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

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, 12:265

First Online: 22 December 2011Received: 15 September 2011Accepted: 22 December 2011DOI: 10.1186-1745-6215-12-265

Cite this article as: Schoenthaler, A., Luerassi, L., Teresi, J.A. et al. Trials 2011 12: 265. doi:10.1186-1745-6215-12-265


BackgroundPoorly 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-DesignThis 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.

DiscussionThis 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 RegistrationClinicaltrials.gov NCT01070056

KeywordsHypertension African American Therapeutic Lifestyle Changes Practice-based trial List of abbreviations usedHTNHypertension

TLCTherapeutic lifestyle changes BP: Blood pressure

MINTMotivational Interviewing

UCUsual care

RCTRandomized control trial

DASHDietary Approaches to Stop Hypertension

TONETrial of Nonpharmacologic Interventions in the Elderly

HELPHealthy Eating and Lifestyle Program

JNCJoint National Committee

BHCBellevue Hospital Center

RAResearch assistant

EMRElectronic medical record

SBPSystolic blood pressure

DBPDiastolic blood pressure

CARE-DIAGComprehensive Assessment and Referral Evaluation Dementia Diagnostic Scale

FFQFood Frequency Questionnaire

CCICharlson Comorbidity Index

VIFVariance inflation factor

CIConfidence Interval.

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Author: Antoinette Schoenthaler - Leanne Luerassi - Jeanne A Teresi - Stephanie Silver - Jian Kong - Taiye Odedosu - Samantha Tril

Source: https://link.springer.com/

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