Counseling Older Adults to Control Hypertension (COACH)
This study will evaluate the effect of a senior center-based comprehensive therapeutic lifestyle intervention delivered through group-based counseling and motivational interviewing (MINT-TLC) among 250 hypertensive African American or Latino seniors age 60 and older in a randomized control trial.
Behavioral: Control Condition
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Counseling Older Adults to Control Hypertension|
- Within-individual change in systolic blood pressure and diastolic blood pressure from baseline to 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Change in physical activity level from baseline to 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Change in number of daily servings of fruits and vegetables from baseline to 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Proportion of participants with adequate blood pressure control at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2008|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|