Strategies for Inflammation and Cardiovascular Disease (CVD) Prevention (SICVDP)

Montana State University

Status: Completed

Conditions: Diabetes; Atherosclerosis

Treatments: Behavioral: Mindfulness-based stress reduction; Behavioral: Nutrition Enhancement

Study type: Interventional

Funder types: Other

Identifiers

NCT02165228

10GRNT260013

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 25 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 3 patient groups

Mindfulness-based stress reduction

Experimental group

Description:

Stress reduction class and behavioral intervention

Treatment:

Behavioral: Mindfulness-based stress reduction

Nutrition Enhancement

Active Comparator group

Description:

Nutrition education class and behavioral intervention

Treatment:

Behavioral: Nutrition Enhancement

Control

No Intervention group

Description:

No class or behavioral intervention