title: A practice-based trial of blood pressure control in African Americans (TLC-Clinic): study protocol for a randomized controlled trial.
abstract: 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT01070056.
authors.affiliation: Center for Healthful Behavior Change, New York University School of Medicine, Department of Medicine, Division of General Internal Medicine, New York, NY, USA. Antoinette.Schoenthaler@nyumc.org
authors.forename: Antoinette
authors.initials: A
authors.lastname: Schoenthaler
authors.forename: Leanne
authors.initials: L
authors.lastname: Luerassi
authors.forename: Jeanne A
authors.initials: JA
authors.lastname: Teresi
authors.forename: Stephanie
authors.initials: S
authors.lastname: Silver
authors.forename: Jian
authors.initials: J
authors.lastname: Kong
authors.forename: Taiye
authors.initials: T
authors.lastname: Odedosu
authors.forename: Samantha
authors.initials: S
authors.lastname: Trilling
authors.forename: Anna
authors.initials: A
authors.lastname: Errico
authors.forename: Oshevire
authors.initials: O
authors.lastname: Uvwo
authors.forename: Kimberly
authors.initials: K
authors.lastname: Sebek
authors.forename: Adetutu
authors.initials: A
authors.lastname: Adekoya
authors.forename: Gbenga
authors.initials: G
authors.lastname: Ogedegbe
mesh_terms: D001741:Black or African American; D002985:Clinical Protocols; D003376:Counseling; D006801:Humans; D006973:Hypertension / Q000628:therapy*; D007407:Interviews as Topic; D008019:Life Style; D009042:Motivation; D018401:Sample Size; D016896:Treatment Outcome