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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Children's Hospital
Study ID
NCT07545005
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 17 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
Apr 2026
Primary completion
Sep 1, 2028
Completion
Apr 1, 2029

Study Design

Enrollment
150 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Nutrition intervention arm

Primary Outcome Measure

Fruit and vegetable consumption [ Time Frame: Change from baseline at 6 months and 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115-

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