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Design and baseline characteristics of a low-income urban cohort of children with asthma: The Asthma Action at Erie Trial.

ABSTRACT: OBJECTIVE:To describe the methodology of a randomized controlled trial comparing the efficacy of integrated asthma community health workers (CHW) and a certified asthma educator (AE-C) to improve asthma outcomes in low-income minority children in Chicago. METHODS:Child/caregiver dyads were randomized to CHW home visits or education in the clinic from an AE-C. Intervention was delivered in the first year after enrollment. Data collection occured at baseline, 6-, 12-, 18, and 24-months. The co-primary outcomes included asthma control using the Asthma Control Test/childhood Asthma Control Test (ACT/cACT) and activity limitation over the past 14?days. RESULTS:A total of 223 participants ages 5-16?years were randomized. The majority of children were in the 5-11?year old range (78.9%). Most caregivers (96.9%) and 44% of children were female. Approximately 85% of caregivers and children reported Hispanic ethnicity and 62.3% reported a household income of???$59,000. Over half (55.7%) had uncontrolled asthma as measured by ACT/cACT; 13.9% had a normal ACT/cACT score but were uncontrolled using the Asthma Control Questionnaire and 20.2% were controlled on both measures but had received oral steroids in the past year for asthma. CONCLUSION:The Asthma Action at Erie Trial successfully recruited a largely Hispanic cohort of children with uncontrolled or high-risk asthma to study the differential effects of clinic-based AE-C and home-based CHW interventions. Strengths of the trial include its comparative effectivness design that integrates interventionists and intervention delivery into a clinical setting. Categorizing asthma control in community settings for research purposes presents unique challenges. CLINICAL TRIAL REGISTRATION:University of Illinois at Chicago Protocol Record R01HL123797, Asthma Action at Erie TrialClinicalTrials.gov Identifier: NCT02481986 "ClinicalTrials.gov Registration" register@clinicaltrials.gov.

SUBMITTER: Mosnaim GS

PROVIDER: S-EPMC6541387 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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Design and baseline characteristics of a low-income urban cohort of children with asthma: The Asthma Action at Erie Trial.

Mosnaim Giselle S GS Weinstein Sally M SM Pugach Oksana O Rosales Genesis G Roy Angkana A Walton Surrey S Martin Molly A MA

Contemporary clinical trials 20190214

<h4>Objective</h4>To describe the methodology of a randomized controlled trial comparing the efficacy of integrated asthma community health workers (CHW) and a certified asthma educator (AE-C) to improve asthma outcomes in low-income minority children in Chicago.<h4>Methods</h4>Child/caregiver dyads were randomized to CHW home visits or education in the clinic from an AE-C. Intervention was delivered in the first year after enrollment. Data collection occured at baseline, 6-, 12-, 18, and 24-mon ...[more]

PMID: 30772471

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Project description:Traditional measures of socioeconomic status (SES) are associated with asthma morbidity, but their specific contributions are unclear. Increased exposure to indoor allergens among low SES children is an important consideration. Material hardship, a concept describing poor access to basic goods and services, may explain the relationship between low SES and indoor allergen exposure, and thereby, the increased risk of asthma morbidity. We sought to (i) describe the specific hardships experienced by low-Income, urban, minority children with asthma and indoor allergen sensitization and (ii) determine if material hardship is associated with indoor allergen exposure in this population. We conducted a cross-sectional analysis of children undergoing the baseline assessment for a clinical trial of home environmental modification. Participants were scored in five domains of material hardship. Domain scores were assigned based on caregiver responses to a questionnaire and were summed to generate a total material hardship score. Linear regression was used to examine the relationship between material hardship scores and bedroom floor concentrations of five common indoor allergens. Participants experienced high levels of material hardship in each of the five domains, with 33% not having access to a car, 35% not being able to pay utility bills, and 28% not being able to pay rent in the past year. Each one-point increase in material hardship was associated with an increase in cockroach allergen of 16.2% (95% CI 9.4%, 24.6%) and an increase in mouse allergen of 9.4% (95% CI 1.0%, 18.5%). After adjusting for traditional measures of SES, including household income, health insurance type, caregiver education, and caregiver employment status, the association between material hardship and cockroach allergen, but not mouse allergen, remained. These data suggest that a significant proportion of families of low-income, minority children with asthma may experience material hardship, and that they may be at greater risk of cockroach allergen exposure than their peers with similar income, but without material hardship.

