Devin L Brown1, Kathleen M Conley2, Brisa N Sánchez2, Kenneth Resnicow2, Joan E Cowdery2, Emma Sais2, Jillian Murphy2, Lesli E Skolarus2, Lynda D Lisabeth2, Lewis B Morgenstern2. 1. 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. 2. 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.
Abstract
BACKGROUND AND PURPOSE: 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. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01378780.
RCT Entities:
BACKGROUND AND PURPOSE: 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. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01378780.
Authors: Devin L Brown; Kathleen M Conley; Kenneth Resnicow; Jillian Murphy; Brisa N Sánchez; Joan E Cowdery; Emma Sais; Lynda D Lisabeth; Lesli E Skolarus; Darin B Zahuranec; Geoffrey C Williams; Lewis B Morgenstern Journal: Contemp Clin Trials Date: 2012-03-06 Impact factor: 2.226
Authors: Laura K Cobb; Cheryl A M Anderson; Paul Elliott; Frank B Hu; Kiang Liu; James D Neaton; Paul K Whelton; Mark Woodward; Lawrence J Appel Journal: Circulation Date: 2014-02-10 Impact factor: 29.690
Authors: Carlos J Rodriguez; Matthew Allison; Martha L Daviglus; Carmen R Isasi; Colleen Keller; Enrique C Leira; Latha Palaniappan; Ileana L Piña; Sarah M Ramirez; Beatriz Rodriguez; Mario Sims Journal: Circulation Date: 2014-07-14 Impact factor: 29.690
Authors: Lewis B Morgenstern; Melinda A Smith; Brisa N Sánchez; Devin L Brown; Darin B Zahuranec; Nelda Garcia; Kevin A Kerber; Lesli E Skolarus; William J Meurer; James F Burke; Eric E Adelman; Jonggyu Baek; Lynda D Lisabeth Journal: Ann Neurol Date: 2013-08-13 Impact factor: 10.422
Authors: Gbenga Ogedegbe; William Chaplin; Antoinette Schoenthaler; David Statman; David Berger; Tabia Richardson; Erica Phillips; Jacqueline Spencer; John P Allegrante Journal: Am J Hypertens Date: 2008-07-24 Impact factor: 2.689
Authors: Eric M Cheng; William E Cunningham; Amytis Towfighi; Nerses Sanossian; Robert J Bryg; Thomas L Anderson; Frances Barry; Susan M Douglas; Lillie Hudson; Monica Ayala-Rivera; Jeffrey J Guterman; Sandra Gross-Schulman; Sylvia Beanes; Andrea S Jones; Honghu Liu; Barbara G Vickrey Journal: Circ Cardiovasc Qual Outcomes Date: 2018-01
Authors: Lewis B Morgenstern; Brisa N Sánchez; Kathleen M Conley; Melany C Morgenstern; Emma Sais; Lesli E Skolarus; Deborah A Levine; Devin L Brown Journal: J Stroke Cerebrovasc Dis Date: 2016-06-21 Impact factor: 2.136
Authors: Mellanie V Springer; Kathleen M Conley; Brisa N Sanchez; Ken Resnicow; Joan E Cowdery; Lesli E Skolarus; Lewis B Morgenstern; Devin L Brown Journal: J Relig Health Date: 2021-03-09