TY - JOUR
T1 - A practice-based trial of blood pressure control in African Americans (TLC-Clinic)
T2 - study protocol for a randomized controlled trial
AU - Schoenthaler, Antoinette
AU - Luerassi, Leanne
AU - Teresi, Jeanne A.
AU - Silver, Stephanie
AU - Kong, Jian
AU - Odedosu, Taiye
AU - Trilling, Samantha
AU - Errico, Anna
AU - Uvwo, Oshevire
AU - Sebek, Kimberly
AU - Adekoya, Adetutu
AU - Ogedegbe, Gbenga
N1 - Funding Information:
The authors would like to thank the team of research assistants and health educators for their work on the project: Samantha Trilling, B.A.; Anna Errico, B.S.; Oshevire Uvwo, M.D.; Adetutu Adekoya, B.A.; Kimberley Sebek, M.P.H.; Maria Ferrera, M.D.; France De La Calle, B.A.; Miguel Barrios, M.D.; Christine Subryan, B.S.; Naa-Solo Tettey, Ed.D.; Chevonne Cato, M.P.H.; Sheba King, M.P. H.; and Rita Baron-Faust, M.P.H. The Data Coordinating Center at the Research Division of the Hebrew Home at Riverdale also acknowledges Joseph P. Eimicke and Onie Manzano for their biostatistical and technical support of this project, as well as several other support staff. Dr. Ogedegbe was supported by NHLBI grant number R01 HL087301-01A2 (PI: Ogedegbe) and by NIH/NCRR NYU-CTSI Grant Number 1UL1RR029893-0109, NIH, Bethesda, MD, USA. The funding bodies played no role in the study conception or design, writing of the manuscript, and decision to submit the manuscript for publication.
PY - 2011/12/22
Y1 - 2011/12/22
N2 - 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.
AB - 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.
KW - African american
KW - Hypertension
KW - Practice-based trial
KW - Therapeutic lifestyle changes
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UR - http://www.scopus.com/inward/citedby.url?scp=84055219458&partnerID=8YFLogxK
U2 - 10.1186/1745-6215-12-265
DO - 10.1186/1745-6215-12-265
M3 - Article
C2 - 22192273
AN - SCOPUS:84055219458
SN - 1745-6215
VL - 12
JO - Trials
JF - Trials
M1 - 265
ER -