NCT01180673

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
251

participants targeted

Target at P25-P50 for phase_3 hypertension

Timeline
Completed

Started Feb 2008

Longer than P75 for phase_3 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2010

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 12, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 27, 2019

Status Verified

March 1, 2019

Enrollment Period

4.8 years

First QC Date

July 27, 2010

Last Update Submit

March 25, 2019

Conditions

HypertensionVascular DiseasesCardiovascular Diseases

Keywords

HypertensionOlder AdultsMotivational InterviewingLifestyle CounselingSenior Centers

Outcome Measures

Primary Outcomes (1)

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

    12 months

Secondary Outcomes (4)

  • Change in physical activity level from baseline to 12 months

    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

Study Arms (2)

MINT-TLC

EXPERIMENTAL
Behavioral: MINT-TLC

Control Condition

ACTIVE COMPARATOR
Behavioral: Control Condition

Interventions

MINT-TLCBEHAVIORAL

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).

MINT-TLC
Control ConditionBEHAVIORAL

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.

Control Condition

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 60 years or older
  • Diagnosis of HTN
  • Taking at least one anti-hypertensive medication
  • Self-identified Black, African American, or Latino

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Senior Centers affiliated with NYC Department for the Aging

New York, New York, 10010, United States

Location

Related Publications (1)

  • 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.

    PMID: 23462343DERIVED

MeSH Terms

Conditions

HypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Olugbenga Ogedegbe, MD, MS, MPH, FACP

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2010

First Posted

August 12, 2010

Study Start

February 1, 2008

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

March 27, 2019

Record last verified: 2019-03

Locations

US(1)