PrediabetesAWARENESSNCT01430221
Mindfulness-based Personalized Health Planning for Reducing Risk of Heart Disease and Diabetes
A study testing Mindfulness-based Personalized Health Planning and Structured & Guided Education in people with Prediabetes and Depressive Symptoms Mild to Moderate in Severity, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Prediabetes, Depressive Symptoms Mild to Moderate in Severity
- What is being tested?
- Mindfulness-based Personalized Health Planning and Structured & Guided Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to 15 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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.
Read the 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.
- Being tested
- Mindfulness-based Personalized Health Planning, Structured & Guided Education
- Keywords
- prediabetes, severity of depressive symptoms, mindfulness, personalized health planning, cardiometabolic diseases prevention
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based Personalized Health PlanningBehavioural
Also called MB-PHP
Structured & Guided EducationOther
Also called SAGE
| Study group | Role | What they receive |
|---|---|---|
| MB-PHP Group | Experimental | 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. Receives: Behavioral: Mindfulness-based Personalized Health Planning |
| SAGE Group | Active comparator | 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.. Receives: Other: Structured & Guided Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting glucose
Changes from entry levels of fasting glucose up to 45-days post-intervention, and long-term follow-up (>6-months) levels.
Measured: screening, up to 45-days after completion of intervention, long term follow-up (>6 months)
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)
Measured: baseline, up to 45-days after completion of intervention, long-term follow-up (>6 months)
Secondary outcomes (2)
Reduction in resting blood pressure
Changes in systolic and diastolic blood pressure 45-days following completion of intervention and long-term follow-up.
Measured: Baseline, up to 45-days after completion of intervention, long-term follow-up (>6 months)
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..
Measured: baseline, 45-days following completion of intervention and long-term follow-up(>6-months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2011 (estimated)
- Study startMay 2011
- Primary completion15 Feb 2017
- Study completion15 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Edward Suarez, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01430221
- Sponsor's protocol ID
- Pro00016540
- Other IDs
- R01HL067459
- Acronym
- AWARENESS
- Status last verified
- Feb 2017
- First submitted
- 2 Sep 2011
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-based Personalized Health Planning for Reducing Risk of Heart Disease and Diabetes
- ClinicalTrials.gov ID
- NCT01430221
- Acronym / sponsor ID
- AWARENESS / Pro00016540
- Keywords
- prediabetes, severity of depressive symptoms, mindfulness, personalized health planning, cardiometabolic diseases prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- May 2011
- Primary completion
- 15 Feb 2017 (actual)
- Study completion
- 15 Feb 2017 (actual)
- First posted
- 8 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MB-PHP Group | Experimental | Behavioral: Mindfulness-based Personalized Health PlanningMindfulness-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. |
| SAGE Group | Active comparator | Other: Structured & Guided EducationStructure \& 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.. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based Personalized Health PlanningAlso: MB-PHP | Behavioural | MB-PHP Group |
| Structured & Guided EducationAlso: SAGE | Other | SAGE Group |
Primary outcome
Fasting glucose
Time frame: screening, up to 45-days after completion of intervention, long term follow-up (>6 months)
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
Time frame: baseline, up to 45-days after completion of intervention, long-term follow-up (>6 months)
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)
2 secondary outcomes
Reduction in resting blood pressure
Time frame: Baseline, up to 45-days after completion of intervention, long-term follow-up (>6 months)
Changes in inflammation
Time frame: baseline, 45-days following completion of intervention and long-term follow-up(>6-months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Suarez, Ph.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based Personalized Health Planning and Structured & Guided Education in people with Prediabetes and Depressive Symptoms Mild to Moderate in Severity, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting glucose (time frame: screening, up to 45-days after completion of intervention, long term follow-up (>6 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2017; AzTrials last refreshed its copy on 26 Oct 2026.