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

NYU Langone Health

Status: Completed

Conditions: Hypertension

Treatments: Behavioral: Motivational interviewing (MINT-TLC)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01065831

FAITH 09-0558

1R01HL092860-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 373 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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373 participants in 2 patient groups, including a placebo group

Lifestyle counseling

Experimental group

Description:

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.

Treatment:

Behavioral: Motivational interviewing (MINT-TLC)

Health Education Control Condition

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Motivational interviewing (MINT-TLC)