Mindfulness-based Personalized Health Planning for Reducing Risk of Heart Disease and Diabetes
Condition: Prediabetes; Depressive Symptoms Mild to Moderate in Severity
MeSH terms: Heart Diseases; Prediabetic State; Glucose Intolerance; Depression
Study type: Interventional

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.
    

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.
    

Intervention name(s): Mindfulness-based Personalized Health Planning; Structured & Guided Education
Intervention type(s): Behavioral; Other
Other intervention name(s): MB-PHP; SAGE
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: prediabetes; severity of depressive symptoms; mindfulness; personalized health planning; cardiometabolic diseases prevention