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

• ClinicalTrials.gov Identifier: NCT01430221
• Recruitment Status: Completed
• First Posted: September 8, 2011
• Last Update Posted: February 24, 2017
• Sponsor: Duke University
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Duke University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Prediabetes; Depressive Symptoms Mild to Moderate in Severity	Behavioral: Mindfulness-based Personalized Health Planning; Other: Structured & Guided Education	Not Applicable

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 Design

• 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

Arms and Interventions

Arm	Intervention/treatment
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 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..	Other: Structured & Guided Education; Other Name: SAGE

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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)

Secondary Outcome Measures :

1. 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.
2. 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..

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, North Carolina

Duke University Medical Center

Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Duke University

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Edward Suarez, Ph.D.; Duke University

More Information

Additional Information:

NIH Reporter website 

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT01430221 History of Changes
• Other Study ID Numbers: Pro00016540; R01HL067459 ( U.S. NIH Grant/Contract )
• First Posted: September 8, 2011
• Last Update Posted: February 24, 2017
• Last Verified: February 2017

Keywords provided by Duke University:

prediabetes; severity of depressive symptoms; mindfulness; personalized health planning; cardiometabolic diseases prevention

Additional relevant MeSH terms:

Heart Diseases; Prediabetic State; Glucose Intolerance; Depression; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Behavioral Symptoms