Evaluating Covered California's Grocery Support Program

NCT ID: NCT07215897

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 6975 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2026-08-30

Brief Summary

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.

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.

Conditions

Chronic Conditions, Multiple; Chronic Conditions; Food Insecurity; Low-Income Population

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Grocery Support Monthly Program

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Grocery Support One-Time Payment

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Covered California

OTHER_GOV

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura M Gottlieb, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Caroline Fichtenberg, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Danielle Hessler Jones, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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

San Francisco, California, United States

Countries

United States

Other Identifiers

21-C027-11

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

24-42548

Identifier Type: -

Identifier Source: org_study_id