Comparison of Produce Prescription Benefit Dosage

Sponsor

University of California, San Francisco (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05978843

Collaborator

American Heart Association (Other)

240

Enrollment

Location

Arms

Anticipated Duration (Months)

17.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Food Insecurity	Behavioral: Monetary benefit to purchase fruits and vegetables	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

Comparison of Produce Prescription Benefit Dosage on Redemption

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Benefit redemption [Monthly for 6 months]
Dollar amount of benefits redeemed (numerator) over total dollar amount of benefits distributed (denominator)

Secondary Outcome Measures

Fruit and vegetable consumption [0, 3, and 6 months]
Measured by NCI Dietary Screener Questionnaire (DSQ)
Food security status [0, 3, and 6 months]
Measured by USDA 6-item food security module

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Francisco	San Francisco	California	United States	94110

Sponsors and Collaborators

University of California, San Francisco
American Heart Association

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Hilary Seligman, MD, Professor of Medicine, University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT05978843

Other Study ID Numbers:

A999999

First Posted:

Aug 7, 2023

Last Update Posted:

Aug 7, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 7, 2023