Strategies for Inflammation and Cardiovascular Disease (CVD) Prevention (SICVDP)
Primary Purpose
Atherosclerosis, Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-based stress reduction
Nutrition Enhancement
Sponsored by
About this trial
This is an interventional prevention trial for Atherosclerosis
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
Sites / Locations
- Montana State University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Mindfulness-based stress reduction
Nutrition Enhancement
Control
Arm Description
Stress reduction class and behavioral intervention
Nutrition education class and behavioral intervention
No class or behavioral intervention
Outcomes
Primary Outcome Measures
Inflammation Biomarkers
C-reactive protein (CRP), tumor necrosis factor-alpha, interleukin-6
Metabolic Syndrome Extent
Blood pressure, waist circumference, fasting glucose, fasting HDL, fasting triglycerides, number of components
Secondary Outcome Measures
BMI
BMI = weight/height squared
Waist to hip ratio
Circumference of the waist/circumference of the hips
Cholesterol
Fasting total cholesterol concentration
Insulin Resistance
Fasting insulin concentration and homeostatic model assessment of insulin resistance (HOMA-IR)
Stress hormone levels
Salivary cortisol concentration at 7 a.m., 12 and 4 p.m.
Perceived Stress
Score from the perceived stress scale.
Depression
Depression Score
Mindfulness
Perception of mindfulness from subscale within the self-compassion scale questionnaire
Full Information
NCT ID
NCT02165228
First Posted
June 13, 2014
Last Updated
June 13, 2014
Sponsor
Montana State University
Collaborators
American Heart Association
1. Study Identification
Unique Protocol Identification Number
NCT02165228
Brief Title
Strategies for Inflammation and Cardiovascular Disease (CVD) Prevention
Acronym
SICVDP
Official Title
A Stress Reduction Strategy for Decreasing CVD Risk Through C-reactive Protein Reduction
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montana State University
Collaborators
American Heart Association
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis, Diabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness-based stress reduction
Arm Type
Experimental
Arm Description
Stress reduction class and behavioral intervention
Arm Title
Nutrition Enhancement
Arm Type
Active Comparator
Arm Description
Nutrition education class and behavioral intervention
Arm Title
Control
Arm Type
No Intervention
Arm Description
No class or behavioral intervention
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based stress reduction
Intervention Description
Stress reduction class and behavioral intervention
Intervention Type
Behavioral
Intervention Name(s)
Nutrition Enhancement
Intervention Description
Nutrition education class and behavioral intervention
Primary Outcome Measure Information:
Title
Inflammation Biomarkers
Description
C-reactive protein (CRP), tumor necrosis factor-alpha, interleukin-6
Time Frame
16 weeks
Title
Metabolic Syndrome Extent
Description
Blood pressure, waist circumference, fasting glucose, fasting HDL, fasting triglycerides, number of components
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
BMI
Description
BMI = weight/height squared
Time Frame
16 weeks
Title
Waist to hip ratio
Description
Circumference of the waist/circumference of the hips
Time Frame
16 weeks
Title
Cholesterol
Description
Fasting total cholesterol concentration
Time Frame
16 weeks
Title
Insulin Resistance
Description
Fasting insulin concentration and homeostatic model assessment of insulin resistance (HOMA-IR)
Time Frame
16 weeks
Title
Stress hormone levels
Description
Salivary cortisol concentration at 7 a.m., 12 and 4 p.m.
Time Frame
16 weeks
Title
Perceived Stress
Description
Score from the perceived stress scale.
Time Frame
16 weeks
Title
Depression
Description
Depression Score
Time Frame
16 weeks
Title
Mindfulness
Description
Perception of mindfulness from subscale within the self-compassion scale questionnaire
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary P Miles, PhD
Organizational Affiliation
Montana State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montana State University
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59717
Country
United States
12. IPD Sharing Statement
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Strategies for Inflammation and Cardiovascular Disease (CVD) Prevention
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