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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gbenga Ogedegbe, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01065831
First received: February 8, 2010
Last updated: August 13, 2013
Last verified: August 2013
  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:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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 by New York University School of Medicine

Additional 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
Study First Received: February 8, 2010
Last Updated: August 13, 2013
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
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014