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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

February 8, 2010
August 13, 2013
November 2010
July 2014   (final data collection date for primary outcome measure)
Within-individual change in systolic blood pressure and diastolic blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01065831 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Faith-based Approaches in the Treatment of Hypertension (FAITH)
Faith-based Approaches in the Treatment of Hypertension (FAITH)

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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
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
  • 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.
    Intervention: Behavioral: Motivational interviewing (MINT-TLC)
  • 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.
    Intervention: Behavioral: Motivational interviewing (MINT-TLC)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
400
July 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01065831
FAITH 09-0558, 1R01HL092860-01A1
Yes
Gbenga Ogedegbe, New York University School of Medicine
New York University School of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
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
New York University School of Medicine
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP