Food Is Medicine: Makin' Healthy Groceries

NCT ID: NCT06214806

Last Updated: 2024-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-12

Study Completion Date

2024-10-23

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Food delivered via Instacart versus comparator arm of food purchased in-person at Rouses Market
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

No masking

Study Groups

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Instacart

Voucher for grocery purchase and delivery via Instacart

Group Type EXPERIMENTAL

Grocery Vouchers

Intervention Type BEHAVIORAL

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

Rouses Market

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

Group Type ACTIVE_COMPARATOR

Grocery Vouchers

Intervention Type BEHAVIORAL

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

Interventions

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Grocery Vouchers

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

Rouses Market

UNKNOWN

Sponsor Role collaborator

Instacart

UNKNOWN

Sponsor Role collaborator

Duke Clinical Research Institute

OTHER

Sponsor Role collaborator

University Medical Center New Orleans - LCMC Health

UNKNOWN

Sponsor Role collaborator

Louisiana Public Health Institute

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adrian Hernandez, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Duke Clinical Research Institute

Thomas W Carton, PhD, MS

Role: STUDY_DIRECTOR

Louisiana Public Health Institute (LPHI)

Bridget Simon-Friedt

Role: STUDY_CHAIR

Louisiana Public Health Institute (LPHI)

Locations

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University Medical Center New Orleans - LCMC Health

New Orleans, Louisiana, United States

Site Status

Louisiana Public Health Institute (LPHI)

New Orleans, Louisiana, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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Pro00114628

Identifier Type: -

Identifier Source: org_study_id