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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 : March 27, 2019
Sponsor:
Collaborators:
National Institute on Minority Health and Health Disparities (NIMHD)
Columbia University
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Vascular Diseases Cardiovascular Diseases Behavioral: MINT-TLC Behavioral: Control Condition Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 251 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Counseling Older Adults to Control Hypertension
Study Start Date : February 2008
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MINT-TLC Behavioral: MINT-TLC
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.




Primary Outcome Measures :
  1. Within-individual change in systolic blood pressure and diastolic blood pressure from baseline to 12 months [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. 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).

  2. Percent change in weight from baseline to 12 months [ Time Frame: 12 months ]
  3. Change in number of daily servings of fruits and vegetables from baseline to 12 months [ Time Frame: 12 months ]
  4. Proportion of participants with adequate blood pressure control at 12 months [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

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


Locations
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United States, New York
Senior Centers affiliated with NYC Department for the Aging
New York, New York, United States, 10010
Sponsors and Collaborators
NYU Langone Health
National Institute on Minority Health and Health Disparities (NIMHD)
Columbia University
Investigators
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Principal Investigator: Olugbenga Ogedegbe, MD, MS, MPH, FACP NYU Langone Health
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT01180673    
Other Study ID Numbers: 08-416
P60MD000206 ( U.S. NIH Grant/Contract )
First Posted: August 12, 2010    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NYU Langone Health:
Hypertension
Older Adults
Motivational Interviewing
Lifestyle Counseling
Senior Centers
Additional relevant MeSH terms:
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Hypertension
Cardiovascular Diseases
Vascular Diseases