Clinical trial

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

Opening soon · Not applicable · 1 countries · Registry ID NCT07545005

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age2 Years to 17 Years

SexAll

Healthy volunteersNot accepted

ConditionDyslipidemia, Hypertension, Obesity & Overweight

Full registry criteria

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

Treatments and study arms

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.

Primary outcomes

Fruit and vegetable consumptionChange from baseline at 6 months and 12 months

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Boston Children's Hospital🇺🇸 Boston, Massachusetts, United States

Open map