Evaluating Covered California's Grocery Support Program

This is a pragmatic randomized controlled trial (RCT) of Covered California's Grocery Support Program. This pragmatic RCT will test the efficacy of providing a monthly food card benefit for adults with food insecurity, a chronic condition, and incomes below 250% of the federal poverty level (FPL) compared with a group who receives a lump sum payment.

Study Overview

• Status: Active, not recruiting
• Conditions: Food Insecurity; Low-Income Population; Chronic Conditions, Multiple; Chronic Conditions
• Intervention / Treatment: Other: Grocery Support Monthly Program; Other: Grocery Support One-Time Payment

Detailed Description

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 chronic diseases. Food insecurity, defined by the United States 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 chronic disease. The burden of disease is high among Covered California members; for every 1,000 Covered California enrollees with one or more years of continuous enrollment, 390 have a chronic disease diagnosis. The goal of the proposed research is to evaluate the impact of a 12-month grocery support program on participant food insecurity and other outcomes compared to a single payment at the end of 12 months. Participants were invited to enroll in the program if they were active members of Covered California at the time of enrollment, and had 1) a documented chronic condition, 2) food insecurity measured using the validated two-item screener), and 3) an income at or below 250% of the FPL. Participants were randomly assigned to receive either an $80 reusable semi-restricted cash card re-loaded monthly for one year or a one-time cash card of $960 (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 claims data.

Specific Aims are to:

Aim 1 - To evaluate the impact of the grocery support program on participant food insecurity and other dietary outcomes.

H1: Participants who receive the monthly payment will have decreased rates of food insecurity and improved dietary outcomes 12-months after participating compared to participants who do not receive the monthly payment.

Aim 2 - To assess the impact of the grocery support program on self-rated health, healthcare experiences, and social risks and other quality of life measures.

H1: Participants who receive the monthly payment will have improved self-rated health, healthcare experiences, and quality of life, and fewer social risks compared to participants who do not receive the monthly payment.

Aim 3 - To analyze the impact of the grocery support program on participant's health utilization and outcomes.

H1: Relative to participants who do not receive the monthly payment, Grocery Support Program participants will have fewer hospitalizations and Emergency Department (ED) visits and more primary care visits.

H2: Relative to participants who do not receive the monthly payment, Grocery Support Program participants will have greater improvements in chronic disease clinical outcomes.

• Study Type: Interventional
• Enrollment (Actual): 6975
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94107
      • Social Interventions Research and Evaluation Network (SIREN), University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Members of the household are eligible to participate if the recruited participant:

• Active Covered California member
• Adult >= 18 years of age
• Has a chronic condition identifiable in Covered California's medical claims
• Screened positive for food insecurity via 2-item Hunger Vital Sign
• Income <250% federal poverty level

Exclusion Criteria:

• Negative for food insecurity via 2-item Hunger Vital Sign
• Income ≥250% federal poverty level

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Monthly grocery support program; 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.	Other: Grocery Support Monthly Program; $80 monthly (adjusted by household size), re-loadable cash card for use at food retailers to purchase fresh and packaged foods, baby food and formula, and/or non-alcoholic drinks
Active Comparator: One-time grocery support payment; At the end of the study period (12 months), active comparator participants are provided a lump sum payment of $960 (adjusted by household size) as a re-loadable cash card to use at food retailers. No intervention is provided during the 12-month evaluation period.	Other: Grocery Support One-Time Payment; No intervention is provided during the 12-month evaluation period. A $960 one-time (adjusted by household size) cash card for use at food retailers provided after the 12 month evaluation period to purchase fresh and packaged foods, baby food and formula, and/or non-alcoholic drinks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in food insecurity status	Measured by 2-item Hunger Vital Sign, a validated tool to assess food insecurity. Responses that indicate that food sometimes or often did not last or ran out before the end of the month indicate food insecurity	Baseline, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in nutrition security	Measured using the one-item response allowing calculation of the proportion of participants that report difficulty getting and eating healthy foods.	Baseline, 12 months
Change in diet quality	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	Baseline, 12 months
Proportion of participants with acute health care utilization	Proportion of participants that used the emergency department (ED) or had a treat and release ED or observation room visit and number of visits by study arm	2 years before study start until 12 months after
Proportion of hospital admissions	Proportion of participants who were hospitalized at least once and count of total hospitalizations from baseline to 12 months by study arm	2 years before study start until 12 months after
Proportion of hospital readmissions	Proportion of participants who were re-hospitalized within 30-days of the index hospitalization by study arm	2 years before study start until 13 months after
Number of outpatient visits	Number of primary care provider, specialist, mental health, and addiction medicine visits across the 12 month study period by study arm	2 years before study start until 12 months after
Change in self-rated physical and mental health	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	Baseline, 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in proportion of participants with low food security	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	Baseline, 12 months
Change in why participants could not/did not eat healthy foods	Measured using the 14-response options providing reasons why respondents have difficulty eating or not eating healthy foods	Baseline, 12 months
Change in self-reported number of health visits	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	Baseline, 12 months
Change in prevalence of social risks	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	Baseline, 12 months
Change in frequency and severity of trade-offs	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	Baseline, 12 months
Change in Patient-Reported Outcomes Measurement Information System 10-item (PROMIS-10) physical and mental health scale	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	Baseline, 12 months
Change in cost-based primary care use	Measured using a 5-response question (never to often) to delays to medical care because of cost where often is a worse outcome.	Baseline, 12 months
Change in perceived stress	Measured using changes in self-report based on a validated, 4-item perceived stress scale (PSS-4); scores range from 0-16 and higher scores correspond to higher perceived stress	Baseline, 12 months
Change in general self-efficacy	Measured using changes in participant responses across the 10-item validated self-efficacy scale; scores range from 10-40 with higher scores corresponding to higher perceived general self-efficacy	Baseline, 12 months
Change in chronic disease self-efficacy	Measured using changes in participant responses across the validated, two-item chronic disease self-efficacy scale; scores range from 1 to 10 with higher scores relating to higher chronic disease self-efficacy	Baseline, 12 months
Change in utilization characteristics	Measured using claims data to analyze utilization characteristics e.g., length of stay (total days, average number of days per stay), and days until next admit across the 12-month study period	2 years before study start until 12 months after.
Change in self-reported medication adherence	Measured as an affirmative response to cost-based medication nonadherence; change measured as a negative to affirmative or vice-versa response from baseline by study arm	Baseline, 12 months
Change in claims-based medication adherence	Measured using medical claims data and calculated based on daily supply	2 years before study start until 12 months after
Change in claims-based medication count	Measured in the medical claims as the total number of medications that the participant had at baseline and across the 12-month study period	2 years before study start until 12 months after
Change in HbA1c	Change in self-reported HbA1c from baseline by study arm	Baseline, 12 months
Change in utilization costs	Total cost of utilization across study period for inpatient and outpatient utilization	2 years before study start until 12 months after
Change in self-reported days of medication adherence	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. More days corresponds to higher medication nonadherence	Baseline, 12 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Covered California
• Investigators: Principal Investigator: Laura M Gottlieb, MD, MPH, University of California, San Francisco; Principal Investigator: Danielle Hessler Jones, PhD, University of California, San Francisco; Principal Investigator: Caroline Fichtenberg, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: October 7, 2025
• First Submitted That Met QC Criteria: October 8, 2025
• First Posted (Estimated): October 14, 2025

Study Record Updates

• Last Update Posted (Estimated): October 15, 2025
• Last Update Submitted That Met QC Criteria: October 13, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: food insecurity; low-income; chronic conditions; grocery benefit
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Multiple Chronic Conditions; Chronic Disease
• Other Study ID Numbers: 24-42548; 21-C027-11 (Other Grant/Funding Number: Covered California)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: These data are available to researchers at SIREN (UCSF) via a data use agreement and cannot be shared without authorization and release of information by the data's owners (Covered California).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No