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

This study is currently recruiting participants.
Verified January 2013 by Duke University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01430221
First received: September 2, 2011
Last updated: January 24, 2013
Last verified: January 2013
  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
Behavioral: Lifestyle Intervention
Behavioral: Structured and 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:
  • Insulin Resistance [ Time Frame: screening, post-intervention (6 months) ] [ Designated as safety issue: No ]
    Changes from baseline insulin resistance at 6-months. Insulin resistance will be assessed using the homeostasis model of assessment for insulin resistance. This model uses fasting levels of insulin and glucose to determine insulin resistance.


Secondary Outcome Measures:
  • Stress responses [ Time Frame: Baseline, post-intervention (6 months) ] [ Designated as safety issue: No ]
    Changes in baseline stress responses to an anger induction procedure at 6-months. Measures of stress responses include measures of heart rate, blood pressure, stress hormones, metabolism, inflammation, emotions, and mindful qualities.


Estimated Enrollment: 220
Study Start Date: May 2011
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Lifestyle Intervention
mindfulness-based personalized health planning with health coaching
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".
Behavioral: Structured and Guided Education
structure and guided education with active listening

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

Contacts
Contact: Edward Suarez, Ph.D. 919-684-2941 edward.suarez@duke.edu
Contact: Anne Dennos, B.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: Sarah Rowe, B.S.     919-668-6420     sarah.rowe@duke.edu    
Principal Investigator: Edward Suarez, Ph.D.            
Sub-Investigator: Jeffrey Greeson, Ph.D.            
Sub-Investigator: Leigh Ann Simmons, 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: January 24, 2013
Health Authority: United States: Institutional Review Board
Unites States: Federal Governmnent

Keywords provided by Duke University:
diabetes
prediabetes
mindfulness
heart disease prevention
diabetes prevention

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

ClinicalTrials.gov processed this record on June 18, 2013