Food Is Medicine: Makin' Healthy Groceries

NCT06214806 | Completed

• 1 other identifier: Pro00114628
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in food purchasing

  Every month, between months 1-5

• Use of voucher

  Every month, between months 1-5

Study Arms (2)

Instacart

EXPERIMENTAL

Voucher for grocery purchase and delivery via Instacart

Behavioral: Grocery Vouchers

Rouses Market

ACTIVE COMPARATOR

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

Behavioral: Grocery Vouchers

Interventions

Grocery Vouchers BEHAVIORAL

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

Instacart; Rouses Market

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• American Heart Association: collaborator
• Rouses Market: collaborator
• Instacart: collaborator
• Duke Clinical Research Institute: collaborator
• University Medical Center New Orleans - LCMC Health: collaborator
• Louisiana Public Health Institute: collaborator

Study Sites (2)

University Medical Center New Orleans - LCMC Health

New Orleans, Louisiana, 70112, United States

Location

Louisiana Public Health Institute (LPHI)

New Orleans, Louisiana, 70130, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

• Adrian Hernandez, MD, MHS

  Duke Clinical Research Institute

  PRINCIPAL INVESTIGATOR

• Thomas W Carton, PhD, MS

  Louisiana Public Health Institute (LPHI)

  STUDY DIRECTOR

• Bridget Simon-Friedt

  Louisiana Public Health Institute (LPHI)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Food delivered via Instacart versus comparator arm of food purchased in-person at Rouses Market

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 22, 2024
• Study Start: March 12, 2024
• Primary Completion: October 20, 2024
• Study Completion: October 23, 2024
• Last Updated: December 2, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)