Counseling Older Adults to Control Hypertension

Phase 3

Completed

• Conditions: Vascular Diseases; Hypertension; Cardiovascular Diseases
• Interventions: Behavioral: MINT-TLC; Behavioral: Control Condition

• Registration Number: NCT01180673
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2010-07-27
• Study First Submitted QC: 2010-08-10
• Study First Posted: 2010-08-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-25
• Last Update Posted: 2019-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 251

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MINT-TLC	MINT-TLC	-
Control Condition	Control Condition	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in physical activity level from baseline to 12 months	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).
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
Percent change in weight from baseline to 12 months	12 months

Trial Locations

Locations (1)

Senior Centers affiliated with NYC Department for the Aging; 🇺🇸 New York, New York, United States