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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Systolic Blood Pressure Measurement
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Mediterranean diet group
Participants will receive both nutrition education on patterns of a Mediterranean style diet as well as olive oil and mixed nuts.
干预措施: Mediterranean diet (Behavioral)
Mediterranean diet group
Participants will receive both nutrition education on patterns of a Mediterranean style diet as well as olive oil and mixed nuts.
干预措施: Olive oil and mixed nuts (Dietary Supplement)
American Heart Association group
Participants will receive nutrition education on the dietary recommendations for heart health from the American Heart Association.
干预措施: American Heart Association (Behavioral)
结局指标
主要结局
Systolic Blood Pressure Measurement
时间窗: Change from at baseline blood pressure to 12-weeks
Measured in mmHg
次要结局
- 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)
研究者
Michael W. Greene
Director, Auburn University Metabolic Phenotyping Laboratory
Auburn University