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

Auburn University

Status: Completed

Conditions: Obesity; Cardiovascular Diseases; Cardiovascular Risk Factor

Treatments: Behavioral: Mediterranean diet; Behavioral: American Heart Association; Dietary Supplement: Olive oil and mixed nuts

Study type: Interventional

Funder types: Other

Identifiers

NCT03683134

The Healthy Hearts Program

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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58 participants in 2 patient groups

Mediterranean diet group

Experimental group

Description:

Participants will receive both nutrition education on patterns of a Mediterranean style diet as well as olive oil and mixed nuts.

Treatment:

Behavioral: Mediterranean diet

Dietary Supplement: Olive oil and mixed nuts

American Heart Association group

Active Comparator group

Description:

Participants will receive nutrition education on the dietary recommendations for heart health from the American Heart Association.

Treatment:

Behavioral: American Heart Association