Counseling Older Adults to Control Hypertension

Study Overview
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Brief Summary
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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.

Official Title
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Counseling Older Adults to Control Hypertension

Conditions
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Hypertension, Vascular Diseases, Cardiovascular Diseases

Intervention / Treatment
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* Behavioral: MINT-TLC
* Behavioral: Control Condition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 60 years or older Diagnosis of HTN Taking at least one anti-hypertensive medication Self-identified Black, African American, or Latino Exclusion Criteria: Unable to comply with the study protocol Participation in other hypertension studies Severe hearing impairment Severe visual impairment Arm circumference > 42 cm for large cuff, or arm circumference > 52 cm for extra large cuff (if extra large cuff is available)

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MINT-TLC<br> | Behavioral: MINT-TLC<br>* 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).<br>|
| Active Comparator: Control Condition<br> | Behavioral: Control Condition<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Within-individual change in systolic blood pressure and diastolic blood pressure from baseline to 12 months |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical activity level from baseline to 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). | 12 months | 
| Percent change in weight from baseline to 12 months |  | 12 months | 
| Change in number of daily servings of fruits and vegetables from baseline to 12 months |  | 12 months | 
| Proportion of participants with adequate blood pressure control at 12 months |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Older Adults, Motivational Interviewing, Lifestyle Counseling, Senior Centers