Faith-based Approaches in the Treatment of Hypertension (FAITH)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 373
- 试验地点
- 1
- 主要终点
- Within-individual change in systolic blood pressure and diastolic blood pressure
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Motivational interviewing (MINT-TLC) (Behavioral)
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.
干预措施: Motivational interviewing (MINT-TLC) (Behavioral)
结局指标
主要结局
Within-individual change in systolic blood pressure and diastolic blood pressure
时间窗: 6 months
次要结局
- Percent change in weight(6 months)
- Levels of physical activity(6 months)
- Dietary intake of fruits and vegetables(6 months)
- Proportion of blood pressure control(9 months)
研究者
Gbenga Ogedegbe
Professor of Population Health and Medicine
NYU Langone Health