Project description:BackgroundYouth problem behaviors remain a public health issue. Youth in low-income, urban areas are particularly at risk for engaging in aggressive, violent, and disruptive behaviors.PurposeTo evaluate the effects of a school-based social-emotional learning and health promotion program on problem behaviors and related attitudes among low-income, urban youth.DesignA matched-pair, cluster RCT.Setting/participantsParticipants were drawn from 14 Chicago Public Schools over a 6-year period of program delivery with outcomes assessed for a cohort of youth followed from Grades 3 to 8. Data were collected from Fall 2004 to Spring 2010, and analyzed in Spring 2012.InterventionThe Positive Action program includes a scoped and sequenced K-12 classroom curriculum with six components: self-concept, social and emotional positive actions for managing oneself responsibly, and positive actions directed toward physical and mental health, honesty, getting along with others, and continually improving oneself. The program also includes teacher, counselor, family, and community training as well as activities directed toward schoolwide climate development.Main outcome measuresYouth reported on their normative beliefs in support of aggression and on their bullying, disruptive, and violent behaviors; parents rated youths' bullying behaviors and conduct problems; schoolwide data on disciplinary referrals and suspensions were obtained from school records.ResultsMultilevel growth-curve modeling analyses conducted on completion of the trial indicated that Positive Action mitigated increases over time in (1) youth reports of normative beliefs supporting aggressive behaviors and of engaging in disruptive behavior and bullying (girls only) and (2) parent reports of youth bullying behaviors (boys only). At study end-point, students in Positive Action schools also reported a lower rate of violence-related behavior than students in control schools. Schoolwide findings indicated positive program effects on both disciplinary referrals and suspensions. Program effect sizes ranged from -0.26 to -0.68.ConclusionsThese results extend evidence of the effectiveness of the Positive Action program to low-income, minority, urban school settings, and to middle school-aged youth.

Project description:BACKGROUND:Primary care-based behavior change obesity treatment has long featured the Calorie restriction (CC), portion control approach. By contrast, the MyPlate-based obesity treatment approach encourages eating more high-satiety/high-satiation foods and requires no calorie-counting. This report describes study methods of a comparative effectiveness trial of CC versus MyPlate. It also describes baseline findings involving demographic characteristics and their associations with primary outcome measures and covariates, including satiety/satiation, dietary quality and acculturation. METHODS:A comparative effectiveness trial was designed to compare the CC approach (n?=?130) versus a MyPlate-based approach (n?=?131) to treating patient overweight. Intervenors were trained community health workers. The 11 intervention sessions included two in-home health education sessions, two group education sessions, and seven telephone coaching sessions. Questionnaire and anthropometric assessments occurred at baseline, 6- and 12?months; food frequency questionnaires were administered at baseline and 12?months. Participants were overweight adult primary care patients of a federally qualified health center in Long Beach, California. Two measures of satiety/satiation and one measure of post-meal hunger comprised the primary outcome measures. Secondary outcomes included weight, waist circumference, blood pressure, dietary quality, sugary beverage intake, water intake, fruit and vegetable fiber intake, mental health and health-related quality of life. Covariates included age, gender, nativity status (U.S.-born, not U.S.-born), race/ethnicity, education, and acculturation. ANALYSIS:Baseline characteristics were compared using chi square tests. Associations between covariates and outcome measures were evaluated using multiple regression and logistic regression. RESULTS:Two thousand eighty-six adult patients were screened, yielding 261 enrollees who were 86% Latino, 8% African American, 4% White and 2% Other. Women predominated (95%). Mean age was 42?years. Most (82%) were foreign-born; 74% chose the Spanish language option. Mean BMI was 33.3?kg/m2; mean weight was 82?kg; mean waist circumference was 102?cm. Mean blood pressure was 122/77?mm. Study arms on key baseline measures did not differ except on dietary quality and sugary beverage intake. Nativity status was significantly associated with dietary quality. CONCLUSIONS:The two treatment arms were well-balanced demographically at baseline. Nativity status is inversely related to dietary quality. TRIAL REGISTRATION:NCT02514889 , posted on 8/4/2015.

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Design and baseline characteristics of a low-income urban cohort of children with asthma: The Asthma Action at Erie Trial.

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Design and baseline characteristics of a low-income urban cohort of children with asthma: The Asthma Action at Erie Trial.

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