Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:18 AM
Study NCT ID:
NCT07469995
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-16
First Post:
2026-03-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Grocery Support Dose on Food Insecurity and Disease Control Among Covered California Members With Diabetes or Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D002908', 'term': 'Chronic Disease'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized into either intervention arm ($80 vs. $120) at a 3:1 ratio. They will be stratified by preferred language (English vs. non-English) and Covered California metal tier (Silver vs. Bronze). The intervention consists of an $80 or $120 monthly grocery support program provided in the form of a reloadable cash card usable at food retailers including those that sell non-food items.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4450}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-12', 'studyFirstSubmitDate': '2026-03-10', 'studyFirstSubmitQcDate': '2026-03-10', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Low food security', 'timeFrame': 'Baseline, 12 months', 'description': 'Measured as the change in the proportion of participants with low food security. Low food security will be defined as one or more item answered with "Often true" in the Hunger Vital Sign. Change in proportion of participants with low food security, from baseline to 12 months.'}, {'measure': 'Nutrition security', 'timeFrame': 'Baseline, 12 months', 'description': 'Measured using the 14-response options providing reasons why respondents have difficulty eating or not eating healthy foods.'}, {'measure': 'Self-reported utilization', 'timeFrame': 'Baseline, 12 months', 'description': 'Measured based on the change in self-reported hospitalizations, doctors visits, and ED visits within the past 12 months measured as continuous outcome between 0 and 100 or more.'}, {'measure': 'Other social risks', 'timeFrame': 'Baseline, 12 months', 'description': 'Measured using the change in severity or presence of other social risks assessed using validated survey items for housing insecurity, transportation barriers, and financial strain.'}, {'measure': 'Trade-offs', 'timeFrame': 'Baseline, 12 months', 'description': 'Measured using the proportion of participants who report sometimes or often making trade offs between paying for food and paying for medications or medical care, utilities, rent or mortgage, transportation, and education.'}, {'measure': 'Self-rated health', 'timeFrame': 'Baseline, 12 months', 'description': 'Measured using the validated 10-item measure (PROMIS-10) to assess self-rated health, quality of life, mental and physical health, social satisfaction, ability to carry out roles, ability to carry out everyday physical activities, experiences of fatigue, frequency of emotional problems, and average pain. Analysis will assess change in overall measure by study arm.'}, {'measure': 'Perceived stress', 'timeFrame': 'Baseline, 12 months', 'description': 'Measured using changes in self-report based on a validated, 10-item perceived stress scale.'}, {'measure': 'Self-efficacy', 'timeFrame': 'Baseline, 12 months', 'description': 'Measured using changes in participant responses across the 9-item validated self-efficacy scale.'}, {'measure': 'Chronic disease self-efficacy', 'timeFrame': 'Baseline, 12 months', 'description': 'Measured using changes in participant responses across the validated, two-item chronic disease self-efficacy scale.'}, {'measure': 'Utilization characteristics', 'timeFrame': '2 years before study start until 12 months after.', 'description': 'Measured using claims data to analyze utilization characteristics e.g., length of stay (total days, average number of days per stay), days until next admit, and total cost of admissions across the 12 month study period.'}], 'primaryOutcomes': [{'measure': 'Food insecurity status', 'timeFrame': 'Baseline, 12 months', 'description': 'Measured by 2-item Hunger Vital Sign, a validated tool to assess food insecurity. Higher scores indicate greater food insecurity.'}, {'measure': 'Change in HbA1c', 'timeFrame': 'Baseline, 12 months', 'description': 'Change in self-reported HbA1c from baseline by study arm.'}, {'measure': 'Change in frequency of experiences of hypoglycemia', 'timeFrame': 'Baseline, 12 months', 'description': 'Measured using the change in self-reported frequency per week that a participant experiences hypoglycemia.'}, {'measure': 'Change in blood pressure', 'timeFrame': 'Baseline, 12 months', 'description': 'Change in self-reported systolic and diastolic blood pressure from baseline by study arm.'