Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-27 @ 9:01 AM
Study NCT ID:
NCT04906759
Status:
RECRUITING
Last Update Posted:
2024-12-06
First Post:
2021-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Meal Delivery and Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062407', 'term': 'Meals'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-04', 'studyFirstSubmitDate': '2021-05-25', 'studyFirstSubmitQcDate': '2021-05-25', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in gait speed', 'timeFrame': '4 weeks,8 weeks,12 weeks from baseline', 'description': 'this is the time one takes to walk a specified distance on level surfaces over a short distance and is measured in meters/second'}, {'measure': 'Change in total FFP score as assessed by the Fried Frailty Phenotype (FFP) screening test', 'timeFrame': '4 weeks,8 weeks,12 weeks from baseline', 'description': 'Score from 0(not frail),1-2(pre frail) and 3-5(frail)'}, {'measure': 'Change in measure of HSP70 (ng/mL) expression', 'timeFrame': '4 weeks,8 weeks,12 weeks from baseline'}, {'measure': 'Change in Measure of MIP-1β (pg/mL) expression', 'timeFrame': '4 weeks,8 weeks,12 weeks from baseline'}, {'measure': 'Change in Measure of sIL-6R (pg/mL) expression', 'timeFrame': '4 weeks,8 weeks,12 weeks from baseline'}], 'secondaryOutcomes': [{'measure': 'Change in overall frailty status as assessed by the Fried Frailty Phenotype (FFP) screening test', 'timeFrame': '4 weeks,8 weeks,12 weeks from baseline', 'description': 'The FFP defines frailty as having 3 or more characteristics of unintentional weight loss, fatigue, decreased physical activity, weakness, and slowness.Those who have 1 or 2 characteristics are considered pre frail, while those who have no characteristics are robust.'}, {'measure': 'Change in grip strength', 'timeFrame': '4 weeks,8 weeks,12 weeks from baseline', 'description': "Grip strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles .This is measured by using a dynamometer which will be squeezed by the participant 3 times in each hand.The force is measured in kilograms."}, {'measure': 'Change in daily average steps from the activity tracker', 'timeFrame': '4 weeks,8 weeks,12 weeks from baseline'}, {'measure': 'Number of patients that required emergency room visits', 'timeFrame': '6 months post baseline visit'}, {'measure': 'Number of patients that required hospitalization', 'timeFrame': '6 months post baseline visit'}, {'measure': 'Change in activities of daily living as measured by the Katz Index of Independence in Activities of Daily Living', 'timeFrame': '4 weeks,8 weeks,12 weeks from baseline', 'description': 'This consists of 6 questions and each is scored form 0(patient is very dependent)-6(patient is independent)'}, {'measure': 'Change in instrumental activities of daily living as measured by the LAWTON - BRODY INSTRUMENTAL ACTIVITIES OF DAILY LIVING SCALE (I.A.D.L.)', 'timeFrame': '4 weeks,8 weeks,12 weeks from baseline', 'description': 'This consists of 8 questions and each has a summary score range from 0 (low function, dependent) to 8 (high function, independent) for women and 0 through 5 for men to avoid potential gender bias.'}, {'measure': 'Change in loneliness as assessed by the UCLA Loneliness Scale (ULS)', 'timeFrame': '4 weeks,8 weeks,12 weeks from baseline', 'description': 'This questionnaire consists of 20 questions and each is answered from 1(never)-4(always) for a total score ranging form 20-80'}, {'measure': 'Social network as assessed by the LUBBEN SOCIAL NETWORK SCALE - 18 (LSNS-18)', 'timeFrame': '4 weeks,8 weeks,12 weeks from baseline', 'description': 'LSNS-R total score is an equally weighted sum of twelve items. Scores range from 0 to 90, a higher number indicating a better outcome'}, {'measure': 'change in measure of IL-6 (pg/mL) expression', 'timeFrame': '4 weeks,8 weeks,12 weeks from baseline'}, {'measure': 'Change in measures of CRP (ng/mL) expression', 'timeFrame': '4 weeks,8 weeks,12 weeks from baseline'}, {'measure': 'Change in measures of TNF-α (pg/mL) expression', 'timeFrame': '4 weeks,8 weeks,12 weeks from baseline'}, {'measure': 'Change in measures of microbiome (fecal sample) expression', 'timeFrame': '4 weeks,8 weeks,12 weeks from baseline'}, {'measure': 'change in IL-6 (pg/mL) as measured by the frailty status', 'timeFrame': '4 weeks,8 weeks,12 weeks from baseline'}, {'measure': 'change in CRP (ng/mL) as measured by the frailty status', 'timeFrame': '4 weeks,8 weeks,12 weeks from baseline'}, {'measure': 'change in TNF-α (pg/mL) as measured by the frailty status', 'timeFrame': '4 weeks,8 weeks,12 weeks from baseline'}, {'measure': 'change in HSP70 (ng/mL) as measured by the frailty status', 'timeFrame': '4 weeks,8 weeks,12 