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