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

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.

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