The Impact of a Fruit and Vegetable Provision Program on Cardiovascular Health
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Intake of fruits and vegetables measured by changes in Healthy Eating Index (HEI)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Intake of fruits and vegetables measured by changes in Healthy Eating Index (HEI)
Time Frame: 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 Outcomes
- Changes in triglycerides(6 months)
- Changes in weight measured by body mass index(6 months)
- Changes in LDL-cholesterol(6 months)
- Changes in blood pressure(6 months)
- Changes in total cholesterol(6 months)
- Changes in HDL-cholesterol(6 months)
- Changes in waist circumference(6 months)
- Changes in blood glucose(6 months)
Investigators
Tracy Severson
dietitian
Oregon Health and Science University