Impact of a Produce Prescription Program and Nutrition Education Intervention on Cardiovascular Health in Youth

This study will assess the effect of a produce prescription program combined with nutritional classes on short and longer-term cardiovascular health in a cohort of children at risk for cardiovascular disease. The communities of interest we aim to engage in this project are children and adolescents in Boston and the surrounding areas with acquired cardiovascular risk factors of high blood pressure or abnormal cholesterol that are cared for at Boston Children's Hospital and who qualify or are enrolled in (1) Benefits under the Food and Nutrition Act of 2008; (2) medical assistance under a State plan or a waiver of such a plan under title XIX of the Social Security. This project will create a first-time partnership between the BCH cardiology department and a produce prescription program (Fresh Connect) and will introduce services and resources not previously available to these patients. Participants will be able to use the Fresh Connect pre-paid debit card to purchase fruits and vegetables of their choosing from numerous local food retailers convenient to their own neighborhood. We currently do not have any healthcare-led social support networks amongst patients seen for evaluation of cardiovascular risk factors. As such, this project will introduce a new community-building resource amongst our patients by creating interactive, culturally tailored nutritional classes. The virtual nutrition classes will offer a friendly, interactive environment in which patients and families can share their experiences and learn from each other and from our dietitians. By fostering these relationships amongst patients/caregivers, we hope to decrease the stigma some families feel when their child is diagnosed with hypertension or abnormal cholesterol.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension; Dyslipidemia; Obesity & Overweight
• Intervention / Treatment: Behavioral: Nutrition education and produce prescription card

Detailed Description

This is a single-center, prospective interventional study to evaluate the effect of a providing pre-paid produce prescription debit cards and participating in nutrition classes on fruit and vegetable (FV) intake, cardiovascular health, and food security in a cohort of participants with risk factors for cardiovascular disease.

We will recruit 150 dyads (participants and parents) between the ages of 2-17 years old along with their caregiver from the Boston Children's Hospital (BCH) pediatric cardiology outpatient clinics. Patients will qualify for enrollment if they have cardiovascular risk factors including high blood pressure, elevated non-HDL cholesterol, or elevated BMI and who qualify for (1) Benefits under the Food and Nutrition Act of 2008 (7 USC 2011 et seq.); or enrolled in (2) medical assistance under a State plan or a waiver of such a plan under title XIX of the Social Security Act (42 USC 1392 et seq.). We will exclude patients who have hypertensive urgency or emergency or end-stage renal disease.

Participants enrolled in this study will receive $50 monthly deposits loaded onto a Fresh Connect produce prescription debit card for six months, and will attend biweekly nutrition classes for three months. Participants will complete a baseline survey assessing diet quality and food security.

Patient contact information will be provided to the Fresh Connect team, who will facilitate card enrollment and provide ongoing support. The nutrition classes will be led by a dietitian who specializes in pediatric preventive cardiology and will be offered in English and Spanish. These classes will be conducted via a virtual Zoom platform. Course content will begin with an introduction to DASH and Mediterranean-style eating patterns, which align with healthy cardiovascular eating patterns with additional sessions discussing different aspects of healthy eating, including nutrition label reading and cooking classes. As classes progress, we will focus on nutrition education and incorporate cooking skills by preparing a recipe during the class. To encourage participation, we will send the recipe and ingredients needed ahead of time so that families can join in from home as they watch the virtual class. We will focus on simple, inexpensive recipes that feed an entire family. We will allow time for feedback and ideas for different fruits or vegetables that participants would like to try as the classes progress. Given the diversity of participants to be enrolled, we will plan to make the sessions culturally relevant and appropriate by involving families from the communities we serve in the creation of the curriculum. We plan to host groups of 10-20 dyads in each class to allow for interaction between participants and between participants and our dietitian. Post-intervention surveys and assessments will be completed at 6 months and 12 months.

Pilot intervention: The first 15 dyads enrolled into this study will be considered the pilot group. At the end of their second month of participation, after they have completed 3-4 nutrition classes, they will be asked to complete a qualitative interview assessing satisfaction with the classes and inquiring about suggestions for improvement. After this data is analyzed, we will enroll a larger prospective cohort of 135 dyads over the next 34 months. During this time, the pilot group will complete the remainder of the study.

