Counseling Older Adults to Control Hypertension (COACH)

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Intervention / Treatment: Behavioral: MINT-TLC; Behavioral: Control Condition

• Study Type: Interventional
• Enrollment (Actual): 251
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10010
      • Senior Centers affiliated with NYC Department for the Aging

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Within-individual change in systolic blood pressure and diastolic blood pressure from baseline to 12 months	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: Columbia University; National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Olugbenga Ogedegbe, MD, MS, MPH, FACP, NYU Langone Health

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: July 27, 2010
• First Submitted That Met QC Criteria: August 10, 2010
• First Posted (Estimate): August 12, 2010

Study Record Updates

• Last Update Posted (Actual): March 27, 2019
• Last Update Submitted That Met QC Criteria: March 25, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Motivational Interviewing; Hypertension; Older Adults; Lifestyle Counseling; Senior Centers
• Additional Relevant MeSH Terms: Hypertension; Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: 08-416; P60MD000206 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No