Strategies for Inflammation and Cardiovascular Disease (CVD) Prevention

Study Overview
=================
Brief Summary
-----------------
The long-term goal of the proposed research is to identify and develop effective interventions to decrease persistent, low-level inflammation and risk of CVD. Stress is a substantial contributor to inflammation, and interactions among stress, inflammation, body mass index, and health behaviors have been measured. Mindfulness-based stress reduction (MBSR) is effective for stress reduction, has been shown to be effective for inflammation reduction in individuals with disease, and is a sustainable practice for individuals across the health spectrum. Diet strategies are an effective means of reducing inflammation for some individuals, but may not be successful for many people, as evidenced by the steady rise in obesity rates. The specific aims of this study are to 1) test the effectiveness of MBSR compared to an established intervention of a nutrition enhancement (NE) intervention for the reduction of inflammation, and 2) test the effectiveness of MBSR compared to a non-intervention control conditions (CON) for the reduction of inflammation. Men and women 25-45 years of age will be randomly assigned to participate in MBSR (n=60) or DIET (n=60) or CON (n=60) interventions for 16 weeks. Serum CRP concentrations, additional inflammatory cytokines (tumor necrosis factor-a, interleukin-6), cortisol diurnal profiles, anthropometrics, dietary intake, and all components of the metabolic syndrome will be measured pre- and post-intervention to elucidate underlying mechanisms and to determine whether health benefits beyond inflammation reduction occur.

Official Title
-----------------
A Stress Reduction Strategy for Decreasing CVD Risk Through C-reactive Protein Reduction

Conditions
-----------------
Atherosclerosis, Diabetes

Intervention / Treatment
-----------------
* Behavioral: Mindfulness-based stress reduction
* Behavioral: Nutrition Enhancement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elevated waist circumference or BMI Exclusion Criteria: Participation in calorie restricted diet in previous 30 d Participation in stress reduction program in previous 30 d Take blood pressure, lipid lowering or anti-inflammatory medications Hypertension Diabetes Heart disease

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-based stress reduction<br>Stress reduction class and behavioral intervention | Behavioral: Mindfulness-based stress reduction<br>* Stress reduction class and behavioral intervention<br>|
| Active Comparator: Nutrition Enhancement<br>Nutrition education class and behavioral intervention | Behavioral: Nutrition Enhancement<br>* Nutrition education class and behavioral intervention<br>|
| No Intervention: Control<br>No class or behavioral intervention | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammation Biomarkers | C-reactive protein (CRP), tumor necrosis factor-alpha, interleukin-6 | 16 weeks | 
| Metabolic Syndrome Extent | Blood pressure, waist circumference, fasting glucose, fasting HDL, fasting triglycerides, number of components | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI | BMI = weight/height squared | 16 weeks | 
| Waist to hip ratio | Circumference of the waist/circumference of the hips | 16 weeks | 
| Cholesterol | Fasting total cholesterol concentration | 16 weeks | 
| Insulin Resistance | Fasting insulin concentration and homeostatic model assessment of insulin resistance (HOMA-IR) | 16 weeks | 
| Stress hormone levels | Salivary cortisol concentration at 7 a.m., 12 and 4 p.m. | 16 weeks | 
| Perceived Stress | Score from the perceived stress scale. | 16 weeks | 
| Depression | Depression Score | 16 weeks | 
| Mindfulness | Perception of mindfulness from subscale within the self-compassion scale questionnaire | 16 weeks |