跳至主要内容
临床试验/NCT07469995
NCT07469995进行中(未招募)不适用

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

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 4,450 人开始时间: 2026年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
4,450
试验地点
1
主要终点
Change in blood pressure

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

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.

干预措施: $80 Grocery Support Monthly Program (Other)

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.

干预措施: $120 Grocery Support Monthly Program (Other)

结局指标

主要结局

Change in blood pressure

时间窗: Baseline, 12 months

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

Change in diabetes and/or hypertension distress

时间窗: 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.

Food insecurity status

时间窗: 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

时间窗: Baseline, 12 months

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

Change in frequency of experiences of hypoglycemia

时间窗: Baseline, 12 months

Measured using the change in self-reported frequency per week that a participant experiences hypoglycemia.

次要结局

  • 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)
  • Outpatient visits(2 years before study start until 12 months after)
  • Self-rated physical and mental health(Baseline, 12 months)
  • Self-reported medication adherence(Baseline, 12 months)
  • Medication adherence(2 years before study start until 12 months after)
  • Medication count(2 years before study start until 12 months after)
  • Cost-based changes to primary care or medication use(Baseline, 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验