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

Overview

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).

Full Title of Study: “The Impact of a Fruit and Vegetable Provision Program on Cardiovascular Health”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 15, 2020

Interventions

  • Dietary Supplement: Fruit and vegetable deliveries
    • Weekly home deliveries of approximately 15 pounds of fresh fruits & vegetables

Arms, Groups and Cohorts

  • Experimental: Intervention Group
  • No Intervention: Control Group

Clinical Trial Outcome Measures

Primary Measures

  • Intake of fruits and vegetables measured by changes in Healthy Eating Index (HEI)
    • Time Frame: 6 months
    • The HEI uses a scoring system to evaluate a set of foods. The scores range from 0 to 100. An ideal overall HEI score of 100 reflects that the set of foods aligns with key dietary recommendations from the Dietary Guidelines for Americans.

Secondary Measures

  • Changes in weight measured by body mass index
    • Time Frame: 6 months
    • weight and height will be combined to report BMI in kg/m^2
  • Changes in waist circumference
    • Time Frame: 6 months
    • Waist circumference will be measured in inches using a tape measure; desirable: < 40 inches (men), < 35 inches (women)
  • Changes in total cholesterol
    • Time Frame: 6 months
    • measured via blood draw, desirable < 200 mg/dL
  • Changes in HDL-cholesterol
    • Time Frame: 6 months
    • measured via blood draw, desirable > 40 mg/dL
  • Changes in LDL-cholesterol
    • Time Frame: 6 months
    • measured via blood draw, desirable < 100 mg/dL
  • Changes in triglycerides
    • Time Frame: 6 months
    • measured via blood draw, desirable < 150 mg/dL
  • Changes in blood pressure
    • Time Frame: 6 months
    • Measured by medical assistant in clinic, desirable < 120/80 mmHg
  • Changes in blood glucose
    • Time Frame: 6 months
    • measured via blood draw, desirable range is 60-99 mg/dL

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Oregon Health and Science University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Tracy Severson, dietitian – Oregon Health and Science University
  • Overall Official(s)
    • Tracy Severson, RDN, Principal Investigator, Oregon Health and Science University

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