}, {'measure': 'Change in diabetes and/or hypertension distress', 'timeFrame': 'Baseline, 12 months', 'description': 'The change is measured using an adapted 10-item version of the validated 17-item Diabetes and Hypertension Distress Scale, where each item ranges from 1-5, mean score ranges from 1-5, and total score is 10-50 with higher scores indicating greater diabetes- and hypertension-related distress.'}], 'secondaryOutcomes': [{'measure': 'Nutrition security', 'timeFrame': 'Baseline, 12 months', 'description': 'Measured using the one-item response allowing calculation of the proportion of participants that report difficulty getting and eating healthy foods.'}, {'measure': 'Diet quality', 'timeFrame': 'Baseline, 12 months', 'description': 'Measured using the self-reported number of servings of vegetables or number of days where higher fat foods were consumed during the past 7 days, by study arm.'}, {'measure': 'Acute health care utilization', 'timeFrame': '2 years before study start until 12 months after', 'description': 'Proportion of participants that used the ED or had a treat and release ED or observation room visit and number of visits by study arm.'}, {'measure': 'Hospital admissions', 'timeFrame': '2 years before study start until 12 months after', 'description': 'Proportion of participants who were hospitalized at least once and count of total hospitalizations from baseline to 12 months by study arm.'}, {'measure': 'Hospital readmissions', 'timeFrame': '2 years before study start until 13 months after', 'description': 'Proportion of participants who were re-hospitalized within 30-days of the index hospitalization by study arm.'}, {'measure': 'Outpatient visits', 'timeFrame': '2 years before study start until 12 months after', 'description': 'Number of primary care provider, specialist, mental health, and addiction medicine visits across the 12 month study period by study arm.'}, {'measure': 'Self-rated physical and mental health', 'timeFrame': 'Baseline, 12 months', 'description': 'Measured as the change in self-rated overall, physical, and mental health reported on a 0 to 5-response (excellent to poor) scale by study arm. Higher score corresponds to better self-rated health.'}, {'measure': 'Self-reported medication adherence', 'timeFrame': 'Baseline, 12 months', 'description': 'Measured as an affirmative response to cost-based medication nonadherence and the change in a single-item question asking patients how many days (out of 7) they missed taking one of their medications. Changes in the number of days reported from baseline by study arm.'}, {'measure': 'Medication adherence', 'timeFrame': '2 years before study start until 12 months after', 'description': 'Measured using medical claims data and calculated based on daily supply.'}, {'measure': 'Medication count', 'timeFrame': '2 years before study start until 12 months after', 'description': 'Measured using the survey and medical claims as the total number of medications that the participant had at baseline and across the 12-month study period.'}, {'measure': 'Cost-based changes to primary care or medication use', 'timeFrame': 'Baseline, 12 months', 'description': 'Measured using a 5-response question (never to often) to delays to medical care because of cost and a binary (yes/no) response to a question about cost-related medication nonadherence.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Health Insurance Exchange', 'Grocery Support Program', 'Food Insecurity', 'Chronic Disease'], 'conditions': ['Diabetes', 'Hypertension', 'Food Insecurity', 'Low-Income Population', 'Insurance Coverage']}, 'descriptionModule': {'briefSummary': "This continuation study is a pragmatic randomized controlled trial (RCT) of Covered California's Grocery Support Program among low-income participants with diabetes or hypertension. This pragmatic RCT will compare the efficacy of providing different benefit amounts ($80 vs. $120) via a monthly food card benefit for households where at least one adult has diabetes and/or hypertension and incomes below 250% of the federal poverty level (FPL).", 'detailedDescription': 'In 2024, Covered California initiated multiple Population Health Investments (PopHIs) based on funds collected by participating plans if they failed to meet a set of quality benchmarks related to diabetes control, blood pressure control, colorectal cancer screening, and childhood immunizations. One priority area for the PopHIs was food insecurity among patients who manage diabetes and/or hypertension. Food insecurity, defined by the US Department of Agriculture (USDA) as a "lack of access to enough food for an active, healthy life" effects 18% of newly enrolled Covered California members. Food insecurity is more pronounced and is associated with poor clinical outcomes and more avoidable and costly healthcare utilization among individuals who manage diabetes and/or hypertension. In 2025, Covered California