HypertensionFIMNCT06214806
Food Is Medicine: Makin' Healthy Groceries
A study testing Grocery Vouchers in people with Hypertension, run by Duke University at 2 sites in United States.
Trial summary
This is a minimal risk study focusing on food purchasing and consumption in 100 subjects in the greater New Orleans area. There is evidence showing that individually-targeted vouchers effectively increase category-level food purchases in both less healthful and more healthful categories. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Grocery Vouchers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Mar 2024to 23 Oct 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Greater than or equal to 50 years of age
- Uncontrolled hypertension (defined as at least two clinically documented blood pressure readings of systolic BP >= 140 AND diastolic BP >=90 in the prior 6 months)
- Understands English
Who cannot join
- No internet access (at home, library, relative, or though phone plan)
- No adequate transportation (personal car, reliable ride, bus, and/or Uber/Lyft) in the New Orleans area
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University Medical Center New Orleans - LCMC Health
New Orleans, Louisiana, 70112
Louisiana Public Health Institute (LPHI)
New Orleans, Louisiana, 70130
About this study
Official title: Impact of a Food Purchasing Intervention on Consumption Patterns and Improved Dietary Outcomes in New Orleans - Food Is Medicine
This is a minimal risk study focusing on food purchasing and consumption in 100 subjects in the greater New Orleans area. There is evidence showing that individually-targeted vouchers effectively increase category-level food purchases in both less healthful and more healthful categories. This pilot study will investigate whether a voucher program using Instacart or a local, brick-and-mortar supermarket in New Orleans, LA lead to changes in food purchasing patterns, food consumption, food insecurity, and access to healthy food options for the participants, who are at risk of cardiovascular disease and/or cardiac complications. The study will also measure concordance between food purchasing and actual consumption.
- Conditions
- Hypertension
- Being tested
- Grocery Vouchers
- Keywords
- Food Insecurity, Food As Medicine, American Heart Association (AHA), New Orleans, Louisiana, PCORnet, Electronic Health Record (EHR), Cardiovascular Disease, Hypertension
- Medical subject headings
- Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grocery VouchersBehavioural
Participants will be given vouchers to buy groceries each month for five months.
| Study group | Role | What they receive |
|---|---|---|
| Instacart | Experimental | Voucher for grocery purchase and delivery via Instacart Receives: Behavioral: Grocery Vouchers |
| Rouses Market | Active comparator | Voucher for grocery purchase in-person at Rouses Market in New Orleans Receives: Behavioral: Grocery Vouchers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in food consumption
Self-reported consumption of servings of fruits and vegetables combined, assessed through food frequency questionnaire
Measured: Baseline, every month for 5 months
Secondary outcomes (2)
Change in food purchasing
Imputed dollar amount spent on fruits and vegetables, derived from purchasing data
Measured: Every month, between months 1-5
Use of voucher
Average dollar amount of voucher spent per month
Measured: Every month, between months 1-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start12 Mar 2024
- Primary completion20 Oct 2024
- Study completion23 Oct 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 HypertensionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Model description
- Food delivered via Instacart versus comparator arm of food purchased in-person at Rouses Market
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association, Rouses Market, Instacart, Duke Clinical Research Institute, University Medical Center New Orleans - LCMC Health, Louisiana Public Health Institute
- Responsible party
- Sponsor
- Investigators
- Adrian Hernandez, MD, MHS, Principal investigator, Duke Clinical Research InstituteThomas W Carton, PhD, MS, Study director, Louisiana Public Health Institute (LPHI)Bridget Simon-Friedt, Study chair, Louisiana Public Health Institute (LPHI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214806
- Sponsor's protocol ID
- Pro00114628
- Acronym
- FIM
- Status last verified
- Jul 2024
- First submitted
- 10 Jan 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tannu M, Young R, Brucker A, Simon-Friedt B, Bisyuk Y, Tumusiime S, Rudov L, Stein J, Alley M, Hannagan D, Young M, McGary J, Palmer S, Cohen L, Pagidipati N, Hernandez A, Carton TW. Pilot Randomized Trial of 2 Food Purchasing Interventions in Individuals With Hypertension in New Orleans: An American Heart Association Food Is Medicine Initiative. J Am Heart Assoc. 2026 Oct 10:e044984. doi: 10.1161/JAHA.125.044984. Online ahead of print.
PubMed 42858008
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Food Purchasing Intervention on Consumption Patterns and Improved Dietary Outcomes in New Orleans - Food Is Medicine
- ClinicalTrials.gov ID
- NCT06214806
- Acronym / sponsor ID
- FIM / Pro00114628
- Conditions
- Hypertension
- Keywords
- Food Insecurity, Food As Medicine, American Heart Association (AHA), New Orleans, Louisiana, PCORnet, Electronic Health Record (EHR), Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- American Heart Association, Rouses Market, Instacart, Duke Clinical Research Institute, University Medical Center New Orleans - LCMC Health, Louisiana Public Health Institute
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 20 Oct 2024 (actual)
- Study completion
- 23 Oct 2024 (actual)
- First posted
- 22 Jan 2024 (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.
This is a minimal risk study focusing on food purchasing and consumption in 100 subjects in the greater New Orleans area. There is evidence showing that individually-targeted vouchers effectively increase category-level food purchases in both less healthful and more healthful categories. This pilot study will investigate whether a voucher program using Instacart or a local, brick-and-mortar supermarket in New Orleans, LA lead to changes in food purchasing patterns, food consumption, food insecurity, and access to healthy food options for the participants, who are at risk of cardiovascular disease and/or cardiac complications. The study will also measure concordance between food purchasing and actual consumption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Food delivered via Instacart versus comparator arm of food purchased in-person at Rouses Market
| Arm | Type | Receives |
|---|---|---|
| Instacart | Experimental | Behavioral: Grocery VouchersVoucher for grocery purchase and delivery via Instacart |
| Rouses Market | Active comparator | Behavioral: Grocery VouchersVoucher for grocery purchase in-person at Rouses Market in New Orleans |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Greater than or equal to 50 years of age
- Uncontrolled hypertension (defined as at least two clinically documented blood pressure readings of systolic BP >= 140 AND diastolic BP >=90 in the prior 6 months)
- Understands English
Key exclusion criteria (2 listed)
- No internet access (at home, library, relative, or though phone plan)
- No adequate transportation (personal car, reliable ride, bus, and/or Uber/Lyft) in the New Orleans area
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 |
|---|---|---|
| Grocery VouchersParticipants will be given vouchers to buy groceries each month for five months. | Behavioural | Instacart, Rouses Market |
Primary outcome
Change in food consumption
Time frame: Baseline, every month for 5 months
Self-reported consumption of servings of fruits and vegetables combined, assessed through food frequency questionnaire
2 secondary outcomes
Change in food purchasing
Time frame: Every month, between months 1-5
Use of voucher
Time frame: Every month, between months 1-5
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 2 Dec 2024.
- Derived from this study: PubMed 42858008Tannu M, Young R, Brucker A, Simon-Friedt B, Bisyuk Y, Tumusiime S, Rudov L, Stein J, Alley M, Hannagan D, Young M, McGary J, Palmer S, Cohen L, Pagidipati N, Hernandez A, Carton TW. Pilot Randomized Trial of 2 Food Purchasing Interventions in Individuals With Hypertension in New Orleans: An American Heart Association Food Is Medicine Initiative. J Am Heart Assoc. 2026 Oct 10:e044984. doi: 10.1161/JAHA.125.044984. Online ahead of print.
- Related InfoLink provided by the sponsor.
- 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.
Adrian Hernandez, MD, MHS principal investigator
Duke Clinical Research Institute
Thomas W Carton, PhD, MS study director
Louisiana Public Health Institute (LPHI)
Bridget Simon-Friedt study chair
Louisiana Public Health Institute (LPHI)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grocery Vouchers in people with Hypertension, run by Duke University 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 3 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: finished, as of the sponsor's last update on 2 Dec 2024. 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?
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 food consumption (time frame: Baseline, every month for 5 months). 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 NCT06214806, 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 2 Dec 2024.