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

The Impact of a Fruit and Vegetable Provision Program on Cardiovascular Health

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).

Study Overview

• Status: Completed
• Conditions: Hyperlipidemias
• Intervention / Treatment: Dietary supplement: Fruit and vegetable deliveries

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group	Dietary supplement: Fruit and vegetable deliveries; Weekly home deliveries of approximately 15 pounds of fresh fruits & vegetables
No Intervention: Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intake of fruits and vegetables measured by changes in Healthy Eating Index (HEI)	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.	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: Tracy Severson, RDN, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2019
• Primary Completion (Actual): December 15, 2020
• Study Completion (Actual): December 15, 2020

Study Registration Dates

• First Submitted: July 23, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (Actual): July 30, 2019

Study Record Updates

• Last Update Posted (Actual): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 18, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: nutrition; diet; hyperlipidemia; produce
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias
• Other Study ID Numbers: 19413

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No