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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-17
SponsorBoston Children's Hospital

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Nutrition intervention armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Change from baseline at 6 months and 12 months

Secondary outcomes

1

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.

Time frame
Absolute and percent change in blood pressures will be measured between baseline, 6 months, and 12 months.
2

Non-HDL cholesterol

Non-HDL cholesterol will be obtained from a fasting lipid-panel, obtained in the clinical setting.

Time frame
Absolute and percent change will be reported from baseline to 6 months and 12 months.
3

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.

Time frame
Change in BMI percentile will be reported from baseline to 6 months and 12 months.
4

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.

Time frame
Food security group will be measured at baseline, 6 months, and 12 months

Other outcomes

Sponsors and contacts

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Boston Children's Hospital

Lead sponsor

USDA Food and Nutrition Service

Collaborator

This trial is not recruiting at the moment. You can still explore other options: