About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ages 2-17 years (with caregiver)
Patient at BCH AND
High Blood Pressure
Dyslipidemia
Disqualifiers
Hypertensive Urgency
Hypertensive Emergency
Dialysis-dependent kidney disease
Trial design
Single group
Treatments tested in this trial
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.
Treatment groups
Trial outcomes
Primary outcomes
Fruit and vegetable consumption
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.
Secondary outcomes
Change in blood pressure
Blood pressure will be measured in the clinical setting. When more than one blood pressure is measured, the average blood pressure during the clinical encounter will be recorded. Systolic and diastolic blood pressure will be recorded.
Non-HDL cholesterol
Non-HDL cholesterol will be obtained from a fasting lipid-panel, obtained in the clinical setting.
Body Mass Index (BMI)
BMI will be measured using the Haycock formula from height and weight obtained in the clinical setting. Because this is a pediatric population, BMI percentile will be reported.
Food security
Food security will be measured with the Six-Item Short Form of the USDA Food Security Survey module. The 6-item or 'short form' scale provides a reliable substitute for the full USDA 18- item household food security survey, with less respondent burden. The 6-item scale can assign respondents' food security status to high or marginal food security, low food security, and very low food security based on a score ranked 0-6. Food security groups will be reported.
Sponsors and contacts
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Boston Children's Hospital
Lead sponsor
USDA Food and Nutrition Service
Collaborator
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