A Mediterranean Diet Nutrition Education Program for the Reduction of Cardiovascular Disease Risk in the Southeastern U.S.

Auburn University58 enrolled

Overview

A 12-week, randomized nutrition intervention for the reduction of cardiovascular disease risk factors in a high-risk population in the southeastern United States. The primary objective of this pilot study was to assess the efficacy of a Mediterranean diet intervention (education + extra-virgin olive oil (EVOO) and mixed nut supplementation) versus that of an American Heart Association (AHA) nutrition intervention (education) on serum blood lipid levels as markers for cardiovascular disease risk. Researchers conducting this trial hypothesize that a greater reduction will be seen in cardiovascular disease risk factors in the Mediterranean diet intervention.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Cardiovascular Diseases Cardiovascular Risk Factor Obesity

Interventions

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Enrolled in Auburn University's health insurance program during the course of the study or a dependent of the enrollee during the course of the study * BMI \>24.9 (kg/m2) * AND Meets two or more of the following * Screening values classified in the "yellow" or "red" zone for: * Systolic blood pressure (mmHg): Yellow zone: ≥140, Red zone: ≥160; * Diastolic Blood pressure (mmHg): Yellow zone: ≥90, Red zone: ≥ 100; * Fasting blood glucose (mm/dL): Yellow zone: ≥100, Red zone: ≥ 126 * Blood glucose (random) (mg/dL): Yellow zone: 140-200, Red zone \> 200 * Total Cholesterol (mg/dL): Yellow zone: ≥200, red zone: ≥250 * Have a pre-existing diagnosis of hypertension, pre-diabetes, or hypercholesterolemia * Current smoker (≥1 cigarette/day) * Are: male (age: 55-80) or female (age: 60-80) * A family history of premature coronary heart disease * High risk ethnicity: Black, African American, American Indians/Alaska Natives, Non-Hispanic blacks, Mexican-Americans, Asian, Hispanic/Latino Exclusion Criteria: * Minors that are less than 19 years of age * Individuals who are not enrolled in the Auburn University health insurance program for the 2016 plan year at baseline and have not yet completed initial visit * Individuals who have not completed their 2015 "Healthy Tigers" biometric screening between January 1st and December 31st, 2015 (these can be completed by the "Healthy Tigers" staff or by submitting a healthcare provider form from the individuals' physician to the "Healthy Tigers" office), unless enrolled in "TigerMeds". * Individuals who are pregnant or who intend to become pregnant during the 12-week health and wellness challenge. * Individuals who anticipate absence or travel throughout the study that would interfere with their ability to complete the analysis at the mid-point and end of challenge. * Patients with a peanut, tree nut, or olive oil food allergy or intolerance. * Patients who are unable or unwilling to travel to Auburn University main campus for live health and wellness challenge events, individual assessments, personal appointments, and pre- and post- data collection * Individuals who have NOT been stabilized on medication to treat or manage high blood pressure, high cholesterol, dyslipidemia, or pre diabetes for at least 12 weeks prior to the study. * Patients who do not have access to the internet and therefore unable to complete the education portion of the study * Individuals who have a pacemaker * Patients who decline participation during informed consent

Outcomes

Primary Outcomes

Systolic Blood Pressure Measurement

Measured in mmHg

Time frame: Change from at baseline blood pressure to 6-weeks

Systolic Blood Pressure Measurement

Measured in mmHg

Time frame: Change from at baseline blood pressure to 12-weeks

Secondary Outcomes

Diastolic Blood Pressure Measurement

Measured in mmHg

Time frame: Change from at baseline weight to 6-weeks

Change in Weight

Measured in kilograms (kg)

Time frame: Change from at baseline weight to 12-weeks

Calculation of Body Mass Index (BMI) (kg/m∧2)

Height in meters will be combined with weight in kilograms will be combined to report BMI in kg/m∧2)

Time frame: Change from baseline weight to 6-weeks

Calculation of BMI (kg/m∧2)

Height in meters will be combined with weight in kilograms will be combined to report BMI in kg/m∧2)

Time frame: Change from baseline weight to 12-weeks

Concentration of fasted total cholesterol

Measured in mg/dL

Time frame: Change from baseline weight to 6-weeks

Concentration of fasted total cholesterol

Measured in mg/dL

Time frame: Change from baseline weight to 12-weeks

Concentration of fasted high-density lipoprotein (HDL) cholesterol

Measured in mg/dL

Time frame: Change from baseline weight to 6-weeks

Concentration of fasted high-density lipoprotein (HDL) cholesterol

Measured in mg/dL

Time frame: Change from baseline weight to 12-weeks

Concentration of fasted low-density lipoprotein (LDL) cholesterol

Measured in mg/dL

Time frame: Change from baseline weight to 12-weeks

Concentration of fasted low-density lipoprotein (LDL) cholesterol

Measured in mg/dL

Time frame: Change from baseline weight to 6-weeks

Concentration of fasted triglycerides

Measured in mg/dL

Time frame: Change from baseline weight to 6-weeks

Concentration of fasted triglycerides

Measured in mg/dL

Time frame: Change from baseline weight to 12-weeks

A calculation of total cholesterol (mg/dL) to HDL (mg/dL) ratio

Total cholesterol (mg/dL) will be used with HDL (mg/dL) to calculate total cholesterol to HDL ratio

Time frame: Change from baseline weight to 12-weeks

A calculation of total cholesterol (mg/dL) to HDL (mg/dL) ratio

Total cholesterol (mg/dL) will be used with HDL (mg/dL) to calculate total cholesterol to HDL ratio

Time frame: Change from baseline weight to 6-weeks

Concentration of fasted blood glucose

Measured in mg/dL

Time frame: Change from baseline weight to 6-weeks

Concentration of fasted blood glucose

Measured in mg/dL

Time frame: Change from baseline weight to 12-weeks

A calculation of waist (inches) to height (inches) ratio

Waist circumference in inches will be calculated with height measurement in inches to report the waist-to-height ratio

Time frame: Change from baseline weight to 12-weeks

A calculation of waist (inches) to height (inches) ratio

Waist circumference in inches will be calculated with height measurement in inches to report the waist-to-height ratio

Time frame: Change from baseline weight to 6-weeks

Calculation of homeostatic model assessment (HOMA)-insulin resistance (IR) from fasted blood concentrations of fasted blood glucose and fasted insulin

Fasting plasma glucose in mg/dL and fasting serum insulin in milliUnits (mU)/I will be used to calculate HOMA-IR as an indicator for insulin resistance.

Time frame: Change from baseline weight to 6-weeks

Calculation of homeostatic model assessment (HOMA)-insulin resistance (IR) from fasted blood concentrations of fasted blood glucose and fasted insulin

Fasting plasma glucose in mg/dL and fasting serum insulin in mU/I will be used to calculate HOMA-IR as an indicator for insulin resistance.

Time frame: Change from baseline weight to 12-weeks

A Mediterranean Diet Nutrition Education Program for the Reduction of Cardiovascular Disease Risk in the Southeastern U.S.

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes