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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 3
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Kaiser Permanente Southern California Department of Research & Evaluation
RECRUITING
Pasadena
Kaiser Permanente Northern California Division of Research
RECRUITING
Pleasanton
Contact Information
Primary
Thida C Tan, MPH
thida.x.tan@kp.org
510-891-5982
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 1100
Treatments
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.
Experimental: Free Delivery
The control group will receive only free home delivery through the Instacart platform.
Related Therapeutic Areas
Sponsors
Leads: Kaiser Permanente

This content was sourced from clinicaltrials.gov

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