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NCT Number: NCT06061861

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Southern California Department of Research & Evaluation, Pasadena, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 6-month change in glycosylated hemoglobin level

    Time frame: 6 months after enrollment

    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.

Secondary outcomes

  1. 12-month change in glycosylated hemoglobin level

    Time frame: 12 months after enrollment

    Glycosylated hemoglobin will be ascertained using routine laboratory tests in the electronic health record at 12 months after enrollment.

  2. Percentage of participants with glycosylated hemoglobin <7.5%

    Time frame: 6- and 12-months after enrollment

    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.

  3. All-cause hospitalizations or emergency department visits

    Time frame: 3-, 6-, and 12-months after enrollment

    Occurrence of hospitalization or emergency department visit for any reason within 12 months after enrollment.

  4. Change in self-reported level of food security

    Time frame: 6- and 12-months after enrollment

    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).

  5. Change in self-reported level of nutrition security

    Time frame: 6- and 12-months after enrollment

    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. Change in self-reported dietary habits

    Time frame: 6- and 12-months after enrollment

    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.

  7. Change in self-reported diabetes-related quality of life

    Time frame: 6- and 12-months after enrollment

    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.

  8. Change in self-reported readiness to change

    Time frame: 6- and 12-months after enrollment

    Participants will be asked about their readiness to change their dietary habits to manage their diabetes on a 5-point Likert scale.

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Registry information

Official study title

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

Acronym: KP ENRICH

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Sep 29, 2023
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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