Type 2 Diabetes MellitusNCT06033664
Grocery Prescription Program for Medicaid Adults With Hypertension or Type 2 Diabetes
A study testing Fresh Funds in people with Type 2 Diabetes Mellitus and Hypertension, run by Alison Gustafson at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of a grocery prescription program in adults diagnosed with either Type 2 Diabetes Mellitus or Hypertension. Participants will enroll in Instacart Fresh Funds program. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Hypertension
- What is being tested?
- Fresh Funds
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2023to 8 May 2024
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of Type 2 Diabetes Mellitus, hemoglobin A1c = 7.0% and = 12.0% in last 12 months, or diagnosis of hypertension
- Experiencing food insecurity as indicated by 2-item Hunger Vital Sign
- English speaking
- No plans to move from the area for at least 1 year
- Willing and able to accept text messages
- Free living to the extent that participant has control over dietary intake
- Willing and able to provide written informed consent and participate in all study activities.
Who cannot join
- Participant in diabetes, nutrition, or weight research intervention in last 12 months
- Another member of the household is already enrolled in this study
- Considering bariatric surgery in the next year or prior bariatric surgery
- Lack of safe, stable residence and ability to store meals
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the effectiveness of a grocery prescription program in adults diagnosed with either Type 2 Diabetes Mellitus or Hypertension. Participants will enroll in Instacart Fresh Funds program. Once enrolled each week participants will select foods that are eligible in the Fresh Funds Program to be delivered to their home for 12 weeks. Participants will also participate in a survey at the beginning of the study and at the end of the study.
- Conditions
- Type 2 Diabetes Mellitus, Hypertension
- Being tested
- Fresh Funds
- Keywords
- Food Insecurity, Food as Medicine, Medicaid Adults
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresh FundsBehavioural
Also called Grocery Prescription Program; Food As Medicine
Participants will enroll in Instacart Fresh Funds program. Once enrolled participants will select foods that are eligible in the Fresh Funds to be delivered to their home each week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Grocery Prescription Program | Experimental | Participants will receive the Fresh Funds through Instacart Receives: Behavioral: Fresh Funds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with a percentage change in Hemoglobin A1C (HbgA1C)
HbgA1C will be obtained baseline and post intervention by the healthcare provider from the medical chart.
Measured: baseline and post intervention, approximately 12 weeks
Secondary outcomes (2)
Change in blood pressure
Both systolic and diastolic blood pressure will be obtained baseline and post intervention by the healthcare provider from the medical chart.
Measured: baseline and post intervention, approximately 12 weeks
Change in food insecurity
The USDA 6 item food insecurity screener will be used. The scale ranges from 0 to 6 with a higher score indicating greater food insecurity.
Measured: baseline and post intervention, approximately 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start6 Nov 2023
- Primary completion8 May 2024
- Study completion8 May 2024
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 Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alison Gustafson
- Sponsor type
- University, hospital or other
- Collaborators
- Instacart Health, Kentucky Association of Health Plans
- Responsible party
- Sponsor-investigator, Alison Gustafson, University of Kentucky
- Investigators
- Alison Gustafson, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033664
- Sponsor's protocol ID
- 88696
- Status last verified
- May 2024
- First submitted
- 5 Sep 2023
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mayfield C, Lauckner C, Bush J, Cosson E, Batey L, Gustafson A. Development of a statewide network hub for screening, referral, and enrollment into food as medicine programs across Kentucky. Front Public Health. 2025 Jan 7;12:1502858. doi: 10.3389/fpubh.2024.1502858. eCollection 2024.
PubMed 39845669
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Grocery Prescription Program for Medicaid Adults With Hypertension or Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06033664
- Acronym / sponsor ID
- 88696
- Conditions
- Type 2 Diabetes Mellitus, Hypertension
- Keywords
- Food Insecurity, Food as Medicine, Medicaid Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Alison GustafsonUniversity, hospital or other
- Collaborators
- Instacart Health, Kentucky Association of Health Plans
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 8 May 2024 (actual)
- Study completion
- 8 May 2024 (actual)
- First posted
- 13 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 purpose of this study is to evaluate the effectiveness of a grocery prescription program in adults diagnosed with either Type 2 Diabetes Mellitus or Hypertension. Participants will enroll in Instacart Fresh Funds program. Once enrolled each week participants will select foods that are eligible in the Fresh Funds Program to be delivered to their home for 12 weeks. Participants will also participate in a survey at the beginning of the study and at the end of the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Grocery Prescription Program | Experimental | Behavioral: Fresh FundsParticipants will receive the Fresh Funds through Instacart |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Diagnosis of Type 2 Diabetes Mellitus, hemoglobin A1c = 7.0% and = 12.0% in last 12 months, or diagnosis of hypertension
- Experiencing food insecurity as indicated by 2-item Hunger Vital Sign
- English speaking
- No plans to move from the area for at least 1 year
- Willing and able to accept text messages
Key exclusion criteria (4 listed)
- Participant in diabetes, nutrition, or weight research intervention in last 12 months
- Another member of the household is already enrolled in this study
- Considering bariatric surgery in the next year or prior bariatric surgery
- Lack of safe, stable residence and ability to store meals
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 |
|---|---|---|
| Fresh FundsAlso: Grocery Prescription Program; Food As MedicineParticipants will enroll in Instacart Fresh Funds program. Once enrolled participants will select foods that are eligible in the Fresh Funds to be delivered to their home each week for 12 weeks. | Behavioural | Grocery Prescription Program |
Primary outcome
Number of participants with a percentage change in Hemoglobin A1C (HbgA1C)
Time frame: baseline and post intervention, approximately 12 weeks
HbgA1C will be obtained baseline and post intervention by the healthcare provider from the medical chart.
2 secondary outcomes
Change in blood pressure
Time frame: baseline and post intervention, approximately 12 weeks
Change in food insecurity
Time frame: baseline and post intervention, approximately 12 weeks
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 10 May 2024.
- Derived from this study: PubMed 39845669Mayfield C, Lauckner C, Bush J, Cosson E, Batey L, Gustafson A. Development of a statewide network hub for screening, referral, and enrollment into food as medicine programs across Kentucky. Front Public Health. 2025 Jan 7;12:1502858. doi: 10.3389/fpubh.2024.1502858. eCollection 2024.
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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.
Alison Gustafson, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fresh Funds in people with Type 2 Diabetes Mellitus and Hypertension, run by Alison Gustafson 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 4 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 10 May 2024. 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?
Number of participants with a percentage change in Hemoglobin A1C (HbgA1C) (time frame: baseline and post intervention, approximately 12 weeks). 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 NCT06033664, 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 10 May 2024.