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

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.

There is a need for 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), a condition in which the fasting blood sugar level is 100 to 125 milligrams per deciliter (mg/dL), and psychological distress as indexed by greater severity of depressive symptoms, anger, and anger-related emotions, because they are at increased risk for developing disease. With few exceptions, current interventions are 'one-size fits all' and pay little or no attention to patients' individual goals, resources, and barriers in making positive behavior changes. This novel study adopts a 'patient-centered' strategy for decreasing risk for T2D and CHD and specifically a mindfulness-based personalized health planning (MB-PHP) as the primary intervention. MB-PHP incorporates four primary strategies: (1) individual risk quantification of T2D and cardiovascular disease (CVD) based on fasting blood sugar and a psychological risk profile; (2) group-based education on risk factors for CVD and T2D; (3) development of a personalized health plan (PHP); and (4) support in PHP implementation and patient engagement through integrative health partnering. To further support the goals of the PHP, mindfulness meditation will be used in the group setting to promote greater awareness of the unity of mind and body and specifically how unconscious thoughts, feelings, and behaviors can undermine emotional and physical health. The MB-PHP will stress personalized, predictive, and preventive risk management while fostering meaningful subject engagement with the goal of reducing risk factors for T2D and CVD.

• Behavioral: Lifestyle Intervention
  mindfulness-based personalized health planning with health coaching
• Behavioral: Structured and Guided Education
  structure and guided education with active listening

• Experimental: Mindfulness-based Personalized Health Planning (MB-PHP)
  Behavioral- 110 Subjects will participate in a 22-week Mindfulness-based Personalized Health Planning (MBPHP)with health coaching. MB-PHP intervention includes weekly small group meetings and bi-weekly telephonic health coaching.
  Intervention: Behavioral: Lifestyle Intervention
• Active Comparator: Structured and Guided Education
  110 subjects will participate in the Structure and guided education (SAGE). SAGE includes small group-education sessions once per week for 22 weeks. Subjects in this arm will also participate in biweekly telephone calls with health partners who will use supportive listening techniques, but will not provide "health coaching".
  Intervention: Behavioral: Structured and Guided Education

Inclusion Criteria:

1. Between 30 and 65 years old
2. Nonsmoker
3. Generally in good health
4. Able to speak and read English
5. Willing to provide informed consent
6. Scores greater than 29 for males and 28 for females on the psychological risk factor scale
7. Patient Health Questionnaire-9 scores greater than 5 (minimal depression) but less than 25 (severe depression)
8. HB A1c with eAG of 5.5%-6.4%
9. Able to attend 2 study visits at Duke University Medical Center
10. Able to attend 22 small group education sessions
11. Able to attend 10 telephonic support sessions

Exclusion Criteria:

1. Younger than 30years old/Older than 65
2. PHQ-9 score of 25 or greater (severe depression)
3. PRF scores less than 33 for females and 35 for males
4. BMI less than 19.1
5. Insulin resistance values less than 1.96 units or fasting glucose less than or equal to 100 mg/dl
6. History of cardiovascular disease (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., Cushings 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