Comparison of Produce Prescription Benefit Dosage

Comparison of Produce Prescription Benefit Dosage on Redemption

The goal of this study is to determine the relationship between produce prescription program 'dose' on benefit redemption, food insecurity, and fruit and vegetable consumption. Participants will be randomized to receive one of three fruit and vegetable benefit dose amounts for 6 months ($40, $80, or $110/month).

Study Overview

• Status: Not yet recruiting
• Conditions: Food Insecurity
• Intervention / Treatment: Behavioral: Monetary benefit to purchase fruits and vegetables

Detailed Description

Emerging evidence from the growing body of research around 'Food is Medicine' interventions shows promise that produce prescriptions (PPR) improve health by enabling purchases of healthy foods, reducing food insecurity, and improving diet quality. However, PPR amounts are often set seemingly arbitrarily, without clear connection to their intended purpose. In this study, investigators will conduct a three-armed randomized trial of 240 participants in Stockton, CA to test the impact of three 'doses' of a fruit and vegetable benefit on benefit redemption, food security, and fruit and vegetable intake. The goal of this study is to determine the relationship between PPR program 'dose' and the key intermediate outcomes of benefit redemption (primary outcome), food insecurity, and consumption of incentivized foods (secondary outcomes). Investigators will also seek to identify any 'ceiling effect' above which further increases in benefit value do not lead to further benefit redemption. This will be highly informative for subsequent PPR research. Investigators will leverage the existing infrastructure of the Vouchers 4 Veggies - EatSF produce prescription program to ensure feasibility.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hilary Seligman, MD, MAS; Phone Number: (628) 206-4448; Email: hilary.seligman@ucsf.edu
• Study Contact Backup: Name: Ronli Levi, MPH, RD; Phone Number: 510-847-1951; Email: ronli.levi@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • University of California, San Francisco
      • Contact: Ronli Levi, MPH, RD; Phone Number: 510-847-1951; Email: ronli.levi@ucsf.edu
      • Contact: Hilary Seligman, MD, MAS; Phone Number: 628-206-4448; Email: hilary.seligman@ucsf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Individual receiving services at El Concilio, located in Stockton, CA
• Age 18+
• English or Spanish speaking
• Literacy sufficient to complete a written survey
• Technologic capacity to complete an online survey

Exclusion Criteria:

• non English or Spanish speaking
• cognitive impairment severe enough to interfere with understanding of the survey or consent form, whether due to cognitive delay, substance abuse, dementia, mental illness, or other etiologies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1 - 10% TFP; Participants will receive $40/month in fruit and vegetable benefits for 6 months ($240 total).	Behavioral: Monetary benefit to purchase fruits and vegetables; Participants will receive varying benefit amounts to purchase fruits and vegetables.
Active Comparator: Arm 2 - 20% TFP; Participants will receive $80/month in fruit and vegetable benefits for 6 months ($480 total).	Behavioral: Monetary benefit to purchase fruits and vegetables; Participants will receive varying benefit amounts to purchase fruits and vegetables.
Active Comparator: Arm 3 - 30% TFP; Participants will receive $110/month in fruit and vegetable benefits for 6 months ($660).	Behavioral: Monetary benefit to purchase fruits and vegetables; Participants will receive varying benefit amounts to purchase fruits and vegetables.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Benefit redemption	Dollar amount of benefits redeemed (numerator) over total dollar amount of benefits distributed (denominator)	Monthly for 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fruit and vegetable consumption	Measured by NCI Dietary Screener Questionnaire (DSQ) and reported in cup-equivalents, a higher score indicates greater fruit and vegetable intake (better outcome)	0, 3, and 6 months
Food security status	Measured by USDA 6-item food security module, scale of 0-6, a higher score indicates more severe food insecurity (worse outcome); Scores converted to Rasch measurement scale, scale of 0-8.48, a higher score indicates more severe food insecurity	0, 3, and 6 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: American Heart Association
• Investigators: Principal Investigator: Hilary Seligman, MD, MAS, University of California, San Francisco

Publications and helpful links

General Publications

• 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.
• Berkowitz SA, Baggett TP, Wexler DJ, Huskey KW, Wee CC. Food insecurity and metabolic control among U.S. adults with diabetes. Diabetes Care. 2013 Oct;36(10):3093-9. doi: 10.2337/dc13-0570. Epub 2013 Jun 11.
• Seligman HK, Laraia BA, Kushel MB. Food insecurity is associated with chronic disease among low-income NHANES participants. J Nutr. 2010 Feb;140(2):304-10. doi: 10.3945/jn.109.112573. Epub 2009 Dec 23. Erratum In: J Nutr. 2011 Mar;141(3):542.
• 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.
• Ridberg RA, Levi R, Marpadga S, Akers M, Tancredi DJ, Seligman HK. Additional Fruit and Vegetable Vouchers for Pregnant WIC Clients: An Equity-Focused Strategy to Improve Food Security and Diet Quality. Nutrients. 2022 Jun 1;14(11):2328. doi: 10.3390/nu14112328.
• Stotz SA, Budd Nugent N, Ridberg R, Byker Shanks C, Her K, Yaroch AL, Seligman H. Produce prescription projects: Challenges, solutions, and emerging best practices - Perspectives from health care providers. Prev Med Rep. 2022 Aug 13;29:101951. doi: 10.1016/j.pmedr.2022.101951. eCollection 2022 Oct.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 17, 2023
• First Submitted That Met QC Criteria: July 28, 2023
• First Posted (Actual): August 7, 2023

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: A999999

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No