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)

Auburn University1 site in 1 country58 target enrollmentJanuary 23, 2017

ConditionsCardiovascular Diseases Cardiovascular Risk Factor Obesity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cardiovascular Diseases
Sponsor: Auburn University
Enrollment: 58
Locations: 1
Primary Endpoint: Systolic Blood Pressure Measurement
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 23, 2017

End Date

September 7, 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Auburn University

Responsible Party

Principal Investigator

Michael W. Greene

Director, Auburn University Metabolic Phenotyping Laboratory

Auburn University

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Systolic Blood Pressure Measurement

Time Frame: Change from at baseline blood pressure to 12-weeks

Measured in mmHg

Secondary Outcomes

Change in Weight(Change from at baseline weight to 12-weeks)
Diastolic Blood Pressure Measurement(Change from at baseline weight to 6-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 12-weeks)
Concentration of fasted low-density lipoprotein (LDL) cholesterol(Change from baseline weight to 6-weeks)
Concentration of fasted blood glucose(Change from baseline weight to 12-weeks)
Concentration of fasted high-density lipoprotein (HDL) cholesterol(Change from baseline weight to 12-weeks)
Concentration of fasted triglycerides(Change from baseline weight to 12-weeks)
A calculation of total cholesterol (mg/dL) to HDL (mg/dL) ratio(Change from baseline weight to 6-weeks)
A calculation of waist (inches) to height (inches) 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(Change from baseline weight to 12-weeks)