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Предстои набиране Не е приложимо NCT07545005

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

Не е приложима фаза (напр. обсервационно)
Заболявания: Dyslipidemia Hypertension Obesity & Overweight

Спонсор: Boston Children's Hospital

Налично на: БГ
Обобщение
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.
Описание
This is a single-center, prospective interventional study to evaluate the effect of a providing pre-paid produce prescription debit cards and participating in nutrition classes on fruit and vegetable (FV) intake, cardiovascular health, and food security in a cohort of participants with risk factors for cardiovascular disease. We will recruit 150 dyads (participants and parents) between the ages of 2-17 years old along with their caregiver from the Boston Children's Hospital (BCH) pediatric cardiology outpatient clinics. Patients will qualify for enrollment if they have cardiovascular risk factors including high blood pressure, elevated non-HDL cholesterol, or elevated BMI and who qualify for (1) Benefits under the Food and Nutrition Act of 2008 (7 USC 2011 et seq.); or enrolled in (2) medical assistance under a State plan or a waiver of such a plan under title XIX of the Social Security Act (42 USC 1392 et seq.). We will exclude patients who have hypertensive urgency or emergency or end-stage renal disease. Participants enrolled in this study will receive $50 monthly deposits loaded onto a Fresh Connect produce prescription debit card for six months, and will attend biweekly nutrition classes for three months. Participants will complete a baseline survey assessing diet quality and food security. Patient contact information will be provided to the Fresh Connect team, who will facilitate card enrollment and provide ongoing support. The nutrition classes will be led by a dietitian who specializes in pediatric preventive cardiology and will be offered in English and Spanish. These classes will be conducted via a virtual Zoom platform. Course content will begin with an introduction to DASH and Mediterranean-style eating patterns, which align with healthy cardiovascular eating patterns with additional sessions discussing different aspects of healthy eating, including nutrition label reading and cooking classes. As classes progress, we will focus on nutrition education and incorporate cooking skills by preparing a recipe during the class. To encourage participation, we will send the recipe and ingredients needed ahead of time so that families can join in from home as they watch the virtual class. We will focus on simple, inexpensive recipes that feed an entire family. We will allow time for feedback and ideas for different fruits or vegetables that participants would like to try as the classes progress. Given the diversity of participants to be enrolled, we will plan to make the sessions culturally relevant and appropriate by involving families from the communities we serve in the creation of the curriculum. We plan to host groups of 10-20 dyads in each class to allow for interaction between participants and between participants and our dietitian. Post-intervention surveys and assessments will be completed at 6 months and 12 months. Pilot intervention: The first 15 dyads enrolled into this study will be considered the pilot group. At the end of thei
Кой може да участва
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
Интервенции
Nutrition education and produce prescription card
BEHAVIORAL
Места на провеждане 1
САЩ (1)
Boston Children's Hospital
Boston , Massachusetts
Технически детайли
Статус
Предстои набиране
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
2 Years
Максимална възраст
17 Years
Здрави доброволци
Не
Начална дата
01.06.2026
Крайна дата
01.04.2029
Регистрационен номер
NCT07545005
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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