Atherosclerosis, Diabetes
Conditions
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.
Interventions
BEHAVIORALMindfulness-based stress reduction
Stress reduction class and behavioral intervention
BEHAVIORALNutrition Enhancement
Nutrition education class and behavioral intervention
Sponsors
American Heart Association
Montana State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inflammation Biomarkers | 16 weeks | C-reactive protein (CRP), tumor necrosis factor-alpha, interleukin-6 |
| Metabolic Syndrome Extent | 16 weeks | Blood pressure, waist circumference, fasting glucose, fasting HDL, fasting triglycerides, number of components |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cholesterol | 16 weeks | Fasting total cholesterol concentration |
| Insulin Resistance | 16 weeks | Fasting insulin concentration and homeostatic model assessment of insulin resistance (HOMA-IR) |
| Stress hormone levels | 16 weeks | Salivary cortisol concentration at 7 a.m., 12 and 4 p.m. |
| BMI | 16 weeks | BMI = weight/height squared |
| Depression | 16 weeks | Depression Score |
| Mindfulness | 16 weeks | Perception of mindfulness from subscale within the self-compassion scale questionnaire |
| Perceived Stress | 16 weeks | Score from the perceived stress scale. |
| Waist to hip ratio | 16 weeks | Circumference of the waist/circumference of the hips |
Countries
United States
Outcome results
None listed