AtherosclerosisSICVDPNCT02165228
Strategies for Inflammation and Cardiovascular Disease (CVD) Prevention
A study testing Mindfulness-based stress reduction and Nutrition Enhancement in people with Atherosclerosis and Diabetes, run by Montana State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis, Diabetes
- What is being tested?
- Mindfulness-based stress reduction and Nutrition Enhancement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Elevated waist circumference or BMI
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Atherosclerosis, Diabetes
- Being tested
- Mindfulness-based stress reduction, Nutrition Enhancement
- Medical subject headings
- Atherosclerosis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based stress reductionBehavioural
Stress reduction class and behavioral intervention
Nutrition EnhancementBehavioural
Nutrition education class and behavioral intervention
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based stress reduction | Experimental | Stress reduction class and behavioral intervention Receives: Behavioral: Mindfulness-based stress reduction |
| Nutrition Enhancement | Active comparator | Nutrition education class and behavioral intervention Receives: Behavioral: Nutrition Enhancement |
| Control | No intervention | No class or behavioral intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammation Biomarkers
C-reactive protein (CRP), tumor necrosis factor-alpha, interleukin-6
Measured: 16 weeks
Metabolic Syndrome Extent
Blood pressure, waist circumference, fasting glucose, fasting HDL, fasting triglycerides, number of components
Measured: 16 weeks
Secondary outcomes (8)
BMI
BMI = weight/height squared
Measured: 16 weeks
Waist to hip ratio
Circumference of the waist/circumference of the hips
Measured: 16 weeks
Cholesterol
Fasting total cholesterol concentration
Measured: 16 weeks
Insulin Resistance
Fasting insulin concentration and homeostatic model assessment of insulin resistance (HOMA-IR)
Measured: 16 weeks
Stress hormone levels
Salivary cortisol concentration at 7 a.m., 12 and 4 p.m.
Measured: 16 weeks
Perceived Stress
Score from the perceived stress scale.
Measured: 16 weeks
Depression
Depression Score
Measured: 16 weeks
Mindfulness
Perception of mindfulness from subscale within the self-compassion scale questionnaire
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2014 (estimated)
- Study startJan 2010
- Primary completionMar 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montana State University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Mary Miles, Montana State University
- Investigators
- Mary P Miles, PhD, Principal investigator, Montana State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02165228
- Sponsor's protocol ID
- 10GRNT260013
- Acronym
- SICVDP
- Status last verified
- Jun 2014
- First submitted
- 13 Jun 2014
- Last updated
- 17 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Stress Reduction Strategy for Decreasing CVD Risk Through C-reactive Protein Reduction
- ClinicalTrials.gov ID
- NCT02165228
- Acronym / sponsor ID
- SICVDP / 10GRNT260013
- Conditions
- Atherosclerosis, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Montana State UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Jan 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 17 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based stress reduction | Experimental | Behavioral: Mindfulness-based stress reductionStress reduction class and behavioral intervention |
| Nutrition Enhancement | Active comparator | Behavioral: Nutrition EnhancementNutrition education class and behavioral intervention |
| Control | No intervention | –No class or behavioral intervention |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Elevated waist circumference or BMI
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based stress reductionStress reduction class and behavioral intervention | Behavioural | Mindfulness-based stress reduction |
| Nutrition EnhancementNutrition education class and behavioral intervention | Behavioural | Nutrition Enhancement |
Primary outcome
Inflammation Biomarkers
Time frame: 16 weeks
C-reactive protein (CRP), tumor necrosis factor-alpha, interleukin-6
Metabolic Syndrome Extent
Time frame: 16 weeks
Blood pressure, waist circumference, fasting glucose, fasting HDL, fasting triglycerides, number of components
8 secondary outcomes
BMI
Time frame: 16 weeks
Waist to hip ratio
Time frame: 16 weeks
Cholesterol
Time frame: 16 weeks
Insulin Resistance
Time frame: 16 weeks
Stress hormone levels
Time frame: 16 weeks
Perceived Stress
Time frame: 16 weeks
Depression
Time frame: 16 weeks
Mindfulness
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary P Miles, PhD principal investigator
Montana State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based stress reduction and Nutrition Enhancement in people with Atherosclerosis and Diabetes, run by Montana State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammation Biomarkers (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2014.