title: Methods and issues in conducting a community-based environmental randomized trial.
abstract: The environment is suspected to play an important role in the prevalence and severity of asthma in inner-city children. This paper describes the implementation and baseline data of an inner-city community-based participatory research clinical trial designed to test the effectiveness of a pollutant and allergen control strategy on children's asthma morbidity. Participants were 100 elementary-school-aged children with asthma, graduates of a school-based asthma education program in East Baltimore. The intervention for half of the randomly assigned families consisted of environmental control education, allergen-proof encasements, pest extermination, and a HEPA air cleaner at the beginning of the study. Controls received the same at the end of the study. Participants visited a clinic for questionnaires, allergy skin testing, spirometry, and blood sample at baseline and 12 months. Home environments, NO(2), O(3), airborne particulates, and allergens were evaluated at baseline and at 6 and 12 months. Asthma morbidity and adherence was assessed quarterly. Collaboration with the community proved very beneficial in creating a study design and procedures acceptable to an inner-city community.
authors.affiliation: Department of Pediatrics, School of Medicine, Johns Hopkins University, CMSC 1102 600 N Wolfe Street, Baltimore, MD 21287-3923, USA.
authors.forename: Lee J
authors.initials: LJ
authors.lastname: Swartz
authors.forename: Karen A
authors.initials: KA
authors.lastname: Callahan
authors.forename: Arlene M
authors.initials: AM
authors.lastname: Butz
authors.forename: Cynthia S
authors.initials: CS
authors.lastname: Rand
authors.forename: Sukon
authors.initials: S
authors.lastname: Kanchanaraksa
authors.forename: Gregory B
authors.initials: GB
authors.lastname: Diette
authors.forename: Jerry A
authors.initials: JA
authors.lastname: Krishnan
authors.forename: Patrick N
authors.initials: PN
authors.lastname: Breysse
authors.forename: Timothy J
authors.initials: TJ
authors.lastname: Buckley
authors.forename: Adrian M
authors.initials: AM
authors.lastname: Mosley
authors.forename: Peyton A
authors.initials: PA
authors.lastname: Eggleston
mesh_terms: D016902:Air Pollution, Indoor / Q000009:adverse effects / Q000517:prevention & control; D001249:Asthma / Q000453:epidemiology*; D002648:Child; D004781:Environmental Exposure; D006801:Humans; D008396:Maryland / Q000453:epidemiology; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D018570:Risk Assessment; D014504:Urban Health