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



Status:Completed
Conditions:Obesity Weight Loss, Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology
Healthy:No
Age Range:19 - Any
Updated:9/29/2018
Start Date:January 23, 2017
End Date:September 7, 2017

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A Pilot, Theory-Based, Nutrition Intervention Promoting a Mediterranean Diet for the Reduction of Cardiovascular Disease Risk Factors in a High-Risk Population of the Southeastern United States: The Healthy Hearts Program (HHP)

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.


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
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