Food Pharmacy at Oregon Health & Science University (OHSU) Knight Cardiovascular Institute (KCVI)

Oregon Health & Science University (OHSU)

Status: Completed

Conditions: Hyperlipidemias

Treatments: Dietary Supplement: Fruit and vegetable deliveries

Study type: Interventional

Funder types: Other

Identifiers

NCT04036773

19413

Details and patient eligibility

About

Participants in the intervention group of this study will receive weekly home deliveries of fruit & vegetables for 3 months. The primary objective of this study is to determine if increased access to fruits and vegetables leads to sustained dietary changes, measured through changes in the Healthy Eating Index (HEI). Secondary objectives are to determine whether increased fruit and vegetable access (increased HEI) ultimately leads to improved cardiovascular (CV) health indicators (e.g., body mass index, waist circumference, blood pressure, and levels of blood lipids and hemoglobin A1c).

Enrollment: 20 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 19 years and older
• Established patient at OHSU Center for Preventive Cardiology
• Not requiring changes to medication regimen for the 6-month study duration
• Must be eligible to register with produce delivery company (reside in Portland-metro area; have access to a computer with internet service; able to read English)

Exclusion criteria

• Triglycerides > 500 mg/dL
• Heavy alcohol use (> 3 drinks/day)
• Uncontrolled hypertension (BP > 140/90)
• LDL-C > 160 mg/dL
• Uncontrolled diabetes mellitus (HbA1c > 8%)
• Failure to provide informed consent
• Current pregnancy
• Healthy Eating Index (HEI) score of ≥ 80

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

20 participants in 2 patient groups

Intervention Group

Experimental group

Treatment:

Dietary Supplement: Fruit and vegetable deliveries

Control Group

No Intervention group