Counseling Older Adults to Control Hypertension

NCT ID: NCT01180673

Last Updated: 2019-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

251 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension Vascular Diseases Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MINT-TLC

Group Type EXPERIMENTAL

MINT-TLC

Intervention Type 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

Group Type ACTIVE_COMPARATOR

Control Condition

Intervention Type 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.

Interventions

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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).

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olugbenga Ogedegbe, MD, MS, MPH, FACP

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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Senior Centers affiliated with NYC Department for the Aging

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 23462343 (View on PubMed)

Other Identifiers

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P60MD000206

Identifier Type: NIH

Identifier Source: secondary_id

View Link

08-416

Identifier Type: -

Identifier Source: org_study_id

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