Clinical trial NCT03683134: A Mediterranean Diet Nutrition Education Program for the Reduction of Cardiovascular Disease Risk in the Southeastern U.S.
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Cardiovascular Risk Factor
Obesity
Keywords: Cardiovascular Disease
Mediterranean Diet
Nutrition education
Lead sponsor: Auburn University
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 58
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* 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

Primary outcomes:
measure: Systolic Blood Pressure Measurement
timeFrame: Change from at baseline blood pressure to 6-weeks
measure: Systolic Blood Pressure Measurement
timeFrame: Change from at baseline blood pressure to 12-weeks
Secondary outcomes:
measure: Diastolic Blood Pressure Measurement
timeFrame: Change from at baseline weight to 6-weeks
measure: Change in Weight
timeFrame: Change from at baseline weight to 12-weeks
measure: Calculation of Body Mass Index (BMI) (kg/m∧2)
timeFrame: Change from baseline weight to 6-weeks
measure: Calculation of BMI (kg/m∧2)
timeFrame: Change from baseline weight to 12-weeks
measure: Concentration of fasted total cholesterol
timeFrame: Change from baseline weight to 6-weeks
measure: Concentration of fasted total cholesterol
timeFrame: Change from baseline weight to 12-weeks
measure: Concentration of fasted high-density lipoprotein (HDL) cholesterol
timeFrame: Change from baseline weight to 6-weeks
measure: Concentration of fasted high-density lipoprotein (HDL) cholesterol
timeFrame: Change from baseline weight to 12-weeks
measure: Concentration of fasted low-density lipoprotein (LDL) cholesterol
timeFrame: Change from baseline weight to 12-weeks
measure: Concentration of fasted low-density lipoprotein (LDL) cholesterol
timeFrame: Change from baseline weight to 6-weeks
measure: Concentration of fasted triglycerides
timeFrame: Change from baseline weight to 6-weeks
measure: Concentration of fasted triglycerides
timeFrame: Change from baseline weight to 12-weeks
measure: A calculation of total cholesterol (mg/dL) to HDL (mg/dL) ratio
timeFrame: Change from baseline weight to 12-weeks
measure: A calculation of total cholesterol (mg/dL) to HDL (mg/dL) ratio
timeFrame: Change from baseline weight to 6-weeks
measure: Concentration of fasted blood glucose
timeFrame: Change from baseline weight to 6-weeks
measure: Concentration of fasted blood glucose
timeFrame: Change from baseline weight to 12-weeks
measure: A calculation of waist (inches) to height (inches) ratio
timeFrame: Change from baseline weight to 12-weeks
measure: A calculation of waist (inches) to height (inches) ratio
timeFrame: Change from baseline weight to 6-weeks
measure: Calculation of homeostatic model assessment (HOMA)-insulin resistance (IR) from fasted blood concentrations of fasted blood glucose and fasted insulin
timeFrame: Change from baseline weight to 6-weeks
measure: Calculation of homeostatic model assessment (HOMA)-insulin resistance (IR) from fasted blood concentrations of fasted blood glucose and fasted insulin
timeFrame: Change from baseline weight to 12-weeks
Other outcomes:
Locations:
city: Auburn
country: United States
facility: Auburn University Pharmaceutical Care Center
state: Alabama
Study officials:
affiliation: Auburn University
name: Michael W Greene, PhD
role: STUDY_CHAIR
affiliation: Auburn University
name: Amy W Willis, MS, RD
role: PRINCIPAL_INVESTIGATOR
References: