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

Primary Purpose

Hyperlipidemias

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fruit and vegetable deliveries
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperlipidemias focused on measuring diet, nutrition, hyperlipidemia, produce

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Oregon Health & Science University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 23, 2019
Last Updated
April 18, 2022
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT04036773
Brief Title
Food Pharmacy at Oregon Health & Science University (OHSU) Knight Cardiovascular Institute (KCVI)
Official Title
The Impact of a Fruit and Vegetable Provision Program on Cardiovascular Health
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 14, 2019 (Actual)
Primary Completion Date
December 15, 2020 (Actual)
Study Completion Date
December 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemias
Keywords
diet, nutrition, hyperlipidemia, produce

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
No Intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Fruit and vegetable deliveries
Intervention Description
Weekly home deliveries of approximately 15 pounds of fresh fruits & vegetables
Primary Outcome Measure Information:
Title
Intake of fruits and vegetables measured by changes in Healthy Eating Index (HEI)
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Changes in weight measured by body mass index
Description
weight and height will be combined to report BMI in kg/m^2
Time Frame
6 months
Title
Changes in waist circumference
Description
Waist circumference will be measured in inches using a tape measure; desirable: < 40 inches (men), < 35 inches (women)
Time Frame
6 months
Title
Changes in total cholesterol
Description
measured via blood draw, desirable < 200 mg/dL
Time Frame
6 months
Title
Changes in HDL-cholesterol
Description
measured via blood draw, desirable > 40 mg/dL
Time Frame
6 months
Title
Changes in LDL-cholesterol
Description
measured via blood draw, desirable < 100 mg/dL
Time Frame
6 months
Title
Changes in triglycerides
Description
measured via blood draw, desirable < 150 mg/dL
Time Frame
6 months
Title
Changes in blood pressure
Description
Measured by medical assistant in clinic, desirable < 120/80 mmHg
Time Frame
6 months
Title
Changes in blood glucose
Description
measured via blood draw, desirable range is 60-99 mg/dL
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tracy Severson, RDN
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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