Mindfulness-based Personalized Health Planning for Reducing Risk of Heart Disease and Diabetes (AWARENESS)
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|ClinicalTrials.gov Identifier: NCT01430221|
Recruitment Status : Completed
First Posted : September 8, 2011
Last Update Posted : February 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Prediabetes Depressive Symptoms Mild to Moderate in Severity||Behavioral: Mindfulness-based Personalized Health Planning Other: Structured & Guided Education||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Mindfulness-based Personalized Health Planning for Reducing Risk of Heart Disease and Diabetes|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||February 15, 2017|
|Actual Study Completion Date :||February 15, 2017|
Experimental: MB-PHP Group
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.
Behavioral: Mindfulness-based Personalized Health Planning
Other Name: MB-PHP
Active Comparator: SAGE Group
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..
Other: Structured & Guided Education
Other Name: SAGE
- 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)
- Reduction in resting blood pressure [ Time Frame: Baseline, up to 45-days after completion of intervention, long-term follow-up (>6 months) ]Changes in systolic and diastolic blood pressure 45-days following completion of intervention and long-term follow-up.
- Changes in inflammation [ Time Frame: baseline, 45-days following completion of intervention and long-term follow-up(>6-months) ]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..
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01430221
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Edward Suarez, Ph.D.||Duke University|