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Completed

NCT Number: NCT01065831

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).

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU School of Medicine

New York, 10010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motivational interviewing (MINT-TLC)

Behavioral

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

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

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: FAITH

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Feb 9, 2010
Registry last updated
Mar 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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