A practice-based trial of blood pressure control in African Americans (TLC-Clinic): study protocol for a randomized controlled trial
| Autor: | Kimberly Sebek, Samantha Trilling, Taiye Odedosu, Oshevire Uvwo, Adetutu Adekoya, Jeanne A. Teresi, Anna Errico, Jian Kong, Stephanie Silver, Leanne Luerassi, Antoinette Schoenthaler, Gbenga Ogedegbe |
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| Jazyk: | angličtina |
| Rok vydání: | 2011 |
| Předmět: |
Gerontology
Blood pressure control Counseling medicine.medical_specialty Alternative medicine MEDLINE Medicine (miscellaneous) 030204 cardiovascular system & hematology law.invention Interviews as Topic 03 medical and health sciences Study Protocol 0302 clinical medicine Randomized controlled trial Clinical Protocols law Medicine Humans Pharmacology (medical) 030212 general & internal medicine Intensive care medicine African American Life Style Protocol (science) lcsh:R5-920 Motivation business.industry Practice-based trial Public health 3. Good health Black or African American Blood pressure Treatment Outcome Sample Size Hypertension Therapeutic Lifestyle Changes business lcsh:Medicine (General) |
| Zdroj: | Trials Trials, Vol 12, Iss 1, p 265 (2011) |
| ISSN: | 1745-6215 |
| Popis: | 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 |
| Databáze: | OpenAIRE |
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