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

Purpose

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).

Condition	Intervention
Hypertension	Behavioral: Motivational interviewing (MINT-TLC)

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Faith-based Approaches in the Treatment of Hypertension (FAITH)

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

U.S. FDA Resources

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:

Within-individual change in systolic blood pressure and diastolic blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Levels of physical activity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Percent change in weight [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Dietary intake of fruits and vegetables [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Proportion of blood pressure control [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	November 2010
Estimated Study Completion Date:	July 2014
Estimated Primary Completion Date:	July 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Behavioral: 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. Other Names: Church-based lifestyle intervention FAITH
Placebo Comparator: 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.	Behavioral: 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. Other Names: Church-based lifestyle intervention FAITH

Arms

Assigned Interventions

Experimental: 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.

Behavioral: 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.

Other Names:

Church-based lifestyle intervention
FAITH

Placebo Comparator: 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.

Behavioral: 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.

Other Names:

Church-based lifestyle intervention
FAITH

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01065831

Contacts

Contact: Antoinette Schoenthaler, EdD	212-263-4205	Antoinette.schoenthaler@nyumc.org
Contact: Sara Midberry, MPH	212-263-4285	sara.midberry@nyumc.org

Locations

United States, New York
NYU School of Medicine	Recruiting
New York, New York, United States, 10010
Contact: Sara A Midberry, MPH 212-263-4285 sara.gallagher@nyumc.org

Sponsors and Collaborators

New York University School of Medicine

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:	Gbenga Ogedegbe, MD	NYU School of Medicine
Principal Investigator:	Kristie Lancaster, PhD	NYU Steinhardt School
Study Director:	Antoinette Schoenthaler, EdD	NYU School of Medicine

More Information

No publications provided

Responsible Party:	Gbenga Ogedegbe, Professor of Population Health and Medicine, New York University School of Medicine
ClinicalTrials.gov Identifier:	NCT01065831 History of Changes
Other Study ID Numbers:	FAITH 09-0558, 1R01HL092860-01A1
Study First Received:	February 8, 2010
Last Updated:	October 19, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by New York University School of Medicine:

motivational interviewing, lay health advisers

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013