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Comparison of Produce Prescription Benefit Dosage

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ClinicalTrials.gov Identifier: NCT05978843
Recruitment Status : Enrolling by invitation
First Posted : August 7, 2023
Last Update Posted : May 16, 2024
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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.
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Comparison of Produce Prescription Benefit Dosage on Redemption
Actual Study Start Date : March 1, 2024
Estimated Primary Completion Date : November 28, 2024
Estimated Study Completion Date : November 28, 2024
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Benefit redemption [ Time Frame: Monthly for 6 months ]
    Dollar amount of benefits redeemed (numerator) over total dollar amount of benefits distributed (denominator)


Secondary Outcome Measures :
  1. Fruit and vegetable consumption [ Time Frame: 0, 3, and 6 months ]
    Measured by NCI Dietary Screener Questionnaire (DSQ) and reported in cup-equivalents, a higher score indicates greater fruit and vegetable intake (better outcome)

  2. Food security status [ Time Frame: 0, 3, and 6 months ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

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
  • Not enrolled in a First Five Program at El Concilio California
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05978843


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
American Heart Association
Investigators
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Principal Investigator: Hilary Seligman, MD, MAS University of California, San Francisco
More Information
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Publications:

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05978843    
Other Study ID Numbers: A999999
First Posted: August 7, 2023    Key Record Dates
Last Update Posted: May 16, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No