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

September 26, 2018 updated by: Michael W. Greene, Auburn University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Systolic Blood Pressure Measurement
Time Frame: Change from at baseline blood pressure to 6-weeks
Measured in mmHg
Change from at baseline blood pressure to 6-weeks
Systolic Blood Pressure Measurement
Time Frame: Change from at baseline blood pressure to 12-weeks
Measured in mmHg
Change from at baseline blood pressure to 12-weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Diastolic Blood Pressure Measurement
Time Frame: Change from at baseline weight to 6-weeks
Measured in mmHg
Change from at baseline weight to 6-weeks
Change in Weight
Time Frame: Change from at baseline weight to 12-weeks
Measured in kilograms (kg)
Change from at baseline weight to 12-weeks
Calculation of Body Mass Index (BMI) (kg/m∧2)
Time Frame: Change from baseline weight to 6-weeks
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)
Time Frame: Change from baseline weight to 12-weeks
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
Time Frame: Change from baseline weight to 6-weeks
Measured in mg/dL
Change from baseline weight to 6-weeks
Concentration of fasted total cholesterol
Time Frame: Change from baseline weight to 12-weeks
Measured in mg/dL
Change from baseline weight to 12-weeks
Concentration of fasted high-density lipoprotein (HDL) cholesterol
Time Frame: Change from baseline weight to 6-weeks
Measured in mg/dL
Change from baseline weight to 6-weeks
Concentration of fasted high-density lipoprotein (HDL) cholesterol
Time Frame: Change from baseline weight to 12-weeks
Measured in mg/dL
Change from baseline weight to 12-weeks
Concentration of fasted low-density lipoprotein (LDL) cholesterol
Time Frame: Change from baseline weight to 12-weeks
Measured in mg/dL
Change from baseline weight to 12-weeks
Concentration of fasted low-density lipoprotein (LDL) cholesterol
Time Frame: Change from baseline weight to 6-weeks
Measured in mg/dL
Change from baseline weight to 6-weeks
Concentration of fasted triglycerides
Time Frame: Change from baseline weight to 6-weeks
Measured in mg/dL
Change from baseline weight to 6-weeks
Concentration of fasted triglycerides
Time Frame: Change from baseline weight to 12-weeks
Measured in mg/dL
Change from baseline weight to 12-weeks
A calculation of total cholesterol (mg/dL) to HDL (mg/dL) ratio
Time Frame: Change from baseline weight to 12-weeks
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
Time Frame: Change from baseline weight to 6-weeks
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
Time Frame: Change from baseline weight to 6-weeks
Measured in mg/dL
Change from baseline weight to 6-weeks
Concentration of fasted blood glucose
Time Frame: Change from baseline weight to 12-weeks
Measured in mg/dL
Change from baseline weight to 12-weeks
A calculation of waist (inches) to height (inches) ratio
Time Frame: Change from baseline weight to 12-weeks
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
Time Frame: Change from baseline weight to 6-weeks
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
Time Frame: Change from baseline weight to 6-weeks
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
Time Frame: Change from baseline weight to 12-weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Auburn University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Michael W Greene, PhD, Auburn University
  • Principal Investigator: Amy W Willis, MS, RD, Auburn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 23, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 7, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 7, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 27, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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