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Counseling Older Adults to Control Hypertension (COACH)

Primary Purpose

Hypertension, Vascular Diseases, Cardiovascular Diseases

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
MINT-TLC
Control Condition
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Older Adults, Motivational Interviewing, Lifestyle Counseling, Senior Centers

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Senior Centers affiliated with NYC Department for the Aging

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MINT-TLC

Control Condition

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).
Percent change in weight from baseline to 12 months
Change in number of daily servings of fruits and vegetables from baseline to 12 months
Proportion of participants with adequate blood pressure control at 12 months

Full Information

First Posted
July 27, 2010
Last Updated
March 25, 2019
Sponsor
NYU Langone Health
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD), Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT01180673
Brief Title
Counseling Older Adults to Control Hypertension
Acronym
COACH
Official Title
Counseling Older Adults to Control Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD), Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Vascular Diseases, Cardiovascular Diseases
Keywords
Hypertension, Older Adults, Motivational Interviewing, Lifestyle Counseling, Senior Centers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
251 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MINT-TLC
Arm Type
Experimental
Arm Title
Control Condition
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
MINT-TLC
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Control Condition
Intervention Description
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 Measure Information:
Title
Within-individual change in systolic blood pressure and diastolic blood pressure from baseline to 12 months
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in physical activity level from baseline to 12 months
Description
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).
Time Frame
12 months
Title
Percent change in weight from baseline to 12 months
Time Frame
12 months
Title
Change in number of daily servings of fruits and vegetables from baseline to 12 months
Time Frame
12 months
Title
Proportion of participants with adequate blood pressure control at 12 months
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olugbenga Ogedegbe, MD, MS, MPH, FACP
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Senior Centers affiliated with NYC Department for the Aging
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23462343
Citation
Ogedegbe G, Fernandez S, Fournier L, Silver SA, Kong J, Gallagher S, de la Calle F, Plumhoff J, Sethi S, Choudhury E, Teresi JA. The Counseling Older Adults to Control Hypertension (COACH) trial: design and methodology of a group-based lifestyle intervention for hypertensive minority older adults. Contemp Clin Trials. 2013 May;35(1):70-9. doi: 10.1016/j.cct.2013.02.008. Epub 2013 Feb 24.
Results Reference
derived

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Counseling Older Adults to Control Hypertension

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