Faith-based Approaches in the Treatment of Hypertension (FAITH)

Not Applicable

Completed

• Conditions: Hypertension

• Registration Number: NCT01065831
• Lead Sponsor: NYU Langone Health

Brief Summary

The purpose of this study is to test the effect of a church-based lifestyle intervention on blood pressure reduction in 400 hypertensive blacks (BP\> 140/90 mm hg).

Detailed Description

This study will test the effectiveness of a church-based lifestyle intervention in improving blood pressure control among 400 hypertensive blacks in a group randomized controlled trial. The lifestyle intervention will be delivered by trained lay health advisers through group-based behavioral counseling and motivational interviewing (MINT-TLC) in 24 predominantly black churches in New York City.

Study Timeline

• Study First Submitted: 2010-02-08
• Study First Submitted QC: 2010-02-08
• Study First Posted: 2010-02-09
• Study Start: 2010-11
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-29
• Last Update Posted: 2016-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 373

Inclusion Criteria

• Age 18 years or older
• Diagnosis of hypertension
• Self-identified Black or African American
• SBP > 140 mmHg or DBP > 90 mmHg (based on the average of 3 blood pressure readings); or average SBP > 130 mm Hg or DBP > 80 mm hg (for those with diabetes or kidney disease) at the screening/baseline visits
• Able to speak English

Exclusion Criteria

• Unable to comply with the study protocol (either self-selected or by indicating during screening that s/he could not complete all requested tasks).
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Within-individual change in systolic blood pressure and diastolic blood pressure	6 months

Secondary Outcome Measures

Name	Time	Method
Levels of physical activity	6 months
Percent change in weight	6 months
Dietary intake of fruits and vegetables	6 months
Proportion of blood pressure control	9 months

Trial Locations

Locations (1)

NYU School of Medicine; 🇺🇸 New York, New York, United States