Food Is Medicine: Makin' Healthy Groceries

Hypertension Clinical Trial

— FIM  

Official title:

Impact of a Food Purchasing Intervention on Consumption Patterns and Improved Dietary Outcomes in New Orleans - Food Is Medicine

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06214806
• Other study ID #: Pro00114628
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 12, 2024
• Est. completion date: September 2024

Study information

• Verified date: March 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• Grocery Vouchers
Participants will be given vouchers to buy groceries each month for five months.

Locations

Country	Name	City	State
United States	Louisiana Public Health Institute (LPHI)	New Orleans	Louisiana
United States	University Medical Center New Orleans - LCMC Health	New Orleans	Louisiana

Sponsors (7)

Lead Sponsor	Collaborator
Duke University	American Heart Association, Duke Clinical Research Institute, Instacart, Louisiana Public Health Institute, Rouses Market, University Medical Center New Orleans - LCMC Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in food purchasing	Imputed dollar amount spent on fruits and vegetables, derived from purchasing data	Every month, between months 1-5
Secondary	Use of voucher	Average dollar amount of voucher spent per month	Every month, between months 1-5