Chronic Conditions, MultipleNCT07215897
Evaluating Covered California's Grocery Support Program
A study testing Grocery Support Monthly Program and Grocery Support One-Time Payment in people with Chronic Conditions, Multiple and Chronic Conditions, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Conditions, Multiple, Chronic Conditions, Food Insecurity
- What is being tested?
- Grocery Support Monthly Program and Grocery Support One-Time Payment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,975 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2025to 30 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Negative for food insecurity via 2-item Hunger Vital Sign
- Income ≥250% federal poverty level
Trial locations and contacts
1 site in 1 country.
United States1 site
Social Interventions Research and Evaluation Network (SIREN), University of California, San Francisco
San Francisco, California, 94107
About this study
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.
Read the 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.
- Being tested
- Grocery Support Monthly Program, Grocery Support One-Time Payment
- Keywords
- chronic conditions, food insecurity, grocery benefit, low-income
- Medical subject headings
- Multiple Chronic Conditions, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grocery Support Monthly ProgramOther
$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 PaymentOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Grocery Support One-Time Payment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 12 months
Secondary outcomes (7)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2025
- Study start1 Feb 2025
- Primary completion9 Mar 2026
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Conditions, MultipleStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 6,975 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Covered California
- Responsible party
- Sponsor
- Investigators
- Laura M Gottlieb, MD, MPH, Principal investigator, University of California, San FranciscoCaroline Fichtenberg, PhD, Principal investigator, University of California, San FranciscoDanielle Hessler Jones, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07215897
- Sponsor's protocol ID
- 24-42548
- Other IDs
- 21-C027-11
- Status last verified
- Jul 2026
- First submitted
- 7 Oct 2025
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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).
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Covered California's Grocery Support Program
- ClinicalTrials.gov ID
- NCT07215897
- Acronym / sponsor ID
- 24-42548
- Keywords
- chronic conditions, food insecurity, grocery benefit, low-income
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6,975 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Covered California
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 9 Mar 2026 (actual)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 14 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Monthly grocery support program | Experimental | Other: Grocery Support Monthly ProgramThe 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. |
| One-time grocery support payment | Active comparator | Other: Grocery Support One-Time PaymentAt 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Negative for food insecurity via 2-item Hunger Vital Sign
- Income ≥250% federal poverty level
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Monthly grocery support program |
| Grocery Support One-Time PaymentNo 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 | Other | One-time grocery support payment |
Primary outcome
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
7 secondary outcomes
Change in nutrition security
Time frame: Baseline, 12 months
Change in diet quality
Time frame: Baseline, 12 months
Proportion of participants with acute health care utilization
Time frame: 2 years before study start until 12 months after
Proportion of hospital admissions
Time frame: 2 years before study start until 12 months after
Proportion of hospital readmissions
Time frame: 2 years before study start until 13 months after
Number of outpatient visits
Time frame: 2 years before study start until 12 months after
Change in self-rated physical and mental health
Time frame: Baseline, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No. 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).
Related trials for Chronic Conditions, Multiple
RecruitingPhase 1
A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders
B-cell Mediated Autoimmune Disorders
RecruitingPhase 3
A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
Multiple Sclerosis (MS) Primary Progressive
RecruitingPhase 3
A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
RecruitingObservational study
REAL-MS: Observational Database Study of AHSCT and MS Therapies
Multiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting
Not yet recruitingObservational study
Union-LC-MPE Cohort:A Multicenter Cohort Study on Diagnosis and Prognosis of Malignant Pleural Effusion in Lung Cance
Malignant Pleural Effusions (Mpe), Lung Cancer (Diagnosis)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura M Gottlieb, MD, MPH principal investigator
University of California, San Francisco
Caroline Fichtenberg, PhD principal investigator
University of California, San Francisco
Danielle Hessler Jones, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grocery Support Monthly Program and Grocery Support One-Time Payment in people with Chronic Conditions, Multiple and Chronic Conditions, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in food insecurity status (time frame: Baseline, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.