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

NCT03683134 | Completed

• 1 other identifier: The Healthy Hearts Program
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Diseases; Cardiovascular Risk Factor; Obesity

Keywords

Cardiovascular Disease; Mediterranean Diet; Nutrition education

Outcome Measures

Primary Outcomes (2)

• Systolic Blood Pressure Measurement

  Measured in mmHg

  Change from at baseline blood pressure to 6-weeks

• Systolic Blood Pressure Measurement

  Measured in mmHg

  Change from at baseline blood pressure to 12-weeks

Secondary Outcomes (20)

• Diastolic Blood Pressure Measurement

  Change from at baseline weight to 6-weeks

• Change in Weight

  Change from at baseline weight to 12-weeks

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

  Change from baseline weight to 6-weeks

• Calculation of BMI (kg/m∧2)

  Change from baseline weight to 12-weeks

• Concentration of fasted total cholesterol

  Change from baseline weight to 6-weeks

Study Arms (2)

Mediterranean diet group

EXPERIMENTAL

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

Behavioral: Mediterranean diet; Dietary Supplement: Olive oil and mixed nuts

American Heart Association group

ACTIVE COMPARATOR

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

Behavioral: American Heart Association

Interventions

Mediterranean diet BEHAVIORAL

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.

Mediterranean diet group

Olive oil and mixed nuts DIETARY_SUPPLEMENT

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.

Mediterranean diet group

American Heart Association BEHAVIORAL

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.

American Heart Association group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Auburn University: lead

Study Sites (1)

Auburn University Pharmaceutical Care Center

Auburn, Alabama, 36849, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Obesity

Interventions

Diet, Mediterranean; Olive Oil; American Heart Association

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Food and Beverages; Voluntary Health Agencies; Organizations, Nonprofit; Organizations; Health Care Economics and Organizations

Study Officials

• Michael W Greene, PhD

  Auburn University

  STUDY CHAIR

• Amy W Willis, MS, RD

  Auburn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Auburn University Metabolic Phenotyping Laboratory

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 25, 2018
• Study Start: January 23, 2017
• Primary Completion: September 7, 2017
• Study Completion: September 7, 2017
• Last Updated: September 27, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)