initiated the first year of the food insecurity PopHI comparing the impact of an $80 monthly grocery support cash card for 12-months versus a one-time payment at the end of 12-months among a low-income cohort with food insecurity and a chronic condition. Building off year one learnings, Covered California tailored their program design and benefit amount based on findings. While produce prescription and grocery support programs have been shown to reduce food insecurity and improve diet quality, key implementation questions most importantly the impact of varying doses, remain to be understood. The goal of the proposed research is to evaluate the impact of two different doses of a 12-month grocery support program on participant food insecurity and health outcomes among a cohort of individuals with diabetes and/or hypertension. Participants were invited to enroll in the program if they were active members of Covered California at the time of enrollment and had a documented diabetes and/or hypertension diagnosis and an income at or below 250% of the FPL. Participants were randomly assigned to receive either an $80 or $120 reusable semi-restricted cash card re-loaded monthly for one year (payments in both arms adjusted based on household size). Retailers are restricted to food retailers, which includes retailers that do sell non-food goods. The study has four main data sources: survey data from surveys repeated at baseline and 12-months; cash card spending data; qualitative participant interview data, and administrative claims data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Active Covered California member\n* Adult \\>= 18 years of age\n* Has a diabetes and or hypertension diagnosis identifiable in Covered California's administrative claims\n* Income \\<250% FPL\n\nExclusion Criteria:\n\n* No longer a Covered California member\n* $0 spending in year 1 grocery support program"}, 'identificationModule': {'nctId': 'NCT07469995', 'briefTitle': 'The Effect of Grocery Support Dose on Food Insecurity and Disease Control Among Covered California Members With Diabetes or Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'The Effect of Grocery Support Dose on Food Insecurity and Disease Control Among Covered California Members With Diabetes or Hypertension', 'orgStudyIdInfo': {'id': '21C02711'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Monthly $80 grocery support program', 'description': 'The intervention entails the provision of an $80 monthly payment (adjusted by household size) in the form of a re-loadable cash card to be used at food retailers including food retailers who sell non-food item.', 'interventionNames': ['Other: $80 Grocery Support Monthly Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Monthly $120 grocery support program', 'description': 'The active comparator entails the provision of a $120 monthly payment (adjusted by household size) in the form of a re-loadable cash card to be used at food retailers including food retailers who sell non-food item.', 'interventionNames': ['Other: $120 Grocery Support Monthly Program']}], 'interventions': [{'name': '$80 Grocery Support Monthly Program', 'type': 'OTHER', 'description': '$80 monthly (adjusted by household size), re-loadable cash card for use at food retailers', 'armGroupLabels': ['Monthly $80 grocery support program']}, {'name': '$120 Grocery Support Monthly Program', 'type': 'OTHER', 'description': '$120 monthly (adjusted by household size), re-loadable cash card for use at food retailers', 'armGroupLabels': ['Monthly $120 grocery support program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94107', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Laura Gottlieb, MD, MPH', 'role': 'CONTACT', 'email': 'siren@ucsf.edu', 'phone': '415-509-8976'}, {'name': 'Emma Tucher, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Laura M Gottlieb, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Danielle Hessler Jones, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'SIREN 675 18th Street', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Laura Gottlieb, MD, MPH', 'role': 'CONTACT', 'email': 'siren@ucsf.edu', 'phone': '415-509-8976'}, {'name': 'Emma L Tucher, PhD', 'role': 'CONTACT', 'email': 'emma.tucher@ucsf.edu', 'phone': '415-205-4522'}], 'overallOfficials': [{'name': 'Laura M Gottlieb, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Danielle Hessler Jones, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data is not available without a data use agreement with Covered California to protect patient health information in alignment with secure data storage and research ethical practices in alignment with our IRB protocol.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Covered California', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}