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

NCT07545005 | Not Yet Recruiting

• 2 other identifiers: IRB-P000523762025-70413-45169
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dyslipidemia; Hypertension; Obesity & Overweight

Keywords

Food insecurity; food is medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in blood pressure

  Absolute and percent change in blood pressures will be measured between baseline, 6 months, and 12 months.

• Non-HDL cholesterol

  Absolute and percent change will be reported from baseline to 6 months and 12 months.

• Body Mass Index (BMI)

  Change in BMI percentile will be reported from baseline to 6 months and 12 months.

• Food security

  Food security group will be measured at baseline, 6 months, and 12 months

Study Arms (1)

Nutrition intervention arm

EXPERIMENTAL

Behavioral: Nutrition education and produce prescription card

Interventions

Nutrition education and produce prescription card BEHAVIORAL

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.

Nutrition intervention arm

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Ages 2-17 years (with caregiver)
• Patient at BCH AND
• Underlying cardiovascular risk condition:
• High Blood Pressure
• Dyslipidemia
• Elevated BMI AND
• Enrolled in or eligible for a Medicaid Healthcare plan OR
• SNAP eligible

You may not qualify if:

• \. Conditions that require urgent treatment:
• Hypertensive Urgency
• Hypertensive Emergency
• Dialysis-dependent kidney disease

Sponsors & Collaborators

• Boston Children's Hospital: lead
• USDA Food and Nutrition Service: collaborator

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Dyslipidemias; Hypertension; Obesity; Overweight

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Central Study Contacts

Shannon M Lyon, DO, MSc

CONTACT

617-355-0955; shannon.lyon@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 22, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

US (1)