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

Kaiser Permanente

Status and phase: Enrolling; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Other: Free home delivery; Other: Financial support for healthy foods and free home delivery

Study type: Interventional

Funder types: Other

Identifiers

NCT06061861

2112426

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,100 participants in 2 patient groups

Financial Support and Free Delivery

Experimental group

Description:

The intervention group will receive monthly financial support for healthy food items along with free home delivery through the Instacart platform.

Treatment:

Other: Financial support for healthy foods and free home delivery

Free Delivery

Experimental group

Description:

The control group will receive only free home delivery through the Instacart platform.

Treatment:

Other: Free home delivery