Clinical trial NCT06614920: Addressing Food Insecurity: Plant-Based Food Prescription Program
Official title: Addressing Food-Insecurity: Plant-Based Food Prescription Program to Improve Health Food Access
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Health Literacy
Nutrition, Healthy
Nutrition Poor
Food Insecurity
Food Insecurity Among Children
Low Income Population
Keywords: Plant-based food prescription program
Plant-based
Food prescription
Food insecurity
Poverty
Nutrition education
Plant-based nutrition literacy
Plant-based nutrition education
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: American Academy of Pediatrics
name: Committee of Interns and Residents SEIU Healthcare
First posted: 2024-09-26
Enrollment: 100
Sex: ALL
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Reduce food insecurity by improving plant-based health food consumption, access, health and nutrition literacy and the health of the food-insecure families we serve.


Eligibility criteria: Inclusion Criteria:

* Participants will be all ages 0-99 (all arms)
* Families living under the federal poverty line AND who have food insecurity (all arms except Arm 2 which can include families with income above the federal poverty line who do not have food insecurity).
* Families cared for in either the Pediatric Mobile Clinic, Pediatric, Family Medicine, Internal Medicine or Med-Peds primary care clinics in the UHealth/Jackson Health System/Dade County Street Response.

Exclusion Criteria:

* Families who are not under the federal poverty line AND are not food insecure (all arms except Arm 2, which will include participants of all socioeconomic statuses and regardless of food security status, with no exclusion criteria in this category).
* Families who are not actively receiving outpatient primary care (all arms).

Primary outcomes:
measure: Number of Servings of Unprocessed and Minimally Processed Fruits and Vegetables
timeFrame: Up to 1 year
measure: Number of Servings of Unprocessed and Minimally Processed Whole Grains
timeFrame: Up to 1 year
measure: Number of Servings of Unprocessed and Minimally Processed Legumes
timeFrame: Up to 1 year
measure: Number Servings of Unprocessed and Minimally Processed Nuts/Seeds
timeFrame: Up to 1 year
Secondary outcomes:
measure: Presence of Food Insecurity
timeFrame: Up to 1 year
measure: Change in Plant-Based Nutrition Knowledge of Participants
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Miami
country: United States
facility: Freedom Lab 4300 NW 12th Ave
state: Florida
Study officials:
affiliation: University of Miami
name: Azaria V Lewis, DO
role: PRINCIPAL_INVESTIGATOR
References:
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