Comparison of Produce Prescription Benefit Dosage

Food Insecurity Clinical Trial

Official title:

Comparison of Produce Prescription Benefit Dosage on Redemption

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05978843
• Other study ID #: A999999
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2023
• Est. completion date: December 2024

Study information

• Verified date: August 2023
• Source: University of California, San Francisco
• Contact: Hilary Seligman, MD, MAS
• Phone: (628) 206-4448
• Email: hilary.seligman[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Food Insecurity

Intervention

Behavioral:
• Monetary benefit to purchase fruits and vegetables
Participants will receive varying benefit amounts to purchase fruits and vegetables.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	American Heart Association

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Benefit redemption	Dollar amount of benefits redeemed (numerator) over total dollar amount of benefits distributed (denominator)	Monthly for 6 months
Secondary	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
Secondary	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