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

Study Overview
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Brief Summary
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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: 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. 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
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Eligible Kaiser Permanente adult members will be randomized to one of two groups: 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). 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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: Financial support for healthy foods and free home delivery
* Other: Free home delivery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Financial Support and Free Delivery<br>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<br>* 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.<br>|
| Experimental: Free Delivery<br>The control group will receive only free home delivery through the Instacart platform. | Other: Free home delivery<br>* Participants will have home delivery and service fees waived for 4 orders per month through the Instacart platform for a duration of 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12-month change in glycosylated hemoglobin level | Glycosylated hemoglobin will be ascertained using routine laboratory tests in the electronic health record at 12 months after enrollment. | 12 months after enrollment | 
| Percentage of participants with glycosylated hemoglobin <7.5% | Baseline glycosylated hemoglobin will be ascertained using routine laboratory tests in the electronic health record prior to enrollment. Participants will complete glycosylated hemoglobin tests 6 months after enrollment. 12-month glycosylated hemoglobin level will be ascertained using routine laboratory tests in the electronic health record. | 6- and 12-months after enrollment | 
| All-cause hospitalizations or emergency department visits | Occurrence of hospitalization or emergency department visit for any reason within 12 months after enrollment. | 3-, 6-, and 12-months after enrollment | 
| Change in self-reported level of food security | Participants will answer 10 questions about their food security using the USDA adult food security module. Affirmative responses to questions will be assigned 1 point in the food security scale (out of 10). Participants will be classified as being food secure (0-2 points) or food insecure (3-10 points). | 6- and 12-months after enrollment | 
| Change in self-reported level of nutrition security | Participants will be asked about their level of difficulty in accessing healthy food on a 5-point Likert scale. Participants will also be asked 13 questions on reasons for not eating healthy food, with each question scored from 0-2 (Never, Sometimes, Often true). Lower scores indicate higher nutrition security. | 6- and 12-months after enrollment | 
| Change in self-reported dietary habits | Participants will be asked 8 questions to examine their consumption of fast food, fruits, vegetables, legumes, nuts, dairy, seafood, sweets, and sugar-sweetened beverages over the past month. | 6- and 12-months after enrollment | 
| Change in self-reported diabetes-related quality of life | Participants will answer 13 questions about their diabetes-related quality of life, each on a 5-point Likert scale. Scores range from 13-65, with higher scores indicating lower diabetes-related quality of life. | 6- and 12-months after enrollment | 
| Change in self-reported readiness to change | Participants will be asked about their readiness to change their dietary habits to manage their diabetes on a 5-point Likert scale. | 6- and 12-months after enrollment |