Kaiser Permanente Evaluating Nutritional Interventions in Food-Insecure High-Risk Adults Study (KP ENRICH)

January 6, 2026 updated by: Kaiser Permanente

Kaiser Permanente Evaluating Nutritional Interventions in Food-Insecure High-Risk Adults (KP ENRICH) Study

The goal of this randomized controlled trial is to compare the effect of receiving 6 months of monetary support for healthy food through a food delivery platform on change in glycosylated hemoglobin (HbA1c) levels among adults with type 2 diabetes mellitus with glycemic control that is above target level.

The main study aims are to:

  1. To evaluate whether providing monthly financial support for home-delivered healthy food vs. only free food delivery through the Instacart platform reduces glycosylated hemoglobin levels within 6 months among Medi-Cal-insured Kaiser Permanente adult members with diabetes mellitus and suboptimal glycemic control.
  2. To evaluate whether providing monthly financial support for home-delivered healthy food vs. only free food delivery through the Instacart platform reduces medical resource utilization within 6 months among Medi-Cal-insured Kaiser Permanente adult members with diabetes mellitus and suboptimal glycemic control.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Eligible Kaiser Permanente adult members will be randomized to one of two groups:

  1. Intervention arm, in which subjects will receive 6 months of monetary support (with up to 4 free home deliveries and no service fees) through the Instacart platform to select and receive healthy foods (e.g., vegetables and fruit).
  2. Control arm, in which subjects will receive 6 months of free home deliveries and no service fees for up to 4 deliveries each month through the Instacart platform.

Glycosylated hemoglobin level will be assessed at baseline and at 6 months after enrollment. Medical resource utilization will be evaluated at 3 months, 6 months, and 12 months after enrollment. Patient-reported outcomes (i.e., diabetes quality of life, nutrition security, dietary habits, social needs, and food security) will also be assessed at baseline, 6 months, and 12 months after enrollment.

Study Type

Interventional

Enrollment (Actual)

1007

Phase

  • 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 Locations

  • United States
    • California
      • Pasadena, California, United States, 91101
        • Kaiser Permanente Southern California Department of Research & Evaluation
      • Pleasanton, California, United States, 94588
        • Kaiser Permanente Northern California Division of Research

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged ≥18 years old at enrollment
  • Active membership in Kaiser Permanente with Medi-Cal insurance and no additional private or commercial insurance
  • Diagnosis of Type II diabetes mellitus (not including Type I diabetes mellitus or gestational diabetes mellitus)
  • At least 2 outpatient glycosylated hemoglobin measures ≥7.5% in the prior 18 months
  • Current access to the internet via computer or mobile device
  • No interpreter needed

Exclusion Criteria:

  • Advanced or end-stage kidney disease (estimated glomerular filtration rate ≤15 ml/min/1.73m^2 or receiving outpatient dialysis or having a prior kidney transplant)
  • Known pregnancy at time of identification

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Financial Support and Free Delivery
The intervention group will receive monthly financial support for healthy food items along with free home delivery through the Instacart platform.
Other: Financial support for healthy foods and free home delivery
Participants will receive monetary support to spend on healthy food items (e.g., vegetables and fruit) through the Instacart platform for a duration of 6 months and have home delivery and service fees waived for 4 orders per month through the Instacart platform for a duration of 6 months.
Experimental: Free Delivery
The control group will receive only free home delivery through the Instacart platform.
Other: Free home delivery
Participants will have home delivery and service fees waived for 4 orders per month through the Instacart platform for a duration of 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-month change in glycosylated hemoglobin level
Time Frame: 6 months after enrollment
Baseline glycosylated hemoglobin will be ascertained using routine laboratory tests in the electronic health record prior to enrollment. Participants will complete glycosylated hemoglobin testing 6 months after enrollment.
6 months after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
12-month change in glycosylated hemoglobin level
Time Frame: 12 months after enrollment
Glycosylated hemoglobin will be ascertained using routine laboratory tests in the electronic health record at 12 months after enrollment.
12 months after enrollment
Percentage of participants with glycosylated hemoglobin <7.5%
Time Frame: 6- and 12-months after enrollment
Baseline glycosylated hemoglobin will be ascertained using routine laboratory tests in the electronic health record prior to enrollment. Participants will complete glycosylated hemoglobin tests 6 months after enrollment. 12-month glycosylated hemoglobin level will be ascertained using routine laboratory tests in the electronic health record.
6- and 12-months after enrollment
All-cause hospitalizations or emergency department visits
Time Frame: 3-, 6-, and 12-months after enrollment
Occurrence of hospitalization or emergency department visit for any reason within 12 months after enrollment.
3-, 6-, and 12-months after enrollment
Change in self-reported level of food security
Time Frame: 6- and 12-months after enrollment
Participants will answer 10 questions about their food security using the USDA adult food security module. Affirmative responses to questions will be assigned 1 point in the food security scale (out of 10). Participants will be classified as being food secure (0-2 points) or food insecure (3-10 points).
6- and 12-months after enrollment
Change in self-reported level of nutrition security
Time Frame: 6- and 12-months after enrollment
Participants will be asked about their level of difficulty in accessing healthy food on a 5-point Likert scale. Participants will also be asked 13 questions on reasons for not eating healthy food, with each question scored from 0-2 (Never, Sometimes, Often true). Lower scores indicate higher nutrition security.
6- and 12-months after enrollment
Change in self-reported dietary habits
Time Frame: 6- and 12-months after enrollment
Participants will be asked 8 questions to examine their consumption of fast food, fruits, vegetables, legumes, nuts, dairy, seafood, sweets, and sugar-sweetened beverages over the past month.
6- and 12-months after enrollment
Change in self-reported diabetes-related quality of life
Time Frame: 6- and 12-months after enrollment
Participants will answer 13 questions about their diabetes-related quality of life, each on a 5-point Likert scale. Scores range from 13-65, with higher scores indicating lower diabetes-related quality of life.
6- and 12-months after enrollment
Change in self-reported readiness to change
Time Frame: 6- and 12-months after enrollment
Participants will be asked about their readiness to change their dietary habits to manage their diabetes on a 5-point Likert scale.
6- and 12-months after enrollment

Collaborators and Investigators

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

Sponsor

Kaiser Permanente

Investigators

  • Principal Investigator: Claudia L Nau, PhD, Kaiser Permanente
  • Principal Investigator: Richard Grant, MD, MPH, Kaiser Permanente

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)

October 1, 2023

Primary Completion (Actual)

December 27, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

September 12, 2023

First Submitted That Met QC Criteria

September 25, 2023

First Posted (Actual)

September 29, 2023

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2112426

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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 Diabetes Mellitus, Type 2

Clinical Trials on Financial support for healthy foods and free home delivery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe