The Effect of Grocery Support Dose on Food Insecurity and Disease Control Among Covered California Members With Diabetes or Hypertension

June 3, 2026 updated by: University of California, San Francisco
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4450

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Laura Gottlieb, MD, MPH
  • Phone Number: 415-509-8976
  • Email: siren@ucsf.edu

Study Contact Backup

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94107
        • SIREN 675 18th Street

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • No longer a Covered California member
  • $0 spending in year 1 grocery support program

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Monthly $80 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.
Other: $80 Grocery Support Monthly Program
$80 monthly (adjusted by household size), re-loadable cash card for use at food retailers
Active Comparator: Monthly $120 grocery support program
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.
Other: $120 Grocery Support Monthly Program
$120 monthly (adjusted by household size), re-loadable cash card for use at food retailers

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 12 months
Change in HbA1c
Time Frame: Baseline, 12 months
Change in self-reported HbA1c from baseline by study arm.
Baseline, 12 months
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.
Baseline, 12 months
Change in blood pressure
Time Frame: Baseline, 12 months
Change in self-reported systolic and diastolic blood pressure from baseline by study arm.
Baseline, 12 months
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.
Baseline, 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 12 months
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.
Baseline, 12 months
Acute health care utilization
Time Frame: 2 years before study start until 12 months after
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.
2 years before study start until 12 months after
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.
2 years before study start until 12 months after
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.
2 years before study start until 13 months after
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.
2 years before study start until 12 months after
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.
Baseline, 12 months
Self-reported medication adherence
Time Frame: Baseline, 12 months
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.
Baseline, 12 months
Medication adherence
Time Frame: 2 years before study start until 12 months after
Measured using medical claims data and calculated based on daily supply.
2 years before study start until 12 months after
Medication count
Time Frame: 2 years before study start until 12 months after
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.
2 years before study start until 12 months after
Cost-based changes to primary care or medication use
Time Frame: Baseline, 12 months
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.
Baseline, 12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 12 months
Nutrition security
Time Frame: Baseline, 12 months
Measured using the 14-response options providing reasons why respondents have difficulty eating or not eating healthy foods.
Baseline, 12 months
Self-reported utilization
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.
Baseline, 12 months
Other 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.
Baseline, 12 months
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.
Baseline, 12 months
Self-rated health
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.
Baseline, 12 months
Perceived stress
Time Frame: Baseline, 12 months
Measured using changes in self-report based on a validated, 10-item perceived stress scale.
Baseline, 12 months
Self-efficacy
Time Frame: Baseline, 12 months
Measured using changes in participant responses across the 9-item validated self-efficacy scale.
Baseline, 12 months
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.
Baseline, 12 months
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), days until next admit, and total cost of admissions across the 12 month study period.
2 years before study start until 12 months after.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Francisco

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Covered California

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Laura M Gottlieb, MD, MPH, University of California, San Francisco
  • Principal Investigator: Danielle Hessler Jones, PhD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21C02711

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Clinical Trials on $80 Grocery Support Monthly Program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings