title: A Multicomponent Behavioral Intervention to Reduce Stroke Risk Factor Behaviors: The Stroke Health and Risk Education Cluster-Randomized Controlled Trial.
abstract: OBJECTIVE
  The Stroke Health and Risk Education Project was a cluster-randomized, faith-based, culturally sensitive, theory-based multicomponent behavioral intervention trial to reduce key stroke risk factor behaviors in Hispanics/Latinos and European Americans.
  
  
  METHODS
  Ten Catholic churches were randomized to intervention or control group. The intervention group received a 1-year multicomponent intervention (with poor adherence) that included self-help materials, tailored newsletters, and motivational interviewing counseling calls. Multilevel modeling, accounting for clustering within subject pairs and parishes, was used to test treatment differences in the average change since baseline (ascertained at 6 and 12 months) in dietary sodium, fruit and vegetable intake, and physical activity, measured using standardized questionnaires. A priori, the trial was considered successful if any one of the 3 outcomes was significant at the 0.05/3 level.
  
  
  RESULTS
  Of 801 subjects who consented, 760 completed baseline data assessments, and of these, 86% completed at least one outcome assessment. The median age was 53 years; 84% subjects were Hispanic/Latino; and 64% subjects were women. The intervention group had a greater increase in fruit and vegetable intake than the control group (0.25 cups per day [95% confidence interval: 0.08, 0.42], P=0.002), a greater decrease in sodium intake (-123.17 mg/d [-194.76, -51.59], P=0.04), but no difference in change in moderate- or greater-intensity physical activity (-27 metabolic equivalent-minutes per week [-526, 471], P=0.56).
  
