Food Is Medicine: Makin' Healthy Groceries (FIM)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Grocery Vouchers

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Madeline Young, MS; Phone Number: 504-702-2440; Email: Madeline.Young@lcmchealth.org
• Study Contact Backup: Name: Bridget Simon-Friedt, PhD, MS; Phone Number: (504) 301-9800; Email: bSimon-Friedt@lphi.org

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • University Medical Center New Orleans - LCMC Health
      • Contact: Madeline Young, MS; Phone Number: 504-702-2440; Email: Madeline.Young@lcmchealth.org
      • Contact: Yuriy Bisyuk, MD, PhD, DSc; Phone Number: 504-702-3143; Email: yuriy.bisyuk@lcmchealth.org
      • Principal Investigator: Yuriy Bisyuk, MD, PhD, DSc
    • New Orleans, Louisiana, United States, 70130
      • Louisiana Public Health Institute (LPHI)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Instacart; Voucher for grocery purchase and delivery via Instacart	Behavioral: Grocery Vouchers; Participants will be given vouchers to buy groceries each month for five months.
Active Comparator: Rouses Market; Voucher for grocery purchase in-person at Rouses Market in New Orleans	Behavioral: Grocery Vouchers; Participants will be given vouchers to buy groceries each month for five months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in food consumption	Self-reported consumption of servings of fruits and vegetables combined, assessed through food frequency questionnaire	Baseline, every month for 5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in food purchasing	Imputed dollar amount spent on fruits and vegetables, derived from purchasing data	Every month, between months 1-5
Use of voucher	Average dollar amount of voucher spent per month	Every month, between months 1-5

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: American Heart Association; Duke Clinical Research Institute; Louisiana Public Health Institute; Rouses Market; Instacart; University Medical Center New Orleans - LCMC Health
• Investigators: Principal Investigator: Adrian Hernandez, MD, MHS, Duke Clinical Research Institute; Study Director: Thomas W Carton, PhD, MS, Louisiana Public Health Institute (LPHI); Study Chair: Bridget Simon-Friedt, Louisiana Public Health Institute (LPHI)

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: January 10, 2024
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Hypertension; Cardiovascular Disease; Food Insecurity; Electronic Health Record (EHR); New Orleans; Louisiana; Food As Medicine; American Heart Association (AHA); PCORnet
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: Pro00114628

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No