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Counseling Older Adults to Control Hypertension (COACH)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Center on Minority Health and Health Disparities (NCMHD)
Columbia University
Information provided by:
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01180673
First received: July 27, 2010
Last updated: October 16, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention Phase
Hypertension
Vascular Diseases
Cardiovascular Diseases
 Behavioral: MINT-TLC
Behavioral: Control Condition
 Phase 3

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 250
Study Start Date: February 2008
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 Center on Minority Health and Health Disparities (NCMHD)
Columbia University
Investigators
Principal Investigator: Olugbenga Ogedegbe, MD, MS, MPH, FACP New York University School of Medicine
  More Information

No publications provided

Responsible Party: Olugbenga Ogedegbe, MD, MS, MPH, FACP, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01180673     History of Changes
Other Study ID Numbers: P60MD000206, P60MD000206
Study First Received: July 27, 2010
Last Updated: October 16, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypertension
Vascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013