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.
Mild to Moderately High Severity of Depressive Symptoms
Behavioral: Mindfulness-based Personalized Health Planning
Other: Structured & Guided Education
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Mindfulness-based Personalized Health Planning for Reducing Risk Factors of Heart Disease and Diabetes|
- Fasting glucose [ Time Frame: screening, post-intervention (6 months) ] [ Designated as safety issue: No ]Changes from entry levels of fasting glucose to 6-months levels.
- Severity of depressive symptoms [ Time Frame: baseline, post intervention (6 months) ] [ Designated as safety issue: No ]Pre-to-post intervention changes in severity of depressive symptoms as assessed via the Hamilton Depression (HAM-D) interview and the Beck Depression Inventory (BDI).
- Reduction in resting blood pressure [ Time Frame: Baseline, post-intervention (6 months) ] [ Designated as safety issue: No ]Pre-to-post intervention changes in systolic and diastolic blood pressure.
- Changes in inflammation [ Time Frame: baseline, post-intervention (6-months) ] [ Designated as safety issue: No ]Pre-to-post changes in inflammation as assessed by high sensitivity C-reactive protein (hsCRP).
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||May 2017|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: Mindfulness-based Personalized Health Planning
Mindfulness-based Personalized Health Planning (MB-PHP) includes 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|
Active Comparator: Structured & Guided Education
Structure & Guided Education (SAGE). SAGE includes small group-education sessions once per week for 22 weeks. Subjects participate in 10 bi-weekly telephone calls with education partners who use supportive listening techniques.
|Other: Structured & Guided Education|
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. It has been shown that 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. It has been shown that 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 A1c of 5.7%-6.4% or fasting glucose above 100 mg/dl and below 126 mg/dland) and elevated symptoms of depression. The MB-PHP incorporates four primary strategies: (1) individual risk quantification of T2D and cardiovascular disease (CVD) based on fasting blood sugar 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01430221
|Contact: Edward C Suarez, Ph.D.||email@example.com|
|Contact: Anne Dennos, M.S.||firstname.lastname@example.org|
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Anne Dennos, MPH 919-668-6420 email@example.com|
|Principal Investigator: Edward Suarez, Ph.D.|
|Principal Investigator:||Edward Suarez, Ph.D.||Duke University|