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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
2 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 months, 3 months
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Post-intervention surveys and assessments will be completed at 6 months and 12 months."
  • "Change in FV consumption will be measured by obtaining a baseline, 6 month, and 12 month 10-item Dietary Screener Questionnaire (DSQ)."
  • "Themes identified from the pilot qualitative survey 3."
  • "Food security will be measured with the Six-Item Short Form of the USDA Food Security Survey module."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether help buying fruits and vegetables, along with online nutrition classes, can improve heart and blood vessel health over time. It is for children ages 2–17 at Boston Children's Hospital who have heart health risk factors and qualify for Medicaid or SNAP food benefits.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 2–17, with a caregiver.
  • A patient at Boston Children's Hospital.
  • Have high blood pressure, abnormal cholesterol, or a high body mass index (BMI, a measure of weight compared with height).
  • Be enrolled in or eligible for Medicaid health coverage, or be eligible for SNAP food benefits.

Who can't join

  • Very high blood pressure that needs urgent or emergency treatment.
  • Kidney disease that requires dialysis, a treatment that filters the blood.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

MA