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OpenTrials
Completed

NCT Number: NCT06214806

Food Is Medicine: Makin' Healthy Groceries

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Louisiana Public Health Institute (LPHI), New Orleans, Louisiana, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Grocery Vouchers

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Change in food purchasing

    Time frame: Every month, between months 1-5

    Imputed dollar amount spent on fruits and vegetables, derived from purchasing data

  2. Use of voucher

    Time frame: Every month, between months 1-5

    Average dollar amount of voucher spent per month

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: FIM

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 22, 2024
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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