Produce Prescription + Nutrition Education for Cardiovascular Health in Youth

SM
Overseen ByShannon M Lyon, DO, MSc
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Boston Children's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 2 and 17 years old and have a caregiver.
2. Patient at BCH
I have high blood pressure.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Intervention

The first 15 dyads participate in the pilot intervention, attending 3-4 nutrition classes and completing a qualitative interview

2 months
3-4 virtual classes

Main Intervention

Participants receive $50 monthly deposits on a produce prescription debit card and attend biweekly nutrition classes

6 months
Biweekly virtual classes

Follow-up

Participants are monitored for changes in fruit and vegetable consumption, blood pressure, cholesterol, BMI, and food security

6 months
Assessments at 6 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Nutrition education and produce prescription card

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Nutrition intervention armExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials
801
Recruited
5,584,000+

USDA Food and Nutrition Service

Collaborator

Trials
10
Recruited
173,000+