Primary outcome:

1. Our primary outcome will be change in FV consumption from baseline to 6 months for the entire study population. Change in FV consumption will be measured by obtaining a baseline, 6 month, and 12 month 10-item Dietary Screener Questionnaire (DSQ). This short 10-item dietary assessment tool is from the larger 26-item Dietary Screener Questionnaire (DSQ) developed by the National Institutes of Health (NIH) National Cancer Institute (NCI), and was chosen because: (1) it is validated, (2) it is tested in similar, low-income populations, (3) it can be self-administered, (4) it does not require participants to report serving size, which can be challenging even for people with high numeracy skills, (5) it is relatively precise and accurate, unlike shorter instruments, and (6) it is sensitive enough to change with relatively small changes in dietary intake. The 10-item DSQ scale collects consumption frequency of fruits, fruit juices, and vegetables in the past 30 days. Scoring algorithms convert frequency responses to cup equivalent estimates of average daily dietary intake for fruits and vegetables, using an age and gender coefficient.

   Secondary outcomes:

2. Themes identified from the pilot qualitative survey
3. Blood pressure will be measured in the clinical setting. When more than one blood pressure is measured, the average blood pressure during the clinical encounter will be recorded. Systolic and diastolic blood pressure will be recorded. Absolute and percent change in blood pressures will be measured between baseline, 6 months, and 12 months.
4. Non-HDL cholesterol will be obtained from a fasting lipid-panel, obtained in the clinical setting. Absolute and percent change will be reported from baseline to 6 months and 12 months.
5. BMI will be measured using the Haycock formula from height and weight obtained in the clinical setting. Because this is a pediatric population, BMI percentile will be reported. Change in BMI percentile will be reported from baseline to 6 months and 12 months.
6. Food security will be measured with the Six-Item Short Form of the USDA Food Security Survey module. The 6-item or 'short form' scale provides a reliable substitute for the full USDA 18- item household food security survey, with less respondent burden. The 6-item scale can assign respondents' food security status to high or marginal food security, low food security, and very low food security based on a score ranked 0-6. Food security groups will be reported.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shannon M Lyon, DO, MSc; Phone Number: 617-355-0955; Email: shannon.lyon@childrens.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Ages 2-17 years (with caregiver)
2. Patient at BCH AND

3. Underlying cardiovascular risk condition:

   1. High Blood Pressure
   2. Dyslipidemia
   3. Elevated BMI AND
4. Enrolled in or eligible for a Medicaid Healthcare plan OR
5. SNAP eligible

Exclusion Criteria:

1. Conditions that require urgent treatment:

1. Hypertensive Urgency
2. Hypertensive Emergency
3. Dialysis-dependent kidney disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutrition intervention arm	Behavioral: Nutrition education and produce prescription card; Participants will participate in 6 virtual nutrition classes and will receive monthly deposits to a debit card, which may be used to purchase fruits and vegetables at local grocery stores.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fruit and vegetable consumption	Our primary outcome will be change in FV consumption from baseline to 6 months for the entire study population. Change in FV consumption will be measured by obtaining a baseline, 6 month, and 12 month 10-item Dietary Screener Questionnaire (DSQ). This short 10-item dietary assessment tool is from the larger 26-item Dietary Screener Questionnaire (DSQ) developed by the National Institutes of Health (NIH) National Cancer Institute (NCI). The 10-item DSQ scale collects consumption frequency of fruits, fruit juices, and vegetables in the past 30 days. Scoring algorithms convert frequency responses to cup equivalent estimates of average daily dietary intake for fruits and vegetables, using an age and gender coefficient.	Change from baseline at 6 months and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood pressure	Blood pressure will be measured in the clinical setting. When more than one blood pressure is measured, the average blood pressure during the clinical encounter will be recorded. Systolic and diastolic blood pressure will be recorded.	Absolute and percent change in blood pressures will be measured between baseline, 6 months, and 12 months.
Non-HDL cholesterol	Non-HDL cholesterol will be obtained from a fasting lipid-panel, obtained in the clinical setting.	Absolute and percent change will be reported from baseline to 6 months and 12 months.
Body Mass Index (BMI)	BMI will be measured using the Haycock formula from height and weight obtained in the clinical setting. Because this is a pediatric population, BMI percentile will be reported.	Change in BMI percentile will be reported from baseline to 6 months and 12 months.
Food security	Food security will be measured with the Six-Item Short Form of the USDA Food Security Survey module. The 6-item or 'short form' scale provides a reliable substitute for the full USDA 18- item household food security survey, with less respondent burden. The 6-item scale can assign respondents' food security status to high or marginal food security, low food security, and very low food security based on a score ranked 0-6. Food security groups will be reported.	Food security group will be measured at baseline, 6 months, and 12 months

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: USDA Food and Nutrition Service

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: April 16, 2026
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Food insecurity; food is medicine
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Lipid Metabolism Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Hypertension; Dyslipidemias; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Epidemiologic Measurements; Nutrition Assessment
• Other Study ID Numbers: IRB-P00052376; 2025-70413-45169 (Other Grant/Funding Number: USDA Gusnip)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No