Counseling Older Adults to Control Hypertension (COACH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01180673|
Recruitment Status : Completed
First Posted : August 12, 2010
Last Update Posted : November 13, 2013
|Condition or disease||Intervention/treatment||Phase|
|Hypertension Vascular Diseases Cardiovascular Diseases||Behavioral: MINT-TLC Behavioral: Control Condition||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||251 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Counseling Older Adults to Control Hypertension|
|Study Start Date :||February 2008|
|Primary Completion Date :||December 2012|
|Study Completion Date :||December 2012|
This intervention is based on established clinical practice guidelines for prevention and treatment of hypertension, which recommend weight loss (if overweight), limiting sodium and alcohol intake, regular physical activity, and eating a low-fat diet that is rich in fruit and vegetables. Seniors will attend weekly group classes conducted by trained research assistants for the first 12 weeks (intensive phase); followed by three individual motivational interview (MINT) sessions that will occur monthly over the next three months (extended phase); and finally each senior will receive three bi-monthly booster MINT sessions in the remaining six months (maintenance phase).
|Active Comparator: Control Condition||
Behavioral: Control Condition
Seniors randomized to the control arm will receive a single individual brief advice session on therapeutic lifestyle changes recommended for blood pressure reduction. In addition, they will be given print versions of the NHLBI publications "Your Guide to Lowering Blood Pressure"; and "Facts about the DASH Eating Plan." Sessions will be delivered by trained research assistants.
- Within-individual change in systolic blood pressure and diastolic blood pressure from baseline to 12 months [ Time Frame: 12 months ]
- Change in physical activity level from baseline to 12 months [ Time Frame: 12 months ]Physical activity is assessed using the Yale Physical Activity Scale (YPAS) and the International Physical Activity Questionnaire (IPAQ). Data collected with the YPAS will be reported as a final total activity dimension score. Data collected for the IPAQ will be expressed in MET-min per day or categorically (low, moderate, high).
- Percent change in weight from baseline to 12 months [ Time Frame: 12 months ]
- Change in number of daily servings of fruits and vegetables from baseline to 12 months [ Time Frame: 12 months ]
- Proportion of participants with adequate blood pressure control at 12 months [ Time Frame: 12 months ]
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): NCT01180673
|United States, New York|
|Senior Centers affiliated with NYC Department for the Aging|
|New York, New York, United States, 10010|
|Principal Investigator:||Olugbenga Ogedegbe, MD, MS, MPH, FACP||New York University School of Medicine|