Counseling Older Adults to Control Hypertension (COACH)

This study has been completed.
Sponsor:
Collaborators:
Columbia University
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01180673
First received: July 27, 2010
Last updated: November 12, 2013
Last verified: November 2013

July 27, 2010
November 12, 2013
February 2008
December 2012   (final data collection date for primary outcome measure)
Within-individual change in systolic blood pressure and diastolic blood pressure from baseline to 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01180673 on ClinicalTrials.gov Archive Site
  • Change in physical activity level from baseline to 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in number of daily servings of fruits and vegetables from baseline to 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Proportion of participants with adequate blood pressure control at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Counseling Older Adults to Control Hypertension
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hypertension
  • Vascular Diseases
  • Cardiovascular Diseases
  • 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).
  • 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
    Intervention: Behavioral: MINT-TLC
  • Active Comparator: Control Condition
    Intervention: Behavioral: Control Condition
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
251
December 2012
December 2012   (final data collection date for primary outcome measure)

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)
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01180673
P60MD000206, P60MD000206
Yes
New York University School of Medicine
New York University School of Medicine
  • National Center on Minority Health and Health Disparities (NCMHD)
  • Columbia University
Principal Investigator: Olugbenga Ogedegbe, MD, MS, MPH, FACP New York University School of Medicine
New York University School of Medicine
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP