Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-27 @ 9:59 PM
Study NCT ID:
NCT06061861
Status:
RECRUITING
Last Update Posted:
2024-03-19
First Post:
2023-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Kaiser Permanente Evaluating Nutritional Interventions in Food-Insecure High-Risk Adults Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005378', 'term': 'Financial Support'}], 'ancestors': [{'id': 'D004467', 'term': 'Economics'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-18', 'studyFirstSubmitDate': '2023-09-12', 'studyFirstSubmitQcDate': '2023-09-25', 'lastUpdatePostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6-month change in glycosylated hemoglobin level', 'timeFrame': '6 months after enrollment', 'description': 'Baseline glycosylated hemoglobin will be ascertained using routine laboratory tests in the electronic health record prior to enrollment. Participants will complete glycosylated hemoglobin testing 6 months after enrollment.'}], 'secondaryOutcomes': [{'measure': '12-month change in glycosylated hemoglobin level', 'timeFrame': '12 months after enrollment', 'description': 'Glycosylated hemoglobin will be ascertained using routine laboratory tests in the electronic health record at 12 months after enrollment.'}, {'measure': 'Percentage of participants with glycosylated hemoglobin <7.5%', 'timeFrame': '6- and 12-months after enrollment', 'description': 'Baseline glycosylated hemoglobin will be ascertained using routine laboratory tests in the electronic health record prior to enrollment. Participants will complete glycosylated hemoglobin tests 6 months after enrollment. 12-month glycosylated hemoglobin level will be ascertained using routine laboratory tests in the electronic health record.'}, {'measure': 'All-cause hospitalizations or emergency department visits', 'timeFrame': '3-, 6-, and 12-months after enrollment', 'description': 'Occurrence of hospitalization or emergency department visit for any reason within 12 months after enrollment.'}, {'measure': 'Change in self-reported level of food security', 'timeFrame': '6- and 12-months after enrollment', 'description': 'Participants will answer 10 questions about their food security using the USDA adult food security module. Affirmative responses to questions will be assigned 1 point in the food security scale (out of 10). Participants will be classified as being food secure (0-2 points) or food insecure (3-10 points).'}, {'measure': 'Change in self-reported level of nutrition security', 'timeFrame': '6- and 12-months after enrollment', 'description': 'Participants will be asked about their level of difficulty in accessing healthy food on a 5-point Likert scale. Participants will also be asked 13 questions on reasons for not eating healthy food, with each question scored from 0-2 (Never, Sometimes, Often true). Lower scores indicate higher nutrition security.'}, {'measure': 'Change in self-reported dietary habits', 'timeFrame': '6- and 12-months after enrollment', 'description': 'Participants will be asked 8 questions to examine their consumption of fast food, fruits, vegetables, legumes, nuts, dairy, seafood, sweets, and sugar-sweetened beverages over the past month.'}, {'measure': 'Change in self-reported diabetes-related quality of life', 'timeFrame': '6- and 12-months after enrollment', 'description': 'Participants will answer 13 questions about their diabetes-related quality of life, each on a 5-point Likert scale. Scores range from 13-65, with higher scores indicating lower diabetes-related quality of life.'}, {'measure': 'Change in self-reported readiness to change', 'timeFrame': '6- and 12-months after enrollment', 'description': 'Participants will be asked about their readiness to change their dietary habits to manage their diabetes on a 5-point Likert scale.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The goal of this randomized controlled trial is to compare the effect of receiving 6 months of monetary support for healthy food through a food delivery platform on change in glycosylated hemoglobin (HbA1c) levels among adults with type 2 diabetes mellitus with glycemic control that is above target level.\n\nThe main study aims are to:\n\n1. To evaluate whether providing monthly financial support for home-delivered healthy food vs. only free food delivery through the Instacart platform reduces glycosylated hemoglobin levels within 6 months among Medi-Cal-insured Kaiser Permanente adult members with diabetes mellitus and suboptimal glycemic control.\n2. To evaluate whether providing monthly financial support for home-delivered healthy food vs. only free food delivery through the Instacart platform reduces medical resource utilization within 6 months among Medi-Cal-insured Kaiser Permanente adult members with diabetes mellitus and suboptimal glycemic control.', 'detailedDescription': 'Eligible Kaiser Permanente adult members will be randomized to one of two groups:\n\n1. Intervention arm, in which subjects will receive 6 months of monetary support (with up to 4 free home deliveries and no service fees) through the Instacart platform to select and receive healthy foods (e.g., vegetables and fruit).\n2. Control arm, in which subjects will receive 6 months of free home deliveries and no service fees for up to 4 deliveries each month through the Instacart platform.\n\nGlycosylated hemoglobin level will be assessed at baseline and at 6 months after enrollment. Medical resource utilization will be evaluated at 3 months, 6 months, and 12 months after enrollment. Patient-reported outcomes (i.e., diabetes quality of life, nutrition security, dietary habits, social needs, and food security) will also be assessed at baseline, 6 months, and 12 months after enrollment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged ≥18 years old at enrollment\n* Active membership in Kaiser Permanente with Medi-Cal insurance and no additional private or commercial insurance\n* Diagnosis of Type II diabetes mellitus (not including Type I diabetes mellitus or gestational diabetes mellitus)\n* At least 2 outpatient glycosylated hemoglobin measures ≥7.5% in the prior 18 months\n* Current access to the internet via computer or mobile device\n* No interpreter needed\n\nExclusion Criteria:\n\n* Advanced or end-stage kidney disease (estimated glomerular filtration rate ≤15 ml/min/1.73m\\^2 or receiving outpatient dialysis or having a prior kidney transplant)\n* Known pregnancy at time of identification'}, 'identificationModule': {'nctId': 'NCT06061861', 'acronym': 'KP ENRICH', 'briefTitle': 'Kaiser Permanente Evaluating Nutritional Interventions in Food-Insecure High-Risk Adults Study', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'Kaiser Permanente Evaluating Nutritional Interventions in Food-Insecure High-Risk Adults (KP ENRICH) Study', 'orgStudyIdInfo': {'id': '2112426'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Financial Support and Free Delivery', 'description': 'The intervention group will receive monthly financial support for healthy food items along with free home delivery through the Instacart platform.', 'interventionNames': ['Other: Financial support for healthy foods and free home delivery']}, {'type': 'EXPERIMENTAL', 'label': 'Free Delivery', 'description': 'The control group will receive only free home delivery through the Instacart platform.', 'interventionNames': ['Other: Free home delivery']}], 'interventions': [{'name': 'Financial support for healthy foods and free home delivery', 'type': 'OTHER', 'description': 'Participants will receive monetary support to spend on healthy food items (e.g., vegetables and fruit) through the Instacart platform for a duration of 6 months and have home delivery and service fees waived for 4 orders per month through the Instacart platform for a duration of 6 months.', 'armGroupLabels': ['Financial Support and Free Delivery']}, {'name': 'Free home delivery', 'type': 'OTHER', 'description': 'Participants will have home delivery and service fees waived for 4 orders per month through the Instacart platform for a duration of 6 months.', 'armGroupLabels': ['Free Delivery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91101', 'city': 'Pasadena', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Claudia Nau, PhD', 'role': 'CONTACT', 'email': 'claudia.l.nau@kp.org', 'phone': '626-564-5760'}], 'facility': 'Kaiser Permanente Southern California Department of Research & Evaluation', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '94588', 'city': 'Pleasanton', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Richard Grant, MD', 'role': 'CONTACT', 'phone': '510-821-3969'}], 'facility': 'Kaiser Permanente Northern California Division of Research', 'geoPoint': {'lat': 37.66243, 'lon': -121.87468}}], 'centralContacts': [{'name': 'Thida C Tan, MPH', 'role': 'CONTACT', 'email': 'thida.x.tan@kp.org', 'phone': '510-891-5982'}], 'overallOfficials': [{'name': 'Claudia L Nau, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaiser Permanente'}, {'name': 'Richard Grant, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaiser Permanente'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}