Mindfulness-based Personalized Health Planning for Reducing Risk of Heart Disease and Diabetes (AWARENESS)

February 23, 2017 updated by: Duke University
The purpose of this study is to compare the effectiveness of educational and lifestyle intervention programs aimed at reducing fasting blood sugar and emotional distress in adults with prediabetes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

There is a need for the development of new preventive strategies to help combat the rising prevalence of type 2 diabetes (T2D) and coronary heart disease (CHD). This need is particularly critical for individuals who already show impaired fasting glucose (IFG) which incurs a greater risk of T2D and CHD than those with normal glucose levels. Lifestyle changes are effective in reducing fasting glucose although changes in behaviors are challenging and may be more so among individuals with symptoms of depression. Evidence suggests that elevated symptoms of depression significantly impacts adiposity, levels of inflammatory biomarkers, and other early risk factors of cardiometabolic conditions. With few exceptions, current lifestyle interventions are 'one-size fits all' and pay little or no attention to patients' individual goals, resources, and barriers to making positive behavior changes with no lifestyle intervention addressing patients current mental states. By adopting a 'patient-centered' strategy, this study will test the effectiveness of a Mindfulness-based Personalized health planning (MB-PHP) in persons with prediabetes (e.g., defined by hemoglobin (h) A1c of 5.7%-6.4% and elevated symptoms of depression. The MB-PHP incorporates four primary strategies: (1) individual risk quantification of T2D and cardiovascular disease (CVD) based on hA1c and level of depressive symptoms; (2) group-based education on behavioral and traditional risk factors for CVD and T2D; (3) development of a personalized health plan (PHP) that emphasizes lifestyle areas where the patient is willing and ready to change; and (4) support in PHP implementation and patient engagement through integrative health partnering. To further support the goals of the PHP, mindfulness meditation is used to promote greater awareness of the unity of mind and body and specifically how unconscious thoughts, feelings, and behaviors can undermine achieving healthy lifestyle behaviors. The MB-PHP emphasizes personalize, predictive, and preventive risk management while fostering meaningful subject engagement with the goal of reducing fasting glucose and depressive symptom severity.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

1. Between 30 and 70 years old 2. Nonsmoker 3. Generally in good health 4. Able to speak and read English 5. Willing to provide informed consent 6. Patient Health Questionnaire-9 (PHQ-9) score greater than 5 (minimal depression) but less than 25 (severe depression) 7. Hemoglobin A1c values between 5.6%-6.4% (inclusive) 9. Able to attend 2 study visits at Duke University Medical Center 10. Able to attend 22 small group education sessions 11. Able to participate in 10 telephonic support sessions

Exclusion Criteria:

  1. Younger than 30 years old/Older than 70
  2. PHQ-9 score of 25 or greater (severe depression) and lower than 5 (no depression)

4. Hemoglobin A1c below 5.6% or above 6.4% 5. BMI less than 19.1 kg/m2 6. History of cardiovascular diseases (e.g., coronary artery disease, congestive heart failure, prior myocardial infarction or stroke, or more than 4 episodes of chest pain requiring nitroglycerin in the last month) 7. Current smokers or former smokers who quit within the last 6 months 8. Participation in formal group exercise, nutrition, weight loss or stress management program during the study period 9. Severe disease that may make cardiovascular prevention of secondary importance and/or result in severely compromised immune system (e.g., HIV positive, end-stage renal disease requiring dialysis, Hepatitis C) 10. Terminal illness defined as requiring oxygen or diagnosis of malignancy 11. Unstable medical conditions underlying weight or eating problems (e.g., Cushing's Syndrome, thyroid disorder) 12. Use of medications that impact immune, cardiovascular, or metabolic indices (e.g., anti-inflammatory, anti-hypertensives, lipid-lowering medications, oral agents for diabetes, stimulants) 13. Women on exogenous hormone replacement or oral contraceptives 14. Women reporting irregular menstrual cycle over previous 6 months 15. Severe psychiatric conditions or behaviors (e.g., drug or alcohol abuse, psychosis, severe social anxiety, bipolar disorder, Axis II diagnosis) 16. Unwillingness to accept randomization 17. Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MB-PHP Group
Mindfulness-based Personalized Health Planning (MB-PHP)with health coaching. MB-PHP includes weekly small group meetings for 22-weeks and 10 bi-weekly telephonic health coaching.
Behavioral: Mindfulness-based Personalized Health Planning
Other Names:
  • MB-PHP
Active Comparator: SAGE Group
Structure & Guided Education (SAGE) includes small group-education sessions once per week for 22 weeks. Subjects also participate in 10 bi-weekly telephone calls with education partners who use supportive listening techniques..
Other: Structured & Guided Education
Other Names:
  • SAGE

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fasting glucose
Time Frame: screening, up to 45-days after completion of intervention, long term follow-up (>6 months)
Changes from entry levels of fasting glucose up to 45-days post-intervention, and long-term follow-up (>6-months) levels.
screening, up to 45-days after completion of intervention, long term follow-up (>6 months)
Severity of depressive symptoms
Time Frame: baseline, up to 45-days after completion of intervention, long-term follow-up (>6 months)
Changes from entry levels of severity of depressive symptoms as assessed via the Hamilton Depression (HAM-D) interview to 45-days after completion of intervention and long-term follow-up (> 6-months)
baseline, up to 45-days after completion of intervention, long-term follow-up (>6 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Reduction in resting blood pressure
Time Frame: Baseline, up to 45-days after completion of intervention, long-term follow-up (>6 months)
Changes in systolic and diastolic blood pressure 45-days following completion of intervention and long-term follow-up.
Baseline, up to 45-days after completion of intervention, long-term follow-up (>6 months)
Changes in inflammation
Time Frame: baseline, 45-days following completion of intervention and long-term follow-up(>6-months)
Pre-to-post changes in inflammation as assessed by high sensitivity C-reactive protein (hsCRP) and in vitro production of stimulated cytokines 45-days following completion of intervention and long-term follow-up..
baseline, 45-days following completion of intervention and long-term follow-up(>6-months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Edward Suarez, Ph.D., Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 15, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 2, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00016540
  • R01HL067459 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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