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
- Dyslipidemia
- Hypertension
- Obesity & Overweight
Eligibility Criteria
- Sex
- ALL
- Age
- 2 Years - 17 Years
- Healthy Volunteers
- Not accepted
Interventions
- Nutrition education and produce prescription card — BEHAVIORALParticipants 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
- Shannon M Lyon, DO, MSc617-355-0955
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | - |
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