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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Atherosclerosis
• Intervention / Treatment: Behavioral: Mindfulness-based stress reduction; Behavioral: Nutrition Enhancement

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Montana
    • Bozeman, Montana, United States, 59717
      • Montana State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness-based stress reduction; Stress reduction class and behavioral intervention	Behavioral: Mindfulness-based stress reduction; Stress reduction class and behavioral intervention
Active Comparator: Nutrition Enhancement; Nutrition education class and behavioral intervention	Behavioral: Nutrition Enhancement; Nutrition education class and behavioral intervention
No Intervention: Control; 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

Collaborators and Investigators

• Sponsor: Montana State University
• Collaborators: American Heart Association

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: June 13, 2014
• First Submitted That Met QC Criteria: June 13, 2014
• First Posted (Estimate): June 17, 2014

Study Record Updates

• Last Update Posted (Estimate): June 17, 2014
• Last Update Submitted That Met QC Criteria: June 13, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis
• Other Study ID Numbers: 10GRNT260013