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

Not Applicable

Completed

• Conditions: Hyperlipidemias
• Interventions: Dietary Supplement: Fruit and vegetable deliveries

• Registration Number: NCT04036773
• Lead Sponsor: Oregon Health and Science University

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-23
• Study First Submitted QC: 2019-07-25
• Study First Posted: 2019-07-30
• Study Start: 2019-10-14
• Primary Completion: 2020-12-15
• Study Completion: 2020-12-15
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-18
• Last Update Posted: 2022-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Fruit and vegetable deliveries	-

Primary Outcome Measures

Name	Time	Method
Intake of fruits and vegetables measured by changes in Healthy Eating Index (HEI)	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 Outcome Measures

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

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States