervention on health-related outcomes. Anticipated outcomes for individuals receiving enhanced services are improvements in measures of diet quality, food and nutrition security, loneliness, and health-related quality of life compared with those receiving standard HDM services.', 'detailedDescription': 'The purpose of the research study is to understand the effectiveness of an enhanced Home-Delivered Meals Program (HDMP) on the health-quality of life for older adults. Specifically, the investigators will study the effectiveness of an enhanced HDMP service delivery approach that includes community health worker interactions and supplemental healthy grocery bags to address diet quality, food and nutrition security, loneliness, and health-related quality of life, compared to HDMP only. The research will take place among individuals receiving meals from Meals on Wheels Rhode Island (MOWRI). This is a pragmatic randomized controlled trial with the following objectives: 1) to develop a protocol for CHW engagement (assessment, intervention, and follow-up) with participants; 2) to implement the enhanced home delivered meals (HDM) intervention to MOWRI clients at the highest nutritional risk; 3) to evaluate the impact of the enhanced program on diet quality, food and nutrition security, loneliness, and HRQOL in a randomized study; 4) to evaluate program sustainability measures and implement process improvements to increase sustainability; 5) to disseminate program resources that will allow the program to replicate to other HDM programs; and 6) to share evaluation results with key community, policy, and academic partners. Up to 1640 participants who are individuals receiving meals from Meals on Wheels Rhode Island (MOWRI) and are at a high nutritional risk. The outcome measures are diet quality (primary outcome), food security, nutrition security, subjective isolation / loneliness, health-related quality of life (HRQOL).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults who are eligible for Title III - funded Meals on Wheels assistance\n* Can read and speak Spanish or English\n* Are nutritionally at risk as determined by the Nutrition Risk Assessment\n* Reside in the state of Rhode Island\n\nExclusion Criteria:\n\n* Cognitive or physical limitations that prevent an individual from giving consent, as assessed by normal interactions by intake staff or study team\n* Cognitive or physical limitations that prevent an individual from participating in intervention or evaluation activities, as assessed by normal interactions intake staff or study team'}, 'identificationModule': {'nctId': 'NCT06401694', 'briefTitle': "Evaluating an Enhanced Home-delivered Meal Program on Older Adults' Health and Well-being", 'organization': {'class': 'OTHER', 'fullName': 'University of Connecticut'}, 'officialTitle': "Evaluating the Impact and Sustainability of Enhanced Home-delivered Meal Program Services on Older Adults' Health and Well-being", 'orgStudyIdInfo': {'id': '24-073-910'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enhanced', 'description': 'Home-delivered meals plus Community Health Worker Calls and supplemental grocery bags', 'interventionNames': ['Other: Home-delivered meals', 'Other: Wellness check and socialization visit', 'Behavioral: Community Health Worker calls', 'Other: Supplemental grocery bag']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care', 'description': 'Home-delivered meals', 'interventionNames': ['Other: Home-delivered meals', 'Other: Wellness check and socialization visit']}], 'interventions': [{'name': 'Home-delivered meals', 'type': 'OTHER', 'description': 'Delivery of prepared meals compliant with Older Americans Act nutrition programs guidelines', 'armGroupLabels': ['Enhanced', 'Usual care']}, {'name': 'Wellness check and socialization visit', 'type': 'OTHER', 'description': 'At-home delivery with opportunity for driver observation and interaction', 'armGroupLabels': ['Enhanced', 'Usual care']}, {'name': 'Community Health Worker calls', 'type': 'BEHAVIORAL', 'description': 'Calls from a certified Community Health Worker (CHW) to assess needs, identify gaps in care and resources, and then support health and resource coordination', 'armGroupLabels': ['Enhanced']}, {'name': 'Supplemental grocery bag', 'type': 'OTHER', 'description': 'Monthly delivery of a grocery bag containing a variety of nutritionally balanced foods and educational materials', 'armGroupLabels': ['Enhanced']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06269', 'city': 'Storrs', 'state': 'Connecticut', 'country': 'United States', 'facility': 'University of Connecticut', 'geoPoint': {'lat': 41.80843, 'lon': -72.24952}}], 'overallOfficials': [{'name': 'Caitlin Caspi, ScD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Connecticut'}, {'name': 'Kim Gans, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Connecticut'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Connecticut', 'class': 'OTHER'}, 'collaborators': [{'name': 'Department of Health and Human Services', 'class': 'FED'}, {'name': 'Meals on Wheels Rhode Island (MOWRI)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Caitlin Caspi', 'investigatorAffiliation': 'University of Connecticut'}}}}