Addressing Food Insecurity: Plant-Based Food Prescription Program

Official title

Addressing Food-Insecurity: Plant-Based Food Prescription Program to Improve Health Food Access

Overview

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.

Interventions

• Other Plant-Based Food Provision (with or without food prescription)
  Food Prescription: Participants will bring the food prescription obtained from the nutrition class to Village FREEdge, food pantry at the Freedom Lab, where it will function as a voucher. Each voucher will allow for participants to pick up enough plant-based food for 6 meals per person in their household (with household maximum of 5 people)(enough meals for 3 days- 2 meals per person per day). We expect that participants will pick up food twice per week from Village FREEdge to obtain enough meal
• Other Plant-Based Nutrition Education
  A once weekly classes for a 5-week nutrition course. The parents/guardians would bring their children and any additional household member(s) to the nutrition class, which will organize participants in different classrooms by age (children 4 years, 4-12 years old, 12-14 years old, 14+ years old). Each classrooms will engage in age-appropriate interactive nutrition-based activities. All children below 18 will engage in interactive activities for the full 1.5 hours. Adolescents aged 14 up will join

Primary outcome measures

• Number of Servings of Unprocessed and Minimally Processed Fruits and Vegetables [Time frame: Up to 1 year]
• Number of Servings of Unprocessed and Minimally Processed Whole Grains [Time frame: Up to 1 year]
• Number of Servings of Unprocessed and Minimally Processed Legumes [Time frame: Up to 1 year]
• Number Servings of Unprocessed and Minimally Processed Nuts/Seeds [Time frame: Up to 1 year]

Secondary outcome measures (2)

• Presence of Food Insecurity [Time frame: Up to 1 year]
• Change in Plant-Based Nutrition Knowledge of Participants [Time frame: Up to 1 year]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Health services research

Study locations

United States · 1 center

• Freedom Lab 4300 NW 12th Ave — Miami

Publications

• Bryce R, WolfsonBryce JA, CohenBryce A, Milgrom N, Garcia D, Steele A, Yaphe S, Pike D, Valbuena F, Miller-Matero LR. A pilot randomized controlled trial of a fruit and vegetable prescription program at a federally qualified health center in low income uncontrolled diabetics. Prev Med Rep. 2021 May 31;23:101410. doi: 10.1016/j.pmedr.2021.101410. eCollection 2021 Sep. PMID 34150472
• Ridberg RA, Bell JF, Merritt KE, Harris DM, Young HM, Tancredi DJ. Effect of a Fruit and Vegetable Prescription Program on Children's Fruit and Vegetable Consumption. Prev Chronic Dis. 2019 Jun 13;16:E73. doi: 10.5888/pcd16.180555. PMID 31198165
• Oronce CIA, Miake-Lye IM, Begashaw MM, Booth M, Shrank WH, Shekelle PG. Interventions to Address Food Insecurity Among Adults in Canada and the US: A Systematic Review and Meta-analysis. JAMA Health Forum. 2021 Aug 6;2(8):e212001. doi: 10.1001/jamahealthforum.2021.2001. eCollection 2021 Aug. PMID 35977189
• Bhat S, Coyle DH, Trieu K, Neal B, Mozaffarian D, Marklund M, Wu JHY. Healthy Food Prescription Programs and their Impact on Dietary Behavior and Cardiometabolic Risk Factors: A Systematic Review and Meta-Analysis. Adv Nutr. 2021 Oct 1;12(5):1944-1956. doi: 10.1093/advances/nmab039. PMID 33999108
• Xie J, Price A, Curran N, Ostbye T. The impact of a produce prescription programme on healthy food purchasing and diabetes-related health outcomes. Public Health Nutr. 2021 Aug;24(12):3945-3955. doi: 10.1017/S1368980021001828. Epub 2021 Apr 27. PMID 33902771
• Fuchs D. An overview of nutrition in medical education. JAMA. 2018;319(15):1551. doi:10.1001/jama.2018.1919.
• Centers for Disease Control and Prevention. Chronic disease prevention. Accessed January 23, 2024. Available from: https://www.cdc.gov/chronic-disease/prevention/
• Stanford Medicine. Why medical schools need to focus on nutrition. Accessed January 23, 2024. Available from: https://med.stanford.edu/school/leadership/dean/precision-health-in-the-news/why-medica-schools-need-focus-nutrition.html

Identifiers

NCT: NCT06614920 · 20240753

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