Dietary InterventionNCT07117201
Promoting Nutrition Security and Chronic Disease Management Through a Produce Prescription Program
A study testing Culturally Tailored Cooking Classes and Prescription Produce Plan in people with Dietary Intervention and Produce Prescription, run by Virginia Commonwealth University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dietary Intervention, Produce Prescription, Chronic Disease Management
- What is being tested?
- Culturally Tailored Cooking Classes and Prescription Produce Plan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Virginia Commonwealth University Mobile Health and Wellness Program
Richmond, Virginia, 23298
About this study
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?
Read the 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
- Being tested
- Culturally Tailored Cooking Classes, Prescription Produce Plan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally Tailored Cooking ClassesBehavioural
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 PlanBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Culturally Tailored Cooking Classes; Behavioral: Prescription Produce Plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From baseline to the end of intervention at 12 months
Secondary outcomes (10)
Change in hemoglobin A1c from baseline to 12 months
Blood glucose level measured by hemoglobin A1c (HbA1c) levels using the DCA Vantage® Analyzer for individuals with diabetes and pre-diabetes
Measured: From baseline to end of study participation at 12 months
Change in diet quality from baseline to 12 months
Dietary quality measured as the Healthy Eating Index using the DietID™, an assessment tool capturing dietary intake through an innovative Diet Quality Photo Navigation (DQPN®) software. Users are shown a series of food images representing different eating patterns and select the one that most closely resembles their own.The selected pattern is then evaluated using the HEI 2020 scoring system, a well-validated measure of how closely a diet aligns with the Dietary Guidelines for Americans. The HEI score (0-100) is converted into a simpler 1-10 scale, with 10 being the highest quality diet and 1 being the lowest.
Measured: From baseline to end of study participation at 12 months
Wellness goals set and completed during active study.
Participants set a study-specific wellness goal related to lifestyle behaviors and chronic disease management at study baseline. Wellness goals are categorized by type of activity (e.g., physical activity, vegetable intake). During the MHWP team visits, participants will be supported to identify and design health and lifestyle behavior goals which will be SMART- EST (Specific, Measurable, Achievable, Relevant, Time-bound, Evidence-based, Strategic and Tailored). Participants provide progress updates and work towards optional action steps during visits through qualitative responses. Participants report if they achieved their wellness goal at study endpoint.
Measured: During active study engagement from baseline to end of study participation at 12 months
Change in global health from baseline to 12 months
PROMIS Global Health includes global perceptions of general health that cut across physical and mental domains. The measure will assess the potential impact of the PPP on participants' overall health and chronic disease management. PROMIS Global Health scoring involves using the scores from specific health questions to calculate two summary scores: a Global Physical Health Score and a Global Mental Health Score. These scores are then standardized into "T-scores," where a score of 50 represents the average for the general population, with a standard deviation of 10
Measured: From baseline to end of study participation at 12 months
Change in food medication trade-offs from baseline to 12 months
Food/medication trade-offs which will assess trade-offs between food and medications or diabetes supplies if they reported having a diagnosis of type 2 diabetes. We will use the following four Likert-scale questionnaire with response on 'often', 'sometimes', 'rarely' or 'never' to answer: "How often have you…:(1) put off buying food so that you would have money to buy medicines? (2) put off buying medicines so that you would have money to buy food? (3) put off buying diabetes supplies, like test strips or lancets, so that you would have money to buy food? (4) put off buying food so that you would have money to buy diabetes supplies, like test strips or lancets
Measured: From baseline to end of study participation at 12 months
Change in healthcare utilization
Self-reported healthcare utilization during team visits to include: last time seen at PCP, any hospitalizations or ER visits since last PPP visit or within the last month, # hospital and ER visits in last month, reasons for hospital and ER visits assessed during team visits. No standardized tool will be used.
Measured: During active study participation from baseline to 12 months
Change in weight from baseline to 12 months
Body weight measured using a calibrated digital scale
Measured: From baseline to end of study participation at 12 months
Change in adiposity from baseline to 12 months
Adiposity which will be measured by waist circumference using the National Health and Nutrition Examination Survey protocol
Measured: From baseline to end of study participation at 12 months
Change in blood pressure from baseline to 12 months
Blood pressure (SBP/DBP) measured by the Omron Hem 705 CP Auto Inflate BP Monitor
Measured: From baseline to end of study participation at 12 months
Change in medication adherence from baseline to 12 months
Medication adherence will be measured using the Adherence to Refills and Medications Scale (ARMS) which assesses adherence with the filling or refilling of prescriptions, and adherence with taking medications. The Adherence to Refills and Medications Scale (ARMS) scoring involves summing the responses from its 12 items, each rated on a four-point scale (1 = none of the time, 4 = all of the time). Scores are then totaled to produce an overall score ranging from 12 to 48. A crucial part of the original scoring is a reverse coding of one item (usually item 12), meaning a higher score indicates poorer adherence, while a lower score indicates better adherence.
Measured: From baseline to end of study participation at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start3 Sep 2025
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary InterventionStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Diallo, Virginia Commonwealth University
- Investigators
- Ana Diallo, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117201
- Sponsor's protocol ID
- VCU HM20032577
- Status last verified
- Dec 2025
- First submitted
- 30 Jun 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Nutrition Security and Chronic Disease Management Through a Produce Prescription Program
- ClinicalTrials.gov ID
- NCT07117201
- Acronym / sponsor ID
- VCU HM20032577
- Conditions
- Dietary Intervention, Produce Prescription, Chronic Disease Management, Social Needs Screening
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Prescription Produce Program (PPP) | Active comparator | Behavioral: Prescription Produce PlanThe 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 |
| Standard Prescription Produce Program (PPP) + Cooking Classes | Experimental | Behavioral: Culturally Tailored Cooking Classes, Behavioral: Prescription Produce PlanThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culturally Tailored Cooking ClassesCooking 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. | Behavioural | Standard Prescription Produce Program (PPP) + Cooking Classes |
| Prescription Produce PlanThe 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. | Behavioural | Standard Prescription Produce Program (PPP), Standard Prescription Produce Program (PPP) + Cooking Classes |
Primary outcome
Change from baseline in food security status at 12 months
Time frame: From baseline to the end of intervention 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.
Change in social needs
Time frame: During active intervention from baseline to the end of study participation at 12 months
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.
Change from baseline in nutrition security status at 12 months
Time frame: From baseline to the end of intervention 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.
10 secondary outcomes
Change in hemoglobin A1c from baseline to 12 months
Time frame: From baseline to end of study participation at 12 months
Change in diet quality from baseline to 12 months
Time frame: From baseline to end of study participation at 12 months
Wellness goals set and completed during active study.
Time frame: During active study engagement from baseline to end of study participation at 12 months
Change in global health from baseline to 12 months
Time frame: From baseline to end of study participation at 12 months
Change in food medication trade-offs from baseline to 12 months
Time frame: From baseline to end of study participation at 12 months
Change in healthcare utilization
Time frame: During active study participation from baseline to 12 months
Change in weight from baseline to 12 months
Time frame: From baseline to end of study participation at 12 months
Change in adiposity from baseline to 12 months
Time frame: From baseline to end of study participation at 12 months
Change in blood pressure from baseline to 12 months
Time frame: From baseline to end of study participation at 12 months
Change in medication adherence from baseline to 12 months
Time frame: From baseline to end of study participation at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ana Diallo principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally Tailored Cooking Classes and Prescription Produce Plan in people with Dietary Intervention and Produce Prescription, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in food security status at 12 months (time frame: From baseline to the end of intervention at 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.