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

NCT07469995 | Active Not Recruiting

• 1 other identifier: 21C02711
• Study Type: interventional
• Target: 4,450
• Locations: 1 country
• Sites: 1

Brief 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. $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).

Conditions

Diabetes; Hypertension; Food Insecurity; Low-Income Population; Insurance Coverage

Keywords

Health Insurance Exchange; Grocery Support Program; Food Insecurity; Chronic Disease

Outcome Measures

Primary Outcomes (5)

• Food insecurity status

  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

  Change in self-reported HbA1c from baseline by study arm.

  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.

  Baseline, 12 months

• Change in blood pressure

  Change in self-reported systolic and diastolic blood pressure from baseline by study arm.

  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.

  Baseline, 12 months

Secondary Outcomes (11)

• Nutrition security

  Baseline, 12 months

• Diet quality

  Baseline, 12 months

• Acute health care utilization

  2 years before study start until 12 months after

• Hospital admissions

  2 years before study start until 12 months after

• Hospital readmissions

  2 years before study start until 13 months after

Other Outcomes (10)

• Low food security

  Baseline, 12 months

• Nutrition security

  Baseline, 12 months

• Self-reported utilization

  Baseline, 12 months

Study Arms (2)

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.

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.

Other: $120 Grocery Support Monthly Program

Interventions

$80 Grocery Support Monthly Program OTHER

$80 monthly (adjusted by household size), re-loadable cash card for use at food retailers

Monthly $80 grocery support program

$120 Grocery Support Monthly Program OTHER

$120 monthly (adjusted by household size), re-loadable cash card for use at food retailers

Monthly $120 grocery support program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Covered California: collaborator
• University of California, San Francisco: lead

Study Sites (1)

SIREN 675 18th Street

San Francisco, California, 94107, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension; Chronic Disease

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Laura M Gottlieb, MD, MPH

  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
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 13, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)