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

Study Overview
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Brief Summary
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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).

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

Conditions
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Hyperlipidemias

Intervention / Treatment
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* Dietary Supplement: Fruit and vegetable deliveries


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br> | Dietary Supplement: Fruit and vegetable deliveries<br>* Weekly home deliveries of approximately 15 pounds of fresh fruits & vegetables<br>|
| No Intervention: Control Group<br> | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diet, nutrition, hyperlipidemia, produce