  
  CONCLUSIONS
  This multicomponent behavioral intervention targeting stroke risk factors in predominantly Hispanics/Latinos was effective in increasing fruit and vegetable intake, reaching its primary end point. The intervention also seemed to lower sodium intake. Church-based health promotions can be successful in primary stroke prevention efforts.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT01378780.
authors.affiliation: From the Department of Neurology, Stroke Program, University of Michigan, Ann Arbor (D.L.B., E.S., J.M., L.E.S., L.D.L., L.B.M.); Program of Health Education, School of Health Promotion and Human Performance, Eastern Michigan University, Ypsilanti (K.M.C., J.E.C.); and Departments of Biostatistics (B.N.S.), Health Behavior and Health Education (K.R.), and Epidemiology (L.D.L., L.B.M.), University of Michigan School of Public Health, Ann Arbor. devinb@umich.edu.
authors.forename: Devin L
authors.initials: DL
authors.lastname: Brown
authors.affiliation: From the Department of Neurology, Stroke Program, University of Michigan, Ann Arbor (D.L.B., E.S., J.M., L.E.S., L.D.L., L.B.M.); Program of Health Education, School of Health Promotion and Human Performance, Eastern Michigan University, Ypsilanti (K.M.C., J.E.C.); and Departments of Biostatistics (B.N.S.), Health Behavior and Health Education (K.R.), and Epidemiology (L.D.L., L.B.M.), University of Michigan School of Public Health, Ann Arbor.
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: Conley
authors.affiliation: From the Department of Neurology, Stroke Program, University of Michigan, Ann Arbor (D.L.B., E.S., J.M., L.E.S., L.D.L., L.B.M.); Program of Health Education, School of Health Promotion and Human Performance, Eastern Michigan University, Ypsilanti (K.M.C., J.E.C.); and Departments of Biostatistics (B.N.S.), Health Behavior and Health Education (K.R.), and Epidemiology (L.D.L., L.B.M.), University of Michigan School of Public Health, Ann Arbor.
authors.forename: Brisa N
authors.initials: BN
authors.lastname: Sánchez
authors.affiliation: From the Department of Neurology, Stroke Program, University of Michigan, Ann Arbor (D.L.B., E.S., J.M., L.E.S., L.D.L., L.B.M.); Program of Health Education, School of Health Promotion and Human Performance, Eastern Michigan University, Ypsilanti (K.M.C., J.E.C.); and Departments of Biostatistics (B.N.S.), Health Behavior and Health Education (K.R.), and Epidemiology (L.D.L., L.B.M.), University of Michigan School of Public Health, Ann Arbor.
authors.forename: Kenneth
authors.initials: K
authors.lastname: Resnicow
authors.affiliation: From the Department of Neurology, Stroke Program, University of Michigan, Ann Arbor (D.L.B., E.S., J.M., L.E.S., L.D.L., L.B.M.); Program of Health Education, School of Health Promotion and Human Performance, Eastern Michigan University, Ypsilanti (K.M.C., J.E.C.); and Departments of Biostatistics (B.N.S.), Health Behavior and Health Education (K.R.), and Epidemiology (L.D.L., L.B.M.), University of Michigan School of Public Health, Ann Arbor.
authors.forename: Joan E
authors.initials: JE
authors.lastname: Cowdery
authors.affiliation: From the Department of Neurology, Stroke Program, University of Michigan, Ann Arbor (D.L.B., E.S., J.M., L.E.S., L.D.L., L.B.M.); Program of Health Education, School of Health Promotion and Human Performance, Eastern Michigan University, Ypsilanti (K.M.C., J.E.C.); and Departments of Biostatistics (B.N.S.), Health Behavior and Health Education (K.R.), and Epidemiology (L.D.L., L.B.M.), University of Michigan School of Public Health, Ann Arbor.
authors.forename: Emma
authors.initials: E
authors.lastname: Sais
authors.affiliation: From the Department of Neurology, Stroke Program, University of Michigan, Ann Arbor (D.L.B., E.S., J.M., L.E.S., L.D.L., L.B.M.); Program of Health Education, School of Health Promotion and Human Performance, Eastern Michigan University, Ypsilanti (K.M.C., J.E.C.); and Departments of Biostatistics (B.N.S.), Health Behavior and Health Education (K.R.), and Epidemiology (L.D.L., L.B.M.), University of Michigan School of Public Health, Ann Arbor.
authors.forename: Jillian
authors.initials: J
authors.lastname: Murphy
authors.affiliation: From the Department of Neurology, Stroke Program, University of Michigan, Ann Arbor (D.L.B., E.S., J.M., L.E.S., L.D.L., L.B.M.); Program of Health Education, School of Health Promotion and Human Performance, Eastern Michigan University, Ypsilanti (K.M.C., J.E.C.); and Departments of Biostatistics (B.N.S.), Health Behavior and Health Education (K.R.), and Epidemiology (L.D.L., L.B.M.), University of Michigan School of Public Health, Ann Arbor.
authors.forename: Lesli E
authors.initials: LE
authors.lastname: Skolarus
authors.affiliation: From the Department of Neurology, Stroke Program, University of Michigan, Ann Arbor (D.L.B., E.S., J.M., L.E.S., L.D.L., L.B.M.); Program of Health Education, School of Health Promotion and Human Performance, Eastern Michigan University, Ypsilanti (K.M.C., J.E.C.); and Departments of Biostatistics (B.N.S.), Health Behavior and Health Education (K.R.), and Epidemiology (L.D.L., L.B.M.), University of Michigan School of Public Health, Ann Arbor.
authors.forename: Lynda D
authors.initials: LD
authors.lastname: Lisabeth
authors.affiliation: From the Department of Neurology, Stroke Program, University of Michigan, Ann Arbor (D.L.B., E.S., J.M., L.E.S., L.D.L., L.B.M.); Program of Health Education, School of Health Promotion and Human Performance, Eastern Michigan University, Ypsilanti (K.M.C., J.E.C.); and Departments of Biostatistics (B.N.S.), Health Behavior and Health Education (K.R.), and Epidemiology (L.D.L., L.B.M.), University of Michigan School of Public Health, Ann Arbor.
authors.forename: Lewis B
authors.initials: LB
authors.lastname: Morgenstern
mesh_terms: D000328:Adult; D000368:Aged; D001521:Behavior Therapy / Q000379:methods; D002410:Catholicism; D005247:Feeding Behavior; D005260:Female; D005638:Fruit; D015438:Health Behavior; D006630:Hispanic or Latino; D006801:Humans; D008297:Male; D008875:Middle Aged; D062405:Motivational Interviewing / Q000379:methods*; D009043:Motor Activity; D055361:Multilevel Analysis; D010353:Patient Education as Topic; D040242:Risk Reduction Behavior; D012648:Self Care; D012982:Sodium, Dietary; D020521:Stroke / Q000517:prevention & control*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014675:Vegetables; D044465:White People
chemical_list: D012982:Sodium, Dietary
keywords: behavioral intervention; clinical trial; hypertension; prevention; risk factors; stroke