Hyperlipidemias
Conditions
Keywords
diet, nutrition, hyperlipidemia, produce
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).
Interventions
DIETARY_SUPPLEMENTFruit and vegetable deliveries
Weekly home deliveries of approximately 15 pounds of fresh fruits & vegetables
Sponsors
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 weight measured by body mass index | 6 months | weight and height will be combined to report BMI in kg/m\^2 |
| 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 blood glucose | 6 months | measured via blood draw, desirable range is 60-99 mg/dL |
| Changes in LDL-cholesterol | 6 months | measured via blood draw, desirable \< 100 mg/dL |
Countries
United States
Outcome results
None listed