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CompletedNCT01065831FAITHUpdated Mar 1, 2016

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

An interventional study of Motivational interviewing (MINT-TLC) in Hypertension, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-01.

Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
373
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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).

Read the 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.

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Conditions studied

  • Hypertension

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Keywords

  • motivational interviewing, lay health advisers
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In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 373 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
373 participants (actual)

Study arms

  • 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)

  • 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)

Interventions

  • BehavioralMotivational 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.

    Also known as: Church-based lifestyle intervention, FAITH

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What researchers measure

Primary outcomes

  1. Within-individual change in systolic blood pressure and diastolic blood pressure

    Time frame: 6 months

Secondary outcomes

  1. Levels of physical activity

    Time frame: 6 months

  2. Percent change in weight

    Time frame: 6 months

  3. Dietary intake of fruits and vegetables

    Time frame: 6 months

  4. Proportion of blood pressure control

    Time frame: 9 months

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Study locations

1 site
  • NYU School of Medicine
    New York, New York 10010, United States
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References and documents

Publications

  • 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. PubMed 30354579 ↗
  • 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. PubMed 24576512 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01065831
Lead sponsor
NYU Langone Health
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Gbenga Ogedegbe (Professor of Population Health and Medicine, NYU Langone Health) — Principal investigator
First posted
Feb 9, 2010
Start date
Nov 2010
Primary completion
Jun 2014
Completion
Jun 2014
Last update
Mar 1, 2016

Study contacts

Gbenga Ogedegbe, MD
principal investigator · NYU School of Medicine
Kristie Lancaster, PhD
principal investigator · NYU Steinhardt School
Antoinette Schoenthaler, EdD
study director · NYU School of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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