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NCT02165228 · ClinicalTrials.gov registry record · NA
Strategies for Inflammation and Cardiovascular Disease (CVD) Prevention
A NA study, sponsored by Montana State University.
- Completed
- Registry status
- NA
- Development phase
- 108
- Enrollment target
NCT02165228 is a NA study that has completed, run by Montana State University. The registered enrollment target is 108 participants.
The verdict
NCT02165228, a NA study, has completed, sponsored by Montana State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 108 participants
- Enrollment target
Study 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
- BEHAVIORAL Mindfulness-based stress reduction
- BEHAVIORAL Nutrition Enhancement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2010-01 |
| Est. Completion | 2012-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02165228
The ClinicalTrials.gov registry entry for NCT02165228 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Montana State University, which has 36 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Mindfulness-based stress reduction is the first listed.
NCT02165228 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02165228 about?
NCT02165228 is a clinical study titled "Strategies for Inflammation and Cardiovascular Disease (CVD) Prevention". 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 ...
What is the current status of trial NCT02165228?
This trial is currently completed. It is a NA study. The enrollment target is 108 participants. The study started on 2010-01. Estimated completion is 2012-12.
What interventions are being tested in trial NCT02165228?
The interventions under investigation include: Mindfulness-based stress reduction (BEHAVIORAL), Nutrition Enhancement (BEHAVIORAL).
Who is sponsoring clinical trial NCT02165228?
This trial is sponsored by Montana State University, which has 36 total clinical trials registered on ClinicalTrials.gov.
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