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

NCT06061861 | Active Not Recruiting

• 1 other identifier: 2112426
• Study Type: interventional
• Target: 1,007
• Locations: 1 country
• Sites: 2

Brief Summary

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. 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. 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

Outcome Measures

Primary Outcomes (1)

• 6-month change in glycosylated hemoglobin level

  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 Outcomes (8)

• 12-month change in glycosylated hemoglobin level

  12 months after enrollment

• Percentage of participants with glycosylated hemoglobin <7.5%

  6- and 12-months after enrollment

• All-cause hospitalizations or emergency department visits

  3-, 6-, and 12-months after enrollment

• Change in self-reported level of food security

  6- and 12-months after enrollment

• Change in self-reported level of nutrition security

  6- and 12-months after enrollment

Study Arms (2)

Financial Support and Free Delivery

EXPERIMENTAL

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

Free Delivery

EXPERIMENTAL

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

Other: Free home delivery

Interventions

Free home delivery OTHER

Participants will have home delivery and service fees waived for 4 orders per month through the Instacart platform for a duration of 6 months.

Free Delivery

Financial support for healthy foods and free home delivery OTHER

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.

Financial Support and Free Delivery

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (2)

Kaiser Permanente Southern California Department of Research & Evaluation

Pasadena, California, 91101, United States

Location

Kaiser Permanente Northern California Division of Research

Pleasanton, California, 94588, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Financial Support

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations

Study Officials

• Claudia L Nau, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

• Richard Grant, MD, MPH

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 29, 2023
• Study Start: October 1, 2023
• Primary Completion: December 27, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 8, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)