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

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Behavioral: Motivational interviewing (MINT-TLC)

• 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

Arm && Interventions

Group	Intervention	Description
Health Education Control Condition	Motivational interviewing (MINT-TLC)	Participants randomized to this control condition will receive traditional, group health education classes for 12 weeks delivered by experts on various health topics unrelated to hypertension such as cancer, health insurance, and depression.
Lifestyle counseling	Motivational interviewing (MINT-TLC)	This MINT-TLC group will be asked to attend 12 weekly counseling meetings focused on weight loss (if overweight), limiting sodium, regular physical activity, and eating a low-fat diet that is rich in fruit and vegetables. MINT-TLC will be conducted by trained Lay Health Advisors. Participants will attend weekly group classes targeted at lifestyle changes for the first 12 weeks (intensive phase); followed by three individual MINT sessions conducted monthly for the following three months (maintenance phase). The MINT-TLC sessions aim to help participants make useful therapeutic lifestyle changes (TLC) and develop skills to maintain these changes long-term.

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