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OpenTrials
Completed

NCT Number: NCT01180673

Counseling Older Adults to Control Hypertension

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Senior Centers affiliated with NYC Department for the Aging

New York, 10010, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MINT-TLC

Behavioral

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).

Control condition

Behavioral

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 outcomes

  1. Within-individual change in systolic blood pressure and diastolic blood pressure from baseline to 12 months

    Time frame: 12 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Columbia University
  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Acronym: COACH

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Aug 12, 2010
Registry last updated
Mar 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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