Diabetes Mellitus, Type 2NCT05407376
Food As Medicine Study
A study testing Produce prescription (weekly produce delivery) in people with Diabetes Mellitus, Type 2, run by Kaiser Permanente at 1 site in United States.
Trial summary
The investigators are conducting a pre-randomized controlled trial to assess the effect of a 6 month Produce Prescription intervention for patients enrolled in Medicaid who experience consistently uncontrolled Hemoglobin A1c (HbA1c). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Produce prescription (weekly produce delivery)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2021to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years of age or older
- Diagnosed with Type 2 Diabetes for at least 24 months
- Diagnosed with Type 2 Diabetes and have at least two HbA1cs of 7.5% or higher in 12 months prior to recruitment
- Have MediCaid insurance at the time of their last hba1c test
- Will be able to provide informed consent
- Will be able to consent to research activities, including receiving a weekly produce box
- Will be able to receive and prepare delivered foods
Who cannot join
- Pregnant women
- Living in a board and care where your meals are provided for you
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Southern California
Pasadena, California, 91101
About this study
Official title: Produce Prescriptions At Kaiser Permanente Southern California - an Innovative 'food As Medicine' Clinical Trial to Improve Food Insecurity and Health Among Medicaid Patients with Consistently Uncontrolled Type 2 Diabetes
The investigators are conducting a pre-randomized controlled trial to assess the effect of a 6 month Produce Prescription intervention for patients enrolled in Medicaid who experience consistently uncontrolled Hemoglobin A1c (HbA1c). The study is conducted at Kaiser Permanente Southern California, a large and diverse integrated health care system that serves 4.7 million members. Eligible participants are members aged 18 or older, currently enrolled in Medicaid who were diagnosed with diabetes for at least 24 months and had at least two Hba1c measurements of 7.5% or higher in the past 12 months. Patients in the intervention arm may enroll in tele nutrition counseling. The study team will recruit a total of 450. Participants, will be pre-randomized into one of three arms, 1) high dose intervention arm, a 2) low dose intervention and 3) a usual care group to achieve 150 participants enrolled in each arm. Produce is delivered weekly for participants of both intervention arms. Participants randomized to the high dose arm will receive a greater amount per month of produce versus the low dose amount (for a family of 3-4, $180 per month versus $135 respectively). Foods are provided along with recipes. The amount of food delivered is adjusted for each additional family member for up to 5 family members. The primary outcome is change in hemoglobin A1c pre-intervention and 6 months after enrollment. Secondary outcomes include, food insecurity status, dietary intake and other patient reported outcomes related to barriers to healthy eating including family conflict and cooking habits.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Produce prescription (weekly produce 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.
Produce prescription (weekly produce delivery)Other
Participants will receive weekly produce deliveries and recipes sent directly to their homes for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Intervention- High Dose | Active comparator | Participation will last approximately 6 months. Participants enrolled in the high-dose intervention arm will receive a weekly produce delivery directly to their home in addition to the completion of 3 questionnaires and collection of the HbA1c at the end of study. Receives: Other: Produce prescription (weekly produce delivery) |
| Intervention-Low Dose | Active comparator | Participation will last approximately 6 months. Participants enrolled in the low-dose intervention arm will receive a weekly produce delivery directly to their home in addition to the completion of 3 questionnaires and collection of the HbA1c at the end of study. The amount of produce provided in this arm will be lower per month per household size than the high dose arm. Receives: Other: Produce prescription (weekly produce delivery) |
| Usual Care | No intervention | Participation will last approximately 6 months. Participants enrolled in the Usual Care arm will complete 3 questionnaires and collection of the HbA1c at the end of study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c between baseline and 6 months
Both intervention and control participants will have their HbA1c tested at baseline and 6 months after the baseline assessment.
Measured: Baseline and 6 months after baseline assessment
Secondary outcomes (4)
Analyze the difference in difference of patient-reported food security between the intervention and control group.
Calculated by the change in self-reported food security using the US Adult Food Security Short Form (a six-item self-administered patient survey to identify food-insecure households and households with very low food security). Scores range from 0 (high or marginal food security) to 6 (very low food security).
Measured: Survey completed at Baseline, 3 months and 6 months
Analyze the difference in difference of patient-reported food-related self management between the intervention and control group.
Calculated by the change in self-reported food-related self management.
Measured: Survey completed at Baseline, 3 months and 6 months
Analyze the difference in difference of patient-reported diet quality between the intervention and control group.
Calculated by the change in self-reported food security using an adapted Rapid Eating Assessment of Participants Short form survey (REAP-S), which is a tool used to help care providers quickly assess a participant's diet.
Measured: Survey completed at Baseline, 3 months and 6 months
Analyze the difference in difference of patient-reported nutritional security between the intervention and control group.
Calculated by change in self-reported nutrition security.
