Clinical trial NCT06061861: Kaiser Permanente Evaluating Nutritional Interventions in Food-Insecure High-Risk Adults Study
Official title: Kaiser Permanente Evaluating Nutritional Interventions in Food-Insecure High-Risk Adults (KP ENRICH) Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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. 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 6-month change in glycosylated hemoglobin level
timeFrame: 6 months after enrollment
Secondary outcomes:
measure: 12-month change in glycosylated hemoglobin level
timeFrame: 12 months after enrollment
measure: Percentage of participants with glycosylated hemoglobin <7.5%
timeFrame: 6- and 12-months after enrollment
measure: All-cause hospitalizations or emergency department visits
timeFrame: 3-, 6-, and 12-months after enrollment
measure: Change in self-reported level of food security
timeFrame: 6- and 12-months after enrollment
measure: Change in self-reported level of nutrition security
timeFrame: 6- and 12-months after enrollment
measure: Change in self-reported dietary habits
timeFrame: 6- and 12-months after enrollment
measure: Change in self-reported diabetes-related quality of life
timeFrame: 6- and 12-months after enrollment
measure: Change in self-reported readiness to change
timeFrame: 6- and 12-months after enrollment
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Kaiser Permanente Southern California Department of Research & Evaluation
state: California
city: Pleasanton
country: United States
facility: Kaiser Permanente Northern California Division of Research
state: California
Study officials:
affiliation: Kaiser Permanente
name: Claudia L Nau, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaiser Permanente
name: Richard Grant, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: