Strategies for Inflammation and Cardiovascular Disease (CVD) Prevention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Atherosclerosis Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Mindfulness-based stress reduction

Stress reduction class and behavioral intervention

Group Type EXPERIMENTAL

Mindfulness-based stress reduction

Intervention Type BEHAVIORAL

Stress reduction class and behavioral intervention

Nutrition Enhancement

Nutrition education class and behavioral intervention

Group Type ACTIVE_COMPARATOR

Nutrition Enhancement

Intervention Type BEHAVIORAL

Nutrition education class and behavioral intervention

Control

No class or behavioral intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mindfulness-based stress reduction

Stress reduction class and behavioral intervention

Intervention Type BEHAVIORAL

Nutrition Enhancement

Nutrition education class and behavioral intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes