Promoting Nutrition Security and Chronic Disease Management Through a Produce Prescription Program

NCT07117201 | Enrolling By Invitation

• 1 other identifier: VCU HM20032577
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to assess the feasibility to implement a prescription produce program (PPP) over 12-months within a community-based health and wellness program. The main questions it aims to answer are: a) does participation in the PPP improve participants' nutrition and food security status, health outcomes, diet quality and chronic disease management between baseline and 12 months after participating in the PPP? b) what is the cost-benefit analysis of the PPP implementation?

Conditions

Dietary Intervention; Produce Prescription; Chronic Disease Management; Social Needs Screening

Outcome Measures

Primary Outcomes (3)

• Change from baseline in food security status at 12 months

  The Hunger Vital Sign is a validated, two-question screening tool used to identify households at risk of food insecurity. It asks if within the past 12 months, the household has "worried whether our food would run out before we got money to buy more" or if "the food we bought just didn\\'t last, and we didn\\'t have money to get more". Answering that either statement is "often true" or "sometimes true" indicates a household is at risk.

  From baseline to the end of intervention at 12 months

• Change in social needs

  The Social Needs Screening short survey will be used to measure social drivers of health, including housing, food insecurity, transportation, delayed care, and financial strain. Each domain is evaluated separately. A positive response is determined for each specific category (e.g., housing, food) rather than through a cumulative score.

  During active intervention from baseline to the end of study participation at 12 months

• Change from baseline in nutrition security status at 12 months

  1-item Brief Nutrition Security Screener, Question: In the last 12 months, (I/we) worried that the food (I was/we were) able to eat would hurt (my/our) health and well-being. Response options: Always true Often true Sometimes true Never true Don't know / Refused Interpretation Responses of "Always true," "Often true," or "Sometimes true" typically indicate a level of nutrition insecurity.

  From baseline to the end of intervention at 12 months

Secondary Outcomes (10)

• Change in hemoglobin A1c from baseline to 12 months

  From baseline to end of study participation at 12 months

• Change in diet quality from baseline to 12 months

  From baseline to end of study participation at 12 months

• Wellness goals set and completed during active study.

  During active study engagement from baseline to end of study participation at 12 months

• Change in global health from baseline to 12 months

  From baseline to end of study participation at 12 months

• Change in food medication trade-offs from baseline to 12 months

  From baseline to end of study participation at 12 months

Study Arms (2)

Standard Prescription Produce Program (PPP)

ACTIVE COMPARATOR

The preliminary clinical effectiveness of the program on nutrition and food security status, diet quality as well as chronic disease management of individuals participating in the study

Behavioral: Prescription Produce Plan

Standard Prescription Produce Program (PPP) + Cooking Classes

EXPERIMENTAL

The preliminary clinical effectiveness of the program on nutrition and food security status, diet quality as well as chronic disease management of individuals participating in the study AND cooking classes offered by Delicious Legacy.

Behavioral: Culturally Tailored Cooking Classes; Behavioral: Prescription Produce Plan

Interventions

Culturally Tailored Cooking Classes BEHAVIORAL

Cooking skills session will be offered by the Delicious Legacy Program. The Delicious Legacy program is a culturally tailored, community-based nutrition and wellness intervention designed to promote health equity. Rooted in the intergenerational transmission of knowledge, the program emphasizes family socialization practices related to food, health beliefs, and caregiving. It integrates evidence-based nutritional education with ancestral foodways to address diet-related chronic illnesses while fostering cultural pride and resilience. Through interactive workshops, individuals engage in hands-on learning that reinforces traditional roles in food preparation and shared meals as sites of emotional support and identity formation.

Standard Prescription Produce Program (PPP) + Cooking Classes

Prescription Produce Plan BEHAVIORAL

The standard PPP includes three major parts. 1) Screening and personalized referrals/support for social needs including food, housing, health insurance and transportation by a community health worker. 2) Bi-weekly wellness visits with an MHWP team of interprofessional healthcare students, supervised by a clinical faculty, and guided by the participants' health and social needs and interests. They include education and SMART-EST goals around nutrition, physical activities, chronic disease management, care coordination, and/or recipes. 3) Delivery of a bag of fresh fruits and vegetables as well as heart healthy food items every two weeks over a period of 12 months. The produce bags will be made by the Underground Kitchen, a local non-profit organization creating curated bags of healthy food items and recipes to support the prevention and management of chronic diseases.

Standard Prescription Produce Program (PPP); Standard Prescription Produce Program (PPP) + Cooking Classes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a participant in the Mobile Health and Wellness Program;
• an English-speaking adult aged 18 or over
• diagnosed with hypertension, high cholesterol, diabetes type 2 or pre-diabetes, arthritis, obesity, CHF, and/or COPD
• taking medication for at least one of the eligible chronic conditions listed previously.

You may not qualify if:

• a prior diagnosis of dementia-related conditions: Alzheimer's disease, Lewy body, Parkinson's, or vascular dementia
• unwilling or unable to attend at least half of the 24 team visits during the study period.

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University Mobile Health and Wellness Program

Richmond, Virginia, 23298, United States

Location

Study Officials

• Ana Diallo

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: August 12, 2025
• Study Start: September 3, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)