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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01065831
First Posted: February 9, 2010
Last Update Posted: March 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Gbenga Ogedegbe, New York University School of Medicine
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Faith-based Approaches in the Treatment of Hypertension (FAITH)

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

Primary Outcome Measures:
  • Within-individual change in systolic blood pressure and diastolic blood pressure [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Levels of physical activity [ Time Frame: 6 months ]
  • Percent change in weight [ Time Frame: 6 months ]
  • Dietary intake of fruits and vegetables [ Time Frame: 6 months ]
  • Proportion of blood pressure control [ Time Frame: 9 months ]

Enrollment: 373
Study Start Date: November 2010
Study Completion Date: June 2014
Primary Completion Date: June 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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01065831


Locations
United States, New York
NYU School of Medicine
New York, New York, United States, 10010
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 ( U.S. NIH Grant/Contract )
First Submitted: February 8, 2010
First Posted: February 9, 2010
Last Update Posted: March 1, 2016
Last Verified: February 2016

Keywords provided by Gbenga Ogedegbe, New York University School of Medicine:
motivational interviewing, lay health advisers

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases