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

NCT04036773 | Completed

• 1 other identifier: 19413
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Hyperlipidemias

Keywords

diet; nutrition; hyperlipidemia; produce

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Changes in weight measured by body mass index

  6 months

• Changes in waist circumference

  6 months

• Changes in total cholesterol

  6 months

• Changes in HDL-cholesterol

  6 months

• Changes in LDL-cholesterol

  6 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Dietary Supplement: Fruit and vegetable deliveries

Control Group

NO INTERVENTION

Interventions

Fruit and vegetable deliveries DIETARY_SUPPLEMENT

Weekly home deliveries of approximately 15 pounds of fresh fruits \& vegetables

Intervention Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Fruit

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Tracy Severson, RDN

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dietitian

Study Record Dates

• First Submitted: July 23, 2019
• First Posted: July 30, 2019
• Study Start: October 14, 2019
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)