CClinicalTrials.gg
CompletedNCT06214806FIMUpdated Dec 2, 2024

Food Is Medicine: Makin' Healthy Groceries

An interventional study of Grocery Vouchers in Hypertension, sponsored by Duke University. Completed at 2 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-12-02.

Sponsored by Duke University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
97
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Hypertension

Browse trials for

Keywords

  • Food Insecurity
  • Food As Medicine
  • American Heart Association (AHA)
  • New Orleans
  • Louisiana
  • PCORnet
  • Electronic Health Record (EHR)
  • Cardiovascular Disease
  • Hypertension
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 97 is close to the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
97 participants (actual)

Study arms

  • Experimental
    Instacart

    Voucher for grocery purchase and delivery via Instacart

    Behavioral: Grocery Vouchers

  • Active comparator
    Rouses Market

    Voucher for grocery purchase in-person at Rouses Market in New Orleans

    Behavioral: Grocery Vouchers

Interventions

  • BehavioralGrocery Vouchers

    Participants will be given vouchers to buy groceries each month for five months.

06

What researchers measure

Primary outcomes

  1. Change in food consumption

    Self-reported consumption of servings of fruits and vegetables combined, assessed through food frequency questionnaire

    Time frame: Baseline, every month for 5 months

Secondary outcomes

  1. Change in food purchasing

    Imputed dollar amount spent on fruits and vegetables, derived from purchasing data

    Time frame: Every month, between months 1-5

  2. Use of voucher

    Average dollar amount of voucher spent per month

    Time frame: Every month, between months 1-5

07

Study locations

2 sites
  • University Medical Center New Orleans - LCMC Health
    New Orleans, Louisiana 70112, United States
  • Louisiana Public Health Institute (LPHI)
    New Orleans, Louisiana 70130, United States
08

References and documents

Related links

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06214806
Lead sponsor
Duke University
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
First posted
Jan 22, 2024
Start date
Mar 12, 2024
Primary completion
Oct 20, 2024
Completion
Oct 23, 2024
Last update
Dec 2, 2024

Study contacts

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)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion