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

NCT ID: NCT01065831

Last Updated: 2016-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 373 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2014-06-30

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lifestyle counseling

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.

Group Type: EXPERIMENTAL

Motivational interviewing (MINT-TLC)

Intervention Type: BEHAVIORAL

The MINT-TLC lifestyle intervention lead by lay health advisers will be compared to the health education attention control condition (CC). Twenty churches will participate in the study and each church will be randomly assigned to receive either MINT-TLC or CC. They will be compared on blood pressure reduction, physical activity levels, intake of fruits and vegetables, and weight reduction.

Health Education Control Condition

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.

Group Type: PLACEBO_COMPARATOR

Motivational interviewing (MINT-TLC)

Intervention Type: BEHAVIORAL

The MINT-TLC lifestyle intervention lead by lay health advisers will be compared to the health education attention control condition (CC). Twenty churches will participate in the study and each church will be randomly assigned to receive either MINT-TLC or CC. They will be compared on blood pressure reduction, physical activity levels, intake of fruits and vegetables, and weight reduction.

Interventions

Motivational interviewing (MINT-TLC)

The MINT-TLC lifestyle intervention lead by lay health advisers will be compared to the health education attention control condition (CC). Twenty churches will participate in the study and each church will be randomly assigned to receive either MINT-TLC or CC. They will be compared on blood pressure reduction, physical activity levels, intake of fruits and vegetables, and weight reduction.

Intervention Type: BEHAVIORAL

Other Intervention Names

Church-based lifestyle intervention; FAITH

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Gbenga Ogedegbe

Professor of Population Health and Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gbenga Ogedegbe, MD

Role: PRINCIPAL_INVESTIGATOR

NYU School of Medicine

Kristie Lancaster, PhD

Role: PRINCIPAL_INVESTIGATOR

NYU Steinhardt School

Antoinette Schoenthaler, EdD

Role: STUDY_DIRECTOR

NYU School of Medicine

Locations

NYU School of Medicine

New York, New York, United States

Countries

United States

References

Schoenthaler AM, Lancaster KJ, Chaplin W, Butler M, Forsyth J, Ogedegbe G. Cluster Randomized Clinical Trial of FAITH (Faith-Based Approaches in the Treatment of Hypertension) in Blacks. Circ Cardiovasc Qual Outcomes. 2018 Oct;11(10):e004691. doi: 10.1161/CIRCOUTCOMES.118.004691.

Reference Type: DERIVED

PMID: 30354579 (View on PubMed)

Lancaster KJ, Schoenthaler AM, Midberry SA, Watts SO, Nulty MR, Cole HV, Ige E, Chaplin W, Ogedegbe G. Rationale and design of Faith-based Approaches in the Treatment of Hypertension (FAITH), a lifestyle intervention targeting blood pressure control among black church members. Am Heart J. 2014 Mar;167(3):301-7. doi: 10.1016/j.ahj.2013.10.026. Epub 2013 Nov 6.

Reference Type: DERIVED

PMID: 24576512 (View on PubMed)

Other Identifiers

1R01HL092860-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

FAITH 09-0558

Identifier Type: -

Identifier Source: org_study_id