weeks from baseline'}, {'measure': 'change in MIP-1β (pg/mL) as measured by the frailty status', 'timeFrame': '4 weeks,8 weeks,12 weeks from baseline'}, {'measure': 'change in sIL-6R (pg/mL) as measured by the frailty status', 'timeFrame': '4 weeks,8 weeks,12 weeks from baseline'}, {'measure': 'change in microbiome (fecal sample) as measured by the frailty status', 'timeFrame': '4 weeks,8 weeks,12 weeks from baseline'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['homebound patients', 'exercise', 'nutrition'], 'conditions': ['Frailty']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effects of a home-based exercise program administered through Meals on wheels (MOW) on gait speed and frailty status and to assess the association between novel serum biomarkers (70 kilodalton heat shock proteins (HSP70),Macrophage Inflammatory Proteins(MIP1b), soluble IL-6 receptor alpha-chain (sIL-6R)) and established but non-specific frailty biomarkers (Interleukin 6 (IL-6), C-reactive protein (CRP), Tumor necrosis factor (TNF-α)) in frail and prefrail homebound older adults before and after the exercise intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* homebound (normally unable to leave the home unassisted)\n* frail or prefrail by The Fried Frailty Phenotype (FFP)\n* medically stable\n\nExclusion Criteria:\n\n* robust by FFP\n* have Mini-Cog score \\<3 and/or are unable to follow instructions\n* have a pre-diagnosed terminal illness\n* unable to ambulate\n* unable to use their upper extremities, and/or are already participating in physician-prescribed physical therapy or occupational therapy.'}, 'identificationModule': {'nctId': 'NCT04906759', 'briefTitle': 'Meal Delivery and Exercise', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'A Meal Delivery and Exercise Intervention to Increase Resilience in Homebound Older Adults', 'orgStudyIdInfo': {'id': 'HSC-MS-21-0125'}, 'secondaryIdInfos': [{'id': '1K23AG072042-01', 'link': 'https://reporter.nih.gov/quickSearch/1K23AG072042-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Meals plus exercise', 'interventionNames': ['Behavioral: Meals plus exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Meals only', 'interventionNames': ['Behavioral: Meals only']}], 'interventions': [{'name': 'Meals plus exercise', 'type': 'BEHAVIORAL', 'description': 'Participants will receive 12 weeks of a MOW delivery service that will include 2 meals per day during the weekdays with 4 shelf-stable meals at the end of the week. The MOW driver will visit the participants in-person to ask a series of 5 questions about change in health status, joint/muscle injuries, new pain, falls, and poor appetite twice a week. Participants will also will receive an exercise kit from the MOW driver with their first meal delivery which will contain 2 tennis balls, 2 1-pound hand weights, and one towel. Every week, the driver will give the participants a handout containing 3 exercises from the NIA Go4Life Workout-to-Go book that are designed to help with strength/endurance, balance, and flexibility20. The participants will be asked to do the 3 exercises every day, if possible, on their own. Every 4 weeks during the 12-week study period and at 6 months follow up patients will have blood drawn for frailty and inflammatory biomarkers.', 'armGroupLabels': ['Meals plus exercise']}, {'name': 'Meals only', 'type': 'BEHAVIORAL', 'description': 'Participants will receive 12 weeks of a MOW delivery service that will include 2 meals per day during the weekdays with 4 shelf-stable meals at the end of the week. The MOW driver will visit the participants in-person to ask a series of 5 questions about change in health status, joint/muscle injuries, new pain, falls, and poor appetite twice a week. they will be asked to continue their usual level of activity.Every 4 weeks during the 12-week study period and at 6 months follow up patients will have blood drawn for frailty and inflammatory biomarkers.', 'armGroupLabels': ['Meals only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jessica Lee, MD,MS', 'role': 'CONTACT', 'email': 'Jessica.Lee@uth.tmc.edu', 'phone': '(713) 500-5457'}, {'name': 'Paola Robles Cordova', 'role': 'CONTACT', 'email': 'Paola.RoblesCordova@uth.tmc.edu', 'phone': '(713) 500-7904'}], 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Jessica Lee, MD,MS', 'role': 'CONTACT', 'email': 'Jessica.Lee@uth.tmc.edu', 'phone': '713-500-5457'}, {'name': 'Paola Robles Cordova', 'role': 'CONTACT', 'email': 'Paola.RoblesCordova@uth.tmc.edu', 'phone': '(713) 500-7904'}], 'overallOfficials': [{'name': 'Jessica Lee, MD,MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jessica Lee', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}