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OpenTrials
Active, Not Recruiting

NCT Number: NCT07215897

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Social Interventions Research and Evaluation Network (SIREN), University of California, San Francisco

San Francisco, California, 94107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Grocery Support Monthly Program

Other

$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

Grocery Support One-Time Payment

Other

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

Primary outcomes

  1. Change in food insecurity status

    Time frame: Baseline, 12 months

    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

Secondary outcomes

  1. Change in nutrition security

    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.

  2. Change in diet quality

    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

  3. Proportion of participants with acute health care utilization

    Time frame: 2 years before study start until 12 months after

    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

  4. Proportion of hospital admissions

    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

  5. Proportion of hospital readmissions

    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

  6. Number of outpatient visits

    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

  7. Change in self-rated physical and mental health

    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

Other outcomes

  1. Change in proportion of participants with low food security

    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

  2. Change in why participants could not/did not eat healthy foods

    Time frame: Baseline, 12 months

    Measured using the 14-response options providing reasons why respondents have difficulty eating or not eating healthy foods

  3. Change in self-reported number of health visits

    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

  4. Change in prevalence of social risks

    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

  5. Change in frequency and severity of trade-offs

    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

  6. Change in Patient-Reported Outcomes Measurement Information System 10-item (PROMIS-10) physical and mental health scale

    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

  7. Change in cost-based primary care use

    Time frame: Baseline, 12 months

    Measured using a 5-response question (never to often) to delays to medical care because of cost where often is a worse outcome.

  8. Change in perceived stress

    Time frame: Baseline, 12 months

    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

  9. Change in general self-efficacy

    Time frame: Baseline, 12 months

    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

  10. Change in chronic disease self-efficacy

    Time frame: Baseline, 12 months

    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

  11. Change in utilization characteristics

    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), and days until next admit across the 12-month study period

  12. Change in self-reported medication adherence

    Time frame: Baseline, 12 months

    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

  13. Change in claims-based medication adherence

    Time frame: 2 years before study start until 12 months after

    Measured using medical claims data and calculated based on daily supply

  14. Change in claims-based medication count

    Time frame: 2 years before study start until 12 months after

    Measured in the medical claims as the total number of medications that the participant had at baseline and across the 12-month study period

  15. Change in HbA1c

    Time frame: Baseline, 12 months

    Change in self-reported HbA1c from baseline by study arm

  16. Change in utilization costs

    Time frame: 2 years before study start until 12 months after

    Total cost of utilization across study period for inpatient and outpatient utilization

  17. Change in self-reported days of medication adherence

    Time frame: Baseline, 12 months

    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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Covered California

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Oct 14, 2025
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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