Kaiser Permanente Evaluating Nutritional Interventions in Food-Insecure High-Risk Adults Study

Description

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.

Conditions

Diabetes Mellitus, Type 2

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Study Overview

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Study Details

Study overview

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.

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

Kaiser Permanente Evaluating Nutritional Interventions in Food-Insecure High-Risk Adults Study

Condition
Diabetes Mellitus, Type 2
Intervention / Treatment

-

Contacts and Locations

Pasadena

Kaiser Permanente Southern California Department of Research & Evaluation, Pasadena, California, United States, 91101

Pleasanton

Kaiser Permanente Northern California Division of Research, Pleasanton, California, United States, 94588

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Kaiser Permanente,

Claudia L Nau, PhD, PRINCIPAL_INVESTIGATOR, Kaiser Permanente

Richard Grant, MD, MPH, PRINCIPAL_INVESTIGATOR, Kaiser Permanente

Study Record Dates

2025-12