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Counseling Older Adults to Control Hypertension (COACH)

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ClinicalTrials.gov Identifier: NCT01180673
Recruitment Status : Completed
First Posted : August 12, 2010
Last Update Posted : November 13, 2013
Sponsor:
Collaborators:
National Institute on Minority Health and Health Disparities (NIMHD)
Columbia University
Information provided by (Responsible Party):
New York University School of Medicine

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

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

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 ]


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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
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
United States, New York
Senior Centers affiliated with NYC Department for the Aging
New York, New York, United States, 10010
Sponsors and Collaborators
New York University School of Medicine
National Institute on Minority Health and Health Disparities (NIMHD)
Columbia University
Investigators
Principal Investigator: Olugbenga Ogedegbe, MD, MS, MPH, FACP New York University School of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01180673     History of Changes
Other Study ID Numbers: P60MD000206 ( U.S. NIH Grant/Contract )
P60MD000206 ( U.S. NIH Grant/Contract )
First Posted: August 12, 2010    Key Record Dates
Last Update Posted: November 13, 2013
Last Verified: November 2013

Keywords provided by New York University School of Medicine:
Hypertension
Older Adults
Motivational Interviewing
Lifestyle Counseling
Senior Centers

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases