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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Duke University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01430221
First received: September 2, 2011
Last updated: October 3, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Prediabetes
Mild to Moderately High Severity of Depressive Symptoms
Behavioral: Mindfulness-based Personalized Health Planning
Other: Structured & Guided Education
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 220
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)
Arms Assigned Interventions
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

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. 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.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
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) or fasting insulin between 100-125 mg/dl (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 attend 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)

4. Hemoglobin A1c below 5.6% and 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01430221

Contacts
Contact: Edward C Suarez, Ph.D. 919-684-2941 edward.suarez@duke.edu
Contact: Anne Dennos, M.S. 919-668-6420 anne.dennos@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Anne Dennos, MPH    919-668-6420    anne.dennos@duke.edu   
Principal Investigator: Edward Suarez, Ph.D.         
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Edward Suarez, Ph.D. Duke University
  More Information

Additional Information:
No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01430221     History of Changes
Other Study ID Numbers: Pro00016540, R01HL067459-06A2
Study First Received: September 2, 2011
Last Updated: October 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
prediabetes
severity of depressive symptoms
mindfulness
personalized health planning
cardiometabolic diseases prevention

Additional relevant MeSH terms:
Glucose Intolerance
Heart Diseases
Prediabetic State
Cardiovascular Diseases
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Hyperglycemia
Metabolic Diseases

ClinicalTrials.gov processed this record on November 20, 2014