SIREN 675 18th Street
San Francisco, California, 94107, United States
NCT Number: NCT07469995
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).
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Not applicable
San Francisco, California, 94107, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
$80 monthly (adjusted by household size), re-loadable cash card for use at food retailers
$120 monthly (adjusted by household size), re-loadable cash card for use at food retailers
Time frame: Baseline, 12 months
Measured by 2-item Hunger Vital Sign, a validated tool to assess food insecurity. Higher scores indicate greater food insecurity.
Time frame: Baseline, 12 months
Change in self-reported HbA1c from baseline by study arm.
Time frame: Baseline, 12 months
Measured using the change in self-reported frequency per week that a participant experiences hypoglycemia.
Time frame: Baseline, 12 months
Change in self-reported systolic and diastolic blood pressure from baseline by study arm.
Time frame: Baseline, 12 months
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.
Time frame: Baseline, 12 months
Measured using the one-item response allowing calculation of the proportion of participants that report difficulty getting and eating healthy foods.
Time frame: Baseline, 12 months
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.
Time frame: 2 years before study start until 12 months after
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.
Time frame: 2 years before study start until 12 months after
Proportion of participants who were hospitalized at least once and count of total hospitalizations from baseline to 12 months by study arm.
Time frame: 2 years before study start until 13 months after
Proportion of participants who were re-hospitalized within 30-days of the index hospitalization by study arm.
Time frame: 2 years before study start until 12 months after
Number of primary care provider, specialist, mental health, and addiction medicine visits across the 12 month study period by study arm.
Time frame: Baseline, 12 months
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.
Time frame: Baseline, 12 months
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.
Time frame: 2 years before study start until 12 months after
Measured using medical claims data and calculated based on daily supply.
Time frame: 2 years before study start until 12 months after
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.
Time frame: Baseline, 12 months
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.
Time frame: Baseline, 12 months
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.
Time frame: Baseline, 12 months
Measured using the 14-response options providing reasons why respondents have difficulty eating or not eating healthy foods.
Time frame: Baseline, 12 months
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.
Time frame: Baseline, 12 months
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.
Time frame: Baseline, 12 months
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.
Time frame: Baseline, 12 months
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.
Time frame: Baseline, 12 months
Measured using changes in self-report based on a validated, 10-item perceived stress scale.
Time frame: Baseline, 12 months
Measured using changes in participant responses across the 9-item validated self-efficacy scale.
Time frame: Baseline, 12 months
Measured using changes in participant responses across the validated, two-item chronic disease self-efficacy scale.
Time frame: 2 years before study start until 12 months after.
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.
University of California, San Francisco
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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