Back to results

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

Primary Purpose

Prediabetes, Depressive Symptoms Mild to Moderate in Severity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Mindfulness-based Personalized Health Planning

Structured & Guided Education

About this trial

This is an interventional prevention trial for Prediabetes focused on measuring prediabetes, severity of depressive symptoms, mindfulness, personalized health planning, cardiometabolic diseases prevention

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

Younger than 30 years old/Older than 70
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

Sites / Locations

Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MB-PHP Group

SAGE Group

Arm Description

Mindfulness-based Personalized Health Planning (MB-PHP)with health coaching. MB-PHP includes weekly small group meetings for 22-weeks and 10 bi-weekly telephonic health coaching.

Structure & Guided Education (SAGE) includes small group-education sessions once per week for 22 weeks. Subjects also participate in 10 bi-weekly telephone calls with education partners who use supportive listening techniques..

Outcomes

Primary Outcome Measures

Fasting glucose

Changes from entry levels of fasting glucose up to 45-days post-intervention, and long-term follow-up (>6-months) levels.

Severity of depressive symptoms

Changes from entry levels of severity of depressive symptoms as assessed via the Hamilton Depression (HAM-D) interview to 45-days after completion of intervention and long-term follow-up (> 6-months)

Secondary Outcome Measures

Reduction in resting blood pressure

Changes in systolic and diastolic blood pressure 45-days following completion of intervention and long-term follow-up.

Changes in inflammation

Pre-to-post changes in inflammation as assessed by high sensitivity C-reactive protein (hsCRP) and in vitro production of stimulated cytokines 45-days following completion of intervention and long-term follow-up..

Full Information

NCT ID

NCT01430221

First Posted

September 2, 2011

Last Updated

February 23, 2017

Sponsor

Duke University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT01430221

Brief Title

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

Acronym

AWARENESS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

February 15, 2017 (Actual)

Study Completion Date

February 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prediabetes, Depressive Symptoms Mild to Moderate in Severity

Keywords

prediabetes, severity of depressive symptoms, mindfulness, personalized health planning, cardiometabolic diseases prevention

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MB-PHP Group

Arm Type

Experimental

Arm Description

Mindfulness-based Personalized Health Planning (MB-PHP)with health coaching. MB-PHP includes weekly small group meetings for 22-weeks and 10 bi-weekly telephonic health coaching.

Arm Title

SAGE Group

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Mindfulness-based Personalized Health Planning

Other Intervention Name(s)

MB-PHP

Intervention Type

Other

Intervention Name(s)

Structured & Guided Education

Other Intervention Name(s)

SAGE

Primary Outcome Measure Information:

Title

Fasting glucose

Description

Changes from entry levels of fasting glucose up to 45-days post-intervention, and long-term follow-up (>6-months) levels.

Time Frame

screening, up to 45-days after completion of intervention, long term follow-up (>6 months)

Title

Severity of depressive symptoms

Description

Changes from entry levels of severity of depressive symptoms as assessed via the Hamilton Depression (HAM-D) interview to 45-days after completion of intervention and long-term follow-up (> 6-months)

Time Frame

baseline, up to 45-days after completion of intervention, long-term follow-up (>6 months)

Secondary Outcome Measure Information:

Title

Reduction in resting blood pressure

Description

Changes in systolic and diastolic blood pressure 45-days following completion of intervention and long-term follow-up.

Time Frame

Baseline, up to 45-days after completion of intervention, long-term follow-up (>6 months)

Title

Changes in inflammation

Description

Time Frame

baseline, 45-days following completion of intervention and long-term follow-up(>6-months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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) 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: Younger than 30 years old/Older than 70 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Edward Suarez, Ph.D.

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Links:

URL

http://projectreporter.nih.gov/project_info_description.cfm?aid=7922033&icde=0

Description

NIH Reporter website

Learn more about this trial

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

We'll reach out to this number within 24 hrs