A practice-based trial of blood pressure control in African Americans (TLC-Clinic): study protocol for a randomized controlled trial

Trials

Gbenga Ogedegbe³  Adetutu Adekoya³  Kimberly Sebek³  Oshevire Uvwo³  Anna Errico³  Samantha Trilling³  Taiye Odedosu²  Jian Kong¹  Stephanie Silver¹  Jeanne A Teresi⁴  Leanne Luerassi³  Antoinette Schoenthaler³ 

[1] Research Division, Hebrew Home at Riverdale, New York, NY;Bellevue Adult Primacy Care Practice, Bellevue Hospital Center, New York, NY;Center for Healthful Behavior Change, New York University School of Medicine, Department of Medicine, Division of General Internal Medicine, New York, NY;Columbia University Stroud Center, Faculty of Medicine and New York State Psychiatric Institute, New York, NY

关键词: Practice-based trial;    Therapeutic Lifestyle Changes;    African American;    Hypertension;   

Others  :  1095725
DOI  :  10.1186/1745-6215-12-265

 received in 2011-09-15, accepted in 2011-12-22,  发布年份 2011

【 摘 要 】

Background

Poorly controlled hypertension (HTN) remains one of the most significant public health problems in the United States, in terms of morbidity, mortality, and economic burden. Despite compelling evidence supporting the beneficial effects of therapeutic lifestyle changes (TLC) for blood pressure (BP) reduction, the effectiveness of these approaches in primary care practices remains untested, especially among African Americans, who share a disproportionately greater burden of HTN-related outcomes.

Methods/Design

This randomized controlled trial tests the effectiveness of a practice-based comprehensive therapeutic lifestyle intervention, delivered through group-based counseling and motivational interviewing (MINT-TLC) versus Usual Care (UC) in 200 low-income, African Americans with uncontrolled hypertension. MINT-TLC is designed to help patients make appropriate lifestyle changes and develop skills to maintain these changes long-term. Patients in the MINT-TLC group attend 10 weekly group classes focused on healthy lifestyle changes (intensive phase); followed by 3 monthly individual motivational interviewing (MINT) sessions (maintenance phase). The intervention is delivered by trained research personnel with appropriate treatment fidelity procedures. Patients in the UC condition receive a single individual counseling session on healthy lifestyle changes and print versions of the intervention materials. The primary outcome is within-patient change in both systolic and diastolic BP from baseline to 6 months. In addition to BP control at 6 months, other secondary outcomes include changes in the following lifestyle behaviors from baseline to 6 months: a) physical activity, b) weight loss, c) number of daily servings of fruits and vegetables and d) 24-hour urinary sodium excretion.

Discussion

This vanguard trial will provide information on how to refine MINT-TLC and integrate it into a standard treatment protocol for hypertensive African Americans as a result of the data obtained; thus maximizing the likelihood of its translation into clinical practice.

Trial Registration

Clinicaltrials.gov NCT01070056

【 授权许可】

   
2011 Schoenthaler et al; licensee BioMed Central Ltd.

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