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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: Motivational interviewing (MINT-TLC)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle counseling<br>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)<br>* 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.<br>* Other names: FAITH;|
| Placebo Comparator: Health Education Control Condition<br>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)<br>* 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.<br>* Other names: FAITH;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Within-individual change in systolic blood pressure and diastolic blood pressure |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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motivational interviewing, lay health advisers