NCT07215897

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,975

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress80%
Feb 2025Aug 2026

Study Start

First participant enrolled

February 1, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 14, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Expected
Last Updated

October 15, 2025

Status Verified

October 1, 2025

Enrollment Period

1.2 years

First QC Date

October 7, 2025

Last Update Submit

October 13, 2025

Conditions

Keywords

chronic conditionsfood insecuritygrocery benefitlow-income

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Change in nutrition security

    Baseline, 12 months

  • Change in diet quality

    Baseline, 12 months

  • Proportion of participants with acute health care utilization

    2 years before study start until 12 months after

  • Proportion of hospital admissions

    2 years before study start until 12 months after

  • Proportion of hospital readmissions

    2 years before study start until 13 months after

  • +2 more secondary outcomes

Other Outcomes (17)

  • Change in proportion of participants with low food security

    Baseline, 12 months

  • Change in why participants could not/did not eat healthy foods

    Baseline, 12 months

  • Change in self-reported number of health visits

    Baseline, 12 months

  • +14 more other outcomes

Study Arms (2)

Monthly grocery support program

EXPERIMENTAL

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

One-time grocery support payment

ACTIVE COMPARATOR

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

Interventions

$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

Monthly grocery support program

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

One-time grocery support payment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

San Francisco, California, 94107, United States

Location

MeSH Terms

Conditions

Multiple Chronic ConditionsChronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Laura M Gottlieb, MD, MPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR
  • Caroline Fichtenberg, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR
  • Danielle Hessler Jones, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Participants (n=6,975) were randomized into the intervention n=3,486) or active comparator (n=3,489) stratified by preferred language (English vs. non-English) and Covered California metal tier (Silver vs. Bronze). The intervention consists of a monthly or lump sum grocery support program provided in the form of a reloadable cash card usable at food retailers including those that sell non-food items.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2025

First Posted

October 14, 2025

Study Start

February 1, 2025

Primary Completion

April 30, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

October 15, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

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).

Locations