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

NCT01065831 | Completed DMC

• 2 other identifiers: FAITH 09-05581R01HL092860-01A1
• Study Type: interventional
• Target: 373
• Locations: 1 country
• Sites: 1

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).

Conditions

Hypertension

Keywords

motivational interviewing, lay health advisers

Outcome Measures

Primary Outcomes (1)

• Within-individual change in systolic blood pressure and diastolic blood pressure

  6 months

Secondary Outcomes (4)

• Levels of physical activity

  6 months

• Percent change in weight

  6 months

• Dietary intake of fruits and vegetables

  6 months

• Proportion of blood pressure control

  9 months

Study Arms (2)

Lifestyle counseling

EXPERIMENTAL

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)

Health Education Control Condition

PLACEBO COMPARATOR

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

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.

Also known as: Church-based lifestyle intervention, FAITH

Health Education Control Condition; Lifestyle counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

NYU School of Medicine

New York, New York, 10010, United States

Location

Related Publications (2)

• 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.

  PMID: 30354579 DERIVED

• 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.

  PMID: 24576512 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Gbenga Ogedegbe, MD

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

• Kristie Lancaster, PhD

  NYU Steinhardt School

  PRINCIPAL INVESTIGATOR

• Antoinette Schoenthaler, EdD

  NYU School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Population Health and Medicine

Study Record Dates

• First Submitted: February 8, 2010
• First Posted: February 9, 2010
• Study Start: November 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: March 1, 2016

Record last verified: 2016-02

Locations

US (1)