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

NCT ID: NCT07117201

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-03
• Study Completion Date: 2026-08-31

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?

Detailed Description

Expanding the PPP over 12 months, incorporating additional healthy food items to increase variety, and including cooking skill sessions within the PPP will enhance participants' confidence in preventing and managing their chronic diseases. This initial assessment of the program will provide essential data for expansion and implementation. This PPP intervention will promote health equity by expanding the reach of our program and helping participants overcome SDOH, such as food insecurity, that prevent optimal diet quality and management of chronic diseases. Furthermore, continuous or more frequent monitoring of SDOH, provision of a variety of healthy food items, and lifestyle behavior change education should increase participant adherence to a more nutritious diet and medication management required for chronic disease management, and improve participants' chronic disease self-efficacy.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Prescription Produce Program (PPP)

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

Group Type: ACTIVE_COMPARATOR

Prescription Produce Plan

Intervention Type: 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) + Cooking Classes

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.

Group Type: EXPERIMENTAL

Culturally Tailored Cooking Classes

Intervention Type: 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.

Prescription Produce Plan

Intervention Type: 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.

Interventions

Culturally Tailored Cooking Classes

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.

Intervention Type: BEHAVIORAL

Prescription Produce Plan

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Ana Diallo

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ana Diallo

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University Mobile Health and Wellness Program

Richmond, Virginia, United States

Countries

United States

Other Identifiers

VCU HM20032577

Identifier Type: -

Identifier Source: org_study_id