Food Is Medicine: Makin' Healthy Groceries (FIM)

November 27, 2024 updated by: Duke University

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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Baseline, every month for 5 months
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
Time Frame: Every month, between months 1-5
Imputed dollar amount spent on fruits and vegetables, derived from purchasing data
Every month, between months 1-5
Use of voucher
Time Frame: Every month, between months 1-5
Average dollar amount of voucher spent per month
Every month, between months 1-5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2024

Primary Completion (Actual)

October 20, 2024

Study Completion (Actual)

October 23, 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 (Estimated)

December 2, 2024

Last Update Submitted That Met QC Criteria

November 27, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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