Mindfulness-based Personalized Health Planning for Reducing Risk of Heart Disease and Diabetes (AWARENESS)
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ClinicalTrials.gov Identifier: NCT01430221 |
Recruitment Status :
Completed
First Posted : September 8, 2011
Last Update Posted : February 24, 2017
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Condition or disease | Intervention/treatment | Phase |
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Prediabetes Depressive Symptoms Mild to Moderate in Severity | Behavioral: Mindfulness-based Personalized Health Planning Other: Structured & Guided Education | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 140 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Mindfulness-based Personalized Health Planning for Reducing Risk of Heart Disease and Diabetes |
Study Start Date : | May 2011 |
Actual Primary Completion Date : | February 15, 2017 |
Actual Study Completion Date : | February 15, 2017 |

Arm | Intervention/treatment |
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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.
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Behavioral: Mindfulness-based Personalized Health Planning
Other Name: 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..
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Other: Structured & Guided Education
Other Name: SAGE |
- 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.
- 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)
- 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.
- 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..

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Ages Eligible for Study: | 30 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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:
- Younger than 30 years old/Older than 70
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01430221
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 |
Principal Investigator: | Edward Suarez, Ph.D. | Duke University |
Responsible Party: | Duke University |
ClinicalTrials.gov Identifier: | NCT01430221 |
Other Study ID Numbers: |
Pro00016540 R01HL067459 ( U.S. NIH Grant/Contract ) |
First Posted: | September 8, 2011 Key Record Dates |
Last Update Posted: | February 24, 2017 |
Last Verified: | February 2017 |
prediabetes severity of depressive symptoms mindfulness personalized health planning cardiometabolic diseases prevention |
Heart Diseases Prediabetic State Glucose Intolerance Depression Cardiovascular Diseases Diabetes Mellitus |
Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Hyperglycemia Behavioral Symptoms |