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

Diabetes Mellitus, Type 2 Clinical Trial

— KP ENRICH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06061861
• Other study ID #: 2112426
• Status: Recruiting
• Phase: Phase 3
• Start date: October 1, 2023
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Kaiser Permanente
• Contact: Thida C Tan, MPH
• Phone: 510-891-5982
• Email: thida.x.tan[@]kp.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1100
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Other:
• Financial support for healthy foods and free home delivery
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.
• Free home delivery
Participants will have home delivery and service fees waived for 4 orders per month through the Instacart platform for a duration of 6 months.

Locations

Country	Name	City	State
United States	Kaiser Permanente Southern California Department of Research & Evaluation	Pasadena	California
United States	Kaiser Permanente Northern California Division of Research	Pleasanton	California

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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