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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Obesity; Cardiovascular Risk Factor
• Intervention / Treatment: Behavioral: Mediterranean diet; Dietary supplement: Olive oil and mixed nuts; Behavioral: American Heart Association

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Auburn, Alabama, United States, 36849
      • Auburn University Pharmaceutical Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mediterranean diet group; Participants will receive both nutrition education on patterns of a Mediterranean style diet as well as olive oil and mixed nuts.	Behavioral: 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.; Dietary supplement: 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.
Active Comparator: American Heart Association group; Participants will receive nutrition education on the dietary recommendations for heart health from the American Heart Association.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diastolic Blood Pressure Measurement	Measured in mmHg	Change from at baseline weight to 6-weeks
Change in Weight	Measured in kilograms (kg)	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)	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)	Change from baseline weight to 12-weeks
Concentration of fasted total cholesterol	Measured in mg/dL	Change from baseline weight to 6-weeks
Concentration of fasted total cholesterol	Measured in mg/dL	Change from baseline weight to 12-weeks
Concentration of fasted high-density lipoprotein (HDL) cholesterol	Measured in mg/dL	Change from baseline weight to 6-weeks
Concentration of fasted high-density lipoprotein (HDL) cholesterol	Measured in mg/dL	Change from baseline weight to 12-weeks
Concentration of fasted low-density lipoprotein (LDL) cholesterol	Measured in mg/dL	Change from baseline weight to 12-weeks
Concentration of fasted low-density lipoprotein (LDL) cholesterol	Measured in mg/dL	Change from baseline weight to 6-weeks
Concentration of fasted triglycerides	Measured in mg/dL	Change from baseline weight to 6-weeks
Concentration of fasted triglycerides	Measured in mg/dL	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	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	Change from baseline weight to 6-weeks
Concentration of fasted blood glucose	Measured in mg/dL	Change from baseline weight to 6-weeks
Concentration of fasted blood glucose	Measured in mg/dL	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	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	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.	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.	Change from baseline weight to 12-weeks

Collaborators and Investigators

• Sponsor: Auburn University
• Investigators: Study Chair: Michael W Greene, PhD, Auburn University; Principal Investigator: Amy W Willis, MS, RD, Auburn University

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2017
• Primary Completion (Actual): September 7, 2017
• Study Completion (Actual): September 7, 2017

Study Registration Dates

• First Submitted: September 20, 2018
• First Submitted That Met QC Criteria: September 21, 2018
• First Posted (Actual): September 25, 2018

Study Record Updates

• Last Update Posted (Actual): September 27, 2018
• Last Update Submitted That Met QC Criteria: September 26, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Cardiovascular Disease; Mediterranean Diet; Nutrition education
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: The Healthy Hearts Program

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No