Comparison of Produce Prescription Benefit Dosage

NCT05978843 | Completed

• 1 other identifier: A999999
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Food Insecurity

Outcome Measures

Primary Outcomes (1)

• Benefit redemption

  Dollar amount of benefits redeemed (numerator) over total dollar amount of benefits distributed (denominator)

  Monthly for 6 months

Secondary Outcomes (2)

• Fruit and vegetable consumption

  0, 3, and 6 months

• Food security status

  0, 3, and 6 months

Study Arms (3)

Arm 1 - 10% TFP

ACTIVE COMPARATOR

Participants will receive $40/month in fruit and vegetable benefits for 6 months ($240 total).

Behavioral: Monetary benefit to purchase fruits and vegetables

Arm 2 - 20% TFP

ACTIVE COMPARATOR

Participants will receive $80/month in fruit and vegetable benefits for 6 months ($480 total).

Behavioral: Monetary benefit to purchase fruits and vegetables

Arm 3 - 30% TFP

ACTIVE COMPARATOR

Participants will receive $110/month in fruit and vegetable benefits for 6 months ($660).

Behavioral: Monetary benefit to purchase fruits and vegetables

Interventions

Monetary benefit to purchase fruits and vegetables BEHAVIORAL

Participants will receive varying benefit amounts to purchase fruits and vegetables.

Arm 1 - 10% TFP; Arm 2 - 20% TFP; Arm 3 - 30% TFP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• Not enrolled in a First Five Program at El Concilio California
• Actively receiving another V4V/EatSF card

Sponsors & Collaborators

• University of California, San Francisco: lead
• American Heart Association: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94110, United States

Location

Related 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.

  PMID: 23757436 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 20032485 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 35684128 BACKGROUND

• 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.

  PMID: 36161127 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Interventions

Vegetables

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Hilary Seligman, MD, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized into one of three arms. Each arm will receive a different benefit amount during the 6-month intervention period, with benefit amounts determined by a percentage of the Thrifty Food Plan (TFP) - the USDA food plan used to calculate SNAP benefit rates. For ethical reasons, participants will each receive the same total benefit amount over the course of the study, with those randomized to the lower benefit arms receiving the difference between the value of the benefits issued to them and the value of the benefits issued to the highest dose group as a lump sum payment at the end of the study.

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: August 7, 2023
• Study Start: March 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)