Measured: Survey completed at Baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start11 Nov 2021
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 460 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 Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05407376
- Sponsor's protocol ID
- 12876
- Status last verified
- Mar 2025
- First submitted
- 8 Apr 2022
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nau C, Wu JHY, Han B, Habib M, Li X, Padilla A, Nelson C, Chao C, Schwartz P, Mozaffarian D. Effects of a "Food Is Medicine" Intervention on Glucose Control Among Medicaid-Insured Patients With Type 2 Diabetes: A Randomized Controlled Trial. Circulation. 2026 Aug 18;154(7):624-635. doi: 10.1161/CIRCULATIONAHA.125.077982. Epub 2026 Jul 21.
PubMed 42478360
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Produce Prescriptions At Kaiser Permanente Southern California - an Innovative 'food As Medicine' Clinical Trial to Improve Food Insecurity and Health Among Medicaid Patients with Consistently Uncontrolled Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05407376
- Acronym / sponsor ID
- 12876
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 7 Jun 2022 (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 investigators are conducting a pre-randomized controlled trial to assess the effect of a 6 month Produce Prescription intervention for patients enrolled in Medicaid who experience consistently uncontrolled Hemoglobin A1c (HbA1c). The study is conducted at Kaiser Permanente Southern California, a large and diverse integrated health care system that serves 4.7 million members. Eligible participants are members aged 18 or older, currently enrolled in Medicaid who were diagnosed with diabetes for at least 24 months and had at least two Hba1c measurements of 7.5% or higher in the past 12 months. Patients in the intervention arm may enroll in tele nutrition counseling. The study team will recruit a total of 450. Participants, will be pre-randomized into one of three arms, 1) high dose intervention arm, a 2) low dose intervention and 3) a usual care group to achieve 150 participants enrolled in each arm. Produce is delivered weekly for participants of both intervention arms. Participants randomized to the high dose arm will receive a greater amount per month of produce versus the low dose amount (for a family of 3-4, $180 per month versus $135 respectively). Foods are provided along with recipes. The amount of food delivered is adjusted for each additional family member for up to 5 family members. The primary outcome is change in hemoglobin A1c pre-intervention and 6 months after enrollment. Secondary outcomes include, food insecurity status, dietary intake and other patient reported outcomes related to barriers to healthy eating including family conflict and cooking habits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention- High Dose | Active comparator | Other: Produce prescription (weekly produce delivery)Participation will last approximately 6 months. Participants enrolled in the high-dose intervention arm will receive a weekly produce delivery directly to their home in addition to the completion of 3 questionnaires and collection of the HbA1c at the end of study. |
| Intervention-Low Dose | Active comparator | Other: Produce prescription (weekly produce delivery)Participation will last approximately 6 months. Participants enrolled in the low-dose intervention arm will receive a weekly produce delivery directly to their home in addition to the completion of 3 questionnaires and collection of the HbA1c at the end of study. The amount of produce provided in this arm will be lower per month per household size than the high dose arm. |
| Usual Care | No intervention | –Participation will last approximately 6 months. Participants enrolled in the Usual Care arm will complete 3 questionnaires and collection of the HbA1c at the end of study. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years of age or older
- Diagnosed with Type 2 Diabetes for at least 24 months
- Diagnosed with Type 2 Diabetes and have at least two HbA1cs of 7.5% or higher in 12 months prior to recruitment
- Have MediCaid insurance at the time of their last hba1c test
- Will be able to provide informed consent
Key exclusion criteria (3 listed)
- Pregnant women
- Living in a board and care where your meals are provided for you
- Unable to provide informed consent
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 |
|---|---|---|
| Produce prescription (weekly produce delivery)Participants will receive weekly produce deliveries and recipes sent directly to their homes for 6 months. | Other | Intervention- High Dose, Intervention-Low Dose |
Primary outcome
Change in HbA1c between baseline and 6 months
Time frame: Baseline and 6 months after baseline assessment
Both intervention and control participants will have their HbA1c tested at baseline and 6 months after the baseline assessment.
4 secondary outcomes
Analyze the difference in difference of patient-reported food security between the intervention and control group.
Time frame: Survey completed at Baseline, 3 months and 6 months
Analyze the difference in difference of patient-reported food-related self management between the intervention and control group.
Time frame: Survey completed at Baseline, 3 months and 6 months
Analyze the difference in difference of patient-reported diet quality between the intervention and control group.
Time frame: Survey completed at Baseline, 3 months and 6 months
Analyze the difference in difference of patient-reported nutritional security between the intervention and control group.
Time frame: Survey completed at Baseline, 3 months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Derived from this study: PubMed 42478360Nau C, Wu JHY, Han B, Habib M, Li X, Padilla A, Nelson C, Chao C, Schwartz P, Mozaffarian D. Effects of a "Food Is Medicine" Intervention on Glucose Control Among Medicaid-Insured Patients With Type 2 Diabetes: A Randomized Controlled Trial. Circulation. 2026 Aug 18;154(7):624-635. doi: 10.1161/CIRCULATIONAHA.125.077982. Epub 2026 Jul 21.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Produce prescription (weekly produce delivery) in people with Diabetes Mellitus, Type 2, run by Kaiser Permanente at 1 site 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 7 inclusion and 3 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: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in HbA1c between baseline and 6 months (time frame: Baseline and 6 months after baseline assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05407376, which also lists 1 linked publication.
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 24 Mar 2025.