Diabetes Mellitus, Type 2KP ENRICHNCT06061861
Kaiser Permanente Evaluating Nutritional Interventions in Food-Insecure High-Risk Adults Study
A study testing Financial support for healthy foods and free home delivery and Free home delivery in people with Diabetes Mellitus, Type 2, run by Kaiser Permanente at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Financial support for healthy foods and free home delivery and Free home delivery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,007 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2023to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Kaiser Permanente Southern California Department of Research & Evaluation
Pasadena, California, 91101
Kaiser Permanente Northern California Division of Research
Pleasanton, California, 94588
About this study
Official title: Kaiser Permanente Evaluating Nutritional Interventions in Food-Insecure High-Risk Adults (KP ENRICH) 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:
- 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.
Read the detailed description
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Financial support for healthy foods and free home delivery, Free home delivery
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial support for healthy foods and free home deliveryOther
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 deliveryOther
Participants will have home delivery and service fees waived for 4 orders per month through the Instacart platform for a duration of 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Financial Support and Free Delivery | Experimental | The intervention group will receive monthly financial support for healthy food items along with free home delivery through the Instacart platform. Receives: Other: Financial support for healthy foods and free home delivery |
| Free Delivery | Experimental | The control group will receive only free home delivery through the Instacart platform. Receives: Other: Free home delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after enrollment
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6- and 12-months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start1 Oct 2023
- Primary completion27 Dec 2025
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,007 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudia L Nau, PhD, Principal investigator, Kaiser PermanenteRichard Grant, MD, MPH, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061861
- Sponsor's protocol ID
- 2112426
- Acronym
- KP ENRICH
- Status last verified
- Dec 2025
- First submitted
- 12 Sep 2023
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kaiser Permanente Evaluating Nutritional Interventions in Food-Insecure High-Risk Adults (KP ENRICH) Study
- ClinicalTrials.gov ID
- NCT06061861
- Acronym / sponsor ID
- KP ENRICH / 2112426
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,007 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 27 Dec 2025 (actual)
- Study completion
- Jun 2026 (estimated)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Financial Support and Free Delivery | Experimental | Other: Financial support for healthy foods and free home deliveryThe intervention group will receive monthly financial support for healthy food items along with free home delivery through the Instacart platform. |
| Free Delivery | Experimental | Other: Free home deliveryThe control group will receive only free home delivery through the Instacart platform. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Financial support for healthy foods and free home deliveryParticipants 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. | Other | Financial Support and Free Delivery |
| Free home deliveryParticipants will have home delivery and service fees waived for 4 orders per month through the Instacart platform for a duration of 6 months. | Other | Free Delivery |
Primary outcome
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.
8 secondary outcomes
12-month change in glycosylated hemoglobin level
Time frame: 12 months after enrollment
Percentage of participants with glycosylated hemoglobin <7.5%
Time frame: 6- and 12-months after enrollment
All-cause hospitalizations or emergency department visits
Time frame: 3-, 6-, and 12-months after enrollment
Change in self-reported level of food security
Time frame: 6- and 12-months after enrollment
Change in self-reported level of nutrition security
Time frame: 6- and 12-months after enrollment
Change in self-reported dietary habits
Time frame: 6- and 12-months after enrollment
Change in self-reported diabetes-related quality of life
Time frame: 6- and 12-months after enrollment
Change in self-reported readiness to change
Time frame: 6- and 12-months after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia L Nau, PhD principal investigator
Kaiser Permanente
Richard Grant, MD, MPH principal investigator
Kaiser Permanente
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Financial support for healthy foods and free home delivery and Free home delivery in people with Diabetes Mellitus, Type 2, run by Kaiser Permanente at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month change in glycosylated hemoglobin level (time frame: 6 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.