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A randomized trial of parental behavioral counseling and cotinine feedback for lowering environmental tobacco smoke exposure in children with asthma: results of the LET'S Manage Asthma trial.

ABSTRACT: Secondhand tobacco smoke exposure impairs the control of pediatric asthma. Evidence of the efficacy of interventions to reduce children's exposure and improve disease outcomes has been inconclusive.Caregivers of 519 children aged 3 to 12 years with asthma and reported smoke exposure attended two baseline assessment visits, which involved a parent interview, sampling of the children's urine (for cotinine assay), and spirometry (children?5 years). The caregivers and children (n=352) with significant documented exposure (cotinine?10 ng/mL) attended a basic asthma education session, provided a third urine sample, and were randomized to the Lowering Environmental Tobacco Smoke: LET'S Manage Asthma (LET'S) intervention (n=178) or usual care (n=174). LET'S included three in-person, stage-of-change-based counseling sessions plus three follow-up phone calls. Cotinine feedback was given at each in-person session. Follow-up visits at 6 and 12 months postrandomization repeated the baseline data collection. Multivariate regression analyses estimated the intervention effect on the natural logarithm of the cotinine to creatinine ratio (lnCCR), use of health-care services, and other outcomes.In the sample overall, the children in the LET'S intervention had lower follow-up lnCCR values compared with the children in usual care, but the group difference was not significant (? coefficient=-0.307, P=.064), and there was no group difference in the odds of having>one asthma-related medical visit (? coefficient=0.035, P=.78). However, children with high-risk asthma had statistically lower follow-up lnCCR values compared with children in usual care (? coefficient=-1.068, P=.006).The LET'S intervention was not associated with a statistically significant reduction in tobacco smoke exposure or use of health-care services in the sample as a whole. However, it appeared effective in reducing exposure in children at high risk for subsequent exacerbations.ClinicialTrials.gov; No.: NCT00217958; URL: clinicaltrials.gov.

SUBMITTER: Wilson SR

PROVIDER: S-EPMC3047287 | biostudies-literature | 2011 Mar

REPOSITORIES: biostudies-literature

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A randomized trial of parental behavioral counseling and cotinine feedback for lowering environmental tobacco smoke exposure in children with asthma: results of the LET'S Manage Asthma trial.

Wilson Sandra R SR Farber Harold J HJ Knowles Sarah B SB Lavori Philip W PW

Chest 20100923 3

<h4>Background</h4>Secondhand tobacco smoke exposure impairs the control of pediatric asthma. Evidence of the efficacy of interventions to reduce children's exposure and improve disease outcomes has been inconclusive.<h4>Methods</h4>Caregivers of 519 children aged 3 to 12 years with asthma and reported smoke exposure attended two baseline assessment visits, which involved a parent interview, sampling of the children's urine (for cotinine assay), and spirometry (children≥5 years). The caregivers ...[more]

PMID: 20864611

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Project description:ImportancePoor sleep during early childhood is associated with adverse outcomes, including obesity, cognitive impairment, and mental and behavioral disorders.ObjectiveTo assess the efficacy of an educational intervention in the promotion of nighttime sleep duration.Design, setting, and participantsThis single-blind, intent-to-treat randomized clinical trial included participants in Pelotas, Brazil, aged 3 months who were followed up until age 24 months. Eligibility criteria included healthy infants aged approximately 3 months who slept less than 15 hours per 24 hours. Infants were randomized to the intervention group or control group.InterventionsInformation on sleep characteristics, improvements in the environment, establishment of a nighttime sleep routine, and waiting before attending nocturnal awakenings was delivered to mothers in the intervention group by trained home-visitors at baseline. The intervention group received a telephone call on the first and second day after the intervention and a home visit on the third day after the intervention. The intervention's content was reinforced at health care visits for ages 6 months and 12 months. Mothers allocated to the control group were counseled on the benefits of breastfeeding for the mother's and child's health and given written material with content on breastfeeding.Main outcomes and measuresNighttime sleep duration was measured by interview and actigraphy at baseline and ages 6, 12, and 24 months and diaries at baseline and age 6 months. At ages 3 and 6 months, nighttime sleep self-regulation was calculated by subtracting nighttime sleep duration recorded by actigraphy from nighttime sleep duration recorded in the diaries and at ages 12 and 24 months by subtracting nighttime sleep duration recorded by actigraphy from nighttime sleep duration obtained by interview.ResultsAmong 1812 mother-infant dyads invited to participate, 798 met the inclusion criteria and 586 agreed to participate. The intervention group included 298 infants (154 [52.9%] boys), and the control group included 288 infants (164 [58.2%] boys). At age 6 months, mean (SD) nighttime sleep duration recorded in diaries was 9.80 (1.85) hours in the intervention group and 9.49 (2.07) hours in the control group, a difference of 19 minutes longer for the intervention group. At age 12 months, mean (SD) nighttime sleep duration based on the Brief Infant Sleep Questionnaire was 8.43 (1.35) hours in the intervention group and 8.52 (1.35) hours in the control group, a difference of 5 minutes shorter for the intervention group. At age 24 months, compared with information from the interview, actigraphy records showed that children in the intervention group stayed awake at night without signalizing for a mean (SD) of 0.52 (2.52) hours, whereas children in the control group stayed awake at night without signalizing for a mean (SD) of 0.23 (2.43) hours. There were no statistically significant difference between groups in any of the sleep parameters investigated.Conclusions and relevanceThis randomized clinical trial found that the educational intervention did not achieve longer nighttime sleep duration among infants in the intervention group.Trial registrationClinicalTrials.gov identifier: NCT02788630.

Project description:Background and aimsDue to concerns about increased exposure to nicotine, pregnant women using nicotine replacement therapy (NRT) to stop smoking are usually advised to stop using NRT if they relapse to smoking. This study investigated whether this is justified. We compared changes in saliva cotinine from baseline to 2 weeks post-target quit date pregnant smokers who relapsed to smoking and continued to use their patches having been assigned to use nicotine patches or placebo.Design and settingControlled pre-post design stratified by intervention condition from the 'Study of Nicotine Patch in Pregnancy', a randomized, placebo-controlled trial.ParticipantsA sample of 268 pregnant women, assigned placebo (n = 122) or nicotine (n = 146) