DiabetesNCT07469995
The Effect of Grocery Support Dose on Food Insecurity and Disease Control Among Covered California Members With Diabetes or Hypertension
A study testing $80 Grocery Support Monthly Program and $120 Grocery Support Monthly Program in people with Diabetes and Hypertension, run by University of California, San Francisco at 1 site in United States.
Trial summary
This continuation study is a pragmatic randomized controlled trial (RCT) of Covered California's Grocery Support Program among low-income participants with diabetes or hypertension. This pragmatic RCT will compare the efficacy of providing different benefit amounts ($80 vs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Hypertension, Food Insecurity
- What is being tested?
- $80 Grocery Support Monthly Program and $120 Grocery Support Monthly Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,450 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2026to 31 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active Covered California member
- Adult >= 18 years of age
- Has a diabetes and or hypertension diagnosis identifiable in Covered California's administrative claims
- Income <250% FPL
Who cannot join
- No longer a Covered California member
- $0 spending in year 1 grocery support program
Trial locations and contacts
1 site in 1 country.
United States1 site
SIREN 675 18th Street
San Francisco, California, 94107
About this study
This continuation study is a pragmatic randomized controlled trial (RCT) of Covered California's Grocery Support Program among low-income participants with diabetes or hypertension. This pragmatic RCT will compare the efficacy of providing different benefit amounts ($80 vs. $120) via a monthly food card benefit for households where at least one adult has diabetes and/or hypertension and incomes below 250% of the federal poverty level (FPL).
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 diabetes and/or hypertension. Food insecurity, defined by the US 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 diabetes and/or hypertension. In 2025, Covered California initiated the first year of the food insecurity PopHI comparing the impact of an $80 monthly grocery support cash card for 12-months versus a one-time payment at the end of 12-months among a low-income cohort with food insecurity and a chronic condition. Building off year one learnings, Covered California tailored their program design and benefit amount based on findings. While produce prescription and grocery support programs have been shown to reduce food insecurity and improve diet quality, key implementation questions most importantly the impact of varying doses, remain to be understood. The goal of the proposed research is to evaluate the impact of two different doses of a 12-month grocery support program on participant food insecurity and health outcomes among a cohort of individuals with diabetes and/or hypertension. Participants were invited to enroll in the program if they were active members of Covered California at the time of enrollment and had a documented diabetes and/or hypertension diagnosis and an income at or below 250% of the FPL. Participants were randomly assigned to receive either an $80 or $120 reusable semi-restricted cash card re-loaded monthly for one year (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 administrative claims data.
- Being tested
- $80 Grocery Support Monthly Program, $120 Grocery Support Monthly Program
- Keywords
- Health Insurance Exchange, Grocery Support Program, Food Insecurity, Chronic Disease
- Medical subject headings
- Diabetes Mellitus, Hypertension, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
$80 Grocery Support Monthly ProgramOther
$80 monthly (adjusted by household size), re-loadable cash card for use at food retailers
$120 Grocery Support Monthly ProgramOther
$120 monthly (adjusted by household size), re-loadable cash card for use at food retailers
| Study group | Role | What they receive |
|---|---|---|
| Monthly $80 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: $80 Grocery Support Monthly Program |
| Monthly $120 grocery support program | Active comparator | The active comparator entails the provision of a $120 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: $120 Grocery Support Monthly Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food insecurity status
Measured by 2-item Hunger Vital Sign, a validated tool to assess food insecurity. Higher scores indicate greater food insecurity.
Measured: Baseline, 12 months
Change in HbA1c
Change in self-reported HbA1c from baseline by study arm.
Measured: Baseline, 12 months
Change in frequency of experiences of hypoglycemia
Measured using the change in self-reported frequency per week that a participant experiences hypoglycemia.
Measured: Baseline, 12 months
Change in blood pressure
Change in self-reported systolic and diastolic blood pressure from baseline by study arm.
Measured: Baseline, 12 months
Change in diabetes and/or hypertension distress
The change is measured using an adapted 10-item version of the validated 17-item Diabetes and Hypertension Distress Scale, where each item ranges from 1-5, mean score ranges from 1-5, and total score is 10-50 with higher scores indicating greater diabetes- and hypertension-related distress.
Measured: Baseline, 12 months
Secondary outcomes (11)
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
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
Acute health care utilization
Proportion of participants that used the 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
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
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
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
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
Self-reported medication adherence
Measured as an affirmative response to cost-based medication nonadherence and 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.
Measured: Baseline, 12 months
Medication adherence
Measured using medical claims data and calculated based on daily supply.
Measured: 2 years before study start until 12 months after
Medication count
Measured using the survey and medical claims as the total number of medications that the participant had at baseline and across the 12-month study period.
Measured: 2 years before study start until 12 months after
Cost-based changes to primary care or medication use
Measured using a 5-response question (never to often) to delays to medical care because of cost and a binary (yes/no) response to a question about cost-related medication nonadherence.
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 posted13 Mar 2026
- Study start15 Mar 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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 will be randomized into either intervention arm ($80 vs. $120) at a 3:1 ratio. They will be stratified by preferred language (English vs. non-English) and Covered California metal tier (Silver vs. Bronze). The intervention consists of an $80 or $120 monthly 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
- 4,450 participants (estimated)
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 FranciscoDanielle Hessler Jones, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469995
- Sponsor's protocol ID
- 21C02711
- Status last verified
- Jun 2026
- First submitted
- 10 Mar 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is not available without a data use agreement with Covered California to protect patient health information in alignment with secure data storage and research ethical practices in alignment with our IRB protocol.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Grocery Support Dose on Food Insecurity and Disease Control Among Covered California Members With Diabetes or Hypertension
- ClinicalTrials.gov ID
- NCT07469995
- Acronym / sponsor ID
- 21C02711
- Keywords
- Health Insurance Exchange, Grocery Support Program, Food Insecurity, Chronic Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,450 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Covered California
- Study start
- 15 Mar 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Mar 2026 (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 continuation study is a pragmatic randomized controlled trial (RCT) of Covered California's Grocery Support Program among low-income participants with diabetes or hypertension. This pragmatic RCT will compare the efficacy of providing different benefit amounts ($80 vs. $120) via a monthly food card benefit for households where at least one adult has diabetes and/or hypertension and incomes below 250% of the federal poverty level (FPL).
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 diabetes and/or hypertension. Food insecurity, defined by the US 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 diabetes and/or hypertension. In 2025, Covered California initiated the first year of the food insecurity PopHI comparing the impact of an $80 monthly grocery support cash card for 12-months versus a one-time payment at the end of 12-months among a low-income cohort with food insecurity and a chronic condition. Building off year one learnings, Covered California tailored their program design and benefit amount based on findings. While produce prescription and grocery support programs have been shown to reduce food insecurity and improve diet quality, key implementation questions most importantly the impact of varying doses, remain to be understood. The goal of the proposed research is to evaluate the impact of two different doses of a 12-month grocery support program on participant food insecurity and health outcomes among a cohort of individuals with diabetes and/or hypertension. Participants were invited to enroll in the program if they were active members of Covered California at the time of enrollment and had a documented diabetes and/or hypertension diagnosis and an income at or below 250% of the FPL. Participants were randomly assigned to receive either an $80 or $120 reusable semi-restricted cash card re-loaded monthly for one year (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 administrative claims data.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized into either intervention arm ($80 vs. $120) at a 3:1 ratio. They will be stratified by preferred language (English vs. non-English) and Covered California metal tier (Silver vs. Bronze). The intervention consists of an $80 or $120 monthly 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 $80 grocery support program | Experimental | Other: $80 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. |
| Monthly $120 grocery support program | Active comparator | Other: $120 Grocery Support Monthly ProgramThe active comparator entails the provision of a $120 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Active Covered California member
- Adult >= 18 years of age
- Has a diabetes and or hypertension diagnosis identifiable in Covered California's administrative claims
- Income <250% FPL
Key exclusion criteria (2 listed)
- No longer a Covered California member
- $0 spending in year 1 grocery support program
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 |
|---|---|---|
| $80 Grocery Support Monthly Program$80 monthly (adjusted by household size), re-loadable cash card for use at food retailers | Other | Monthly $80 grocery support program |
| $120 Grocery Support Monthly Program$120 monthly (adjusted by household size), re-loadable cash card for use at food retailers | Other | Monthly $120 grocery support program |
Primary outcome
Food insecurity status
Time frame: Baseline, 12 months
Measured by 2-item Hunger Vital Sign, a validated tool to assess food insecurity. Higher scores indicate greater food insecurity.
Change in HbA1c
Time frame: Baseline, 12 months
Change in self-reported HbA1c from baseline by study arm.
Change in frequency of experiences of hypoglycemia
Time frame: Baseline, 12 months
Measured using the change in self-reported frequency per week that a participant experiences hypoglycemia.
Change in blood pressure
Time frame: Baseline, 12 months
Change in self-reported systolic and diastolic blood pressure from baseline by study arm.
Change in diabetes and/or hypertension distress
Time frame: Baseline, 12 months
The change is measured using an adapted 10-item version of the validated 17-item Diabetes and Hypertension Distress Scale, where each item ranges from 1-5, mean score ranges from 1-5, and total score is 10-50 with higher scores indicating greater diabetes- and hypertension-related distress.
11 secondary outcomes
Nutrition security
Time frame: Baseline, 12 months
Diet quality
Time frame: Baseline, 12 months
Acute health care utilization
Time frame: 2 years before study start until 12 months after
Hospital admissions
Time frame: 2 years before study start until 12 months after
Hospital readmissions
Time frame: 2 years before study start until 13 months after
Outpatient visits
Time frame: 2 years before study start until 12 months after
Self-rated physical and mental health
Time frame: Baseline, 12 months
Self-reported medication adherence
Time frame: Baseline, 12 months
Medication adherence
Time frame: 2 years before study start until 12 months after
Medication count
Time frame: 2 years before study start until 12 months after
Cost-based changes to primary care or medication use
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 4 Jun 2026.
- Individual participant dataSharing planned: No. Data is not available without a data use agreement with Covered California to protect patient health information in alignment with secure data storage and research ethical practices in alignment with our IRB protocol.
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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
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 $80 Grocery Support Monthly Program and $120 Grocery Support Monthly Program in people with Diabetes and Hypertension, 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 4 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 4 Jun 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?
Food insecurity status (time frame: Baseline, 12 months). The study lists 5 primary outcomes in all. 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 4 Jun 2026.