A Mediterranean Diet Nutrition Education Program for the Reduction of Cardiovascular Disease Risk in the Southeastern U.S.
NCT ID: NCT03683134
Last Updated: 2018-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
58 participants
INTERVENTIONAL
2017-01-23
2017-09-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Mediterranean diet group
Participants will receive both nutrition education on patterns of a Mediterranean style diet as well as olive oil and mixed nuts.
Mediterranean diet
Participants will receive nutrition education and educational materials from a registered dietitian on patients on the patterns of a Mediterranean style diet. Seven education sessions will be delivered through an online platform. Participants will be asked to complete one education session per week for the first six weeks and the final session at week 9.
Olive oil and mixed nuts
Participants in the Mediterranean diet group will receive 3 liters of extra-virgin olive oil and 3 pounds of mixed nuts (1.5 pounds raw almonds and 1.5 pounds raw walnuts) at baseline and at 6 weeks. Participants will be educated by oral and written means, on consumption goals of the nuts and olive oil.
American Heart Association group
Participants will receive nutrition education on the dietary recommendations for heart health from the American Heart Association.
American Heart Association
Participants will receive nutrition education and educational materials from a registered dietitian on patients on the dietary recommendations from the American Heart Association for heart health. Seven education sessions will be delivered through an online platform. Participants will be asked to complete one education session per week for the first six weeks and the final session at week 9.
Interventions
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Mediterranean diet
Participants will receive nutrition education and educational materials from a registered dietitian on patients on the patterns of a Mediterranean style diet. Seven education sessions will be delivered through an online platform. Participants will be asked to complete one education session per week for the first six weeks and the final session at week 9.
Olive oil and mixed nuts
Participants in the Mediterranean diet group will receive 3 liters of extra-virgin olive oil and 3 pounds of mixed nuts (1.5 pounds raw almonds and 1.5 pounds raw walnuts) at baseline and at 6 weeks. Participants will be educated by oral and written means, on consumption goals of the nuts and olive oil.
American Heart Association
Participants will receive nutrition education and educational materials from a registered dietitian on patients on the dietary recommendations from the American Heart Association for heart health. Seven education sessions will be delivered through an online platform. Participants will be asked to complete one education session per week for the first six weeks and the final session at week 9.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
ALL
No
Sponsors
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Auburn University
OTHER
Responsible Party
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Michael W. Greene
Director, Auburn University Metabolic Phenotyping Laboratory
Principal Investigators
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Michael W Greene, PhD
Role: STUDY_CHAIR
Auburn University
Amy W Willis, MS, RD
Role: PRINCIPAL_INVESTIGATOR
Auburn University
Locations
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Auburn University Pharmaceutical Care Center
Auburn, Alabama, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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The Healthy Hearts Program
Identifier Type: -
Identifier Source: org_study_id
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