Clinical trial NCT01065831: Faith-based Approaches in the Treatment of Hypertension (FAITH)
Official title: Faith-based Approaches in the Treatment of Hypertension (FAITH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: motivational interviewing, lay health advisers
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2010-02-09
Enrollment: 373
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Within-individual change in systolic blood pressure and diastolic blood pressure
timeFrame: 6 months
Secondary outcomes:
measure: Levels of physical activity
timeFrame: 6 months
measure: Percent change in weight
timeFrame: 6 months
measure: Dietary intake of fruits and vegetables
timeFrame: 6 months
measure: Proportion of blood pressure control
timeFrame: 9 months
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU School of Medicine
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Gbenga Ogedegbe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU Steinhardt School
name: Kristie Lancaster, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU School of Medicine
name: Antoinette Schoenthaler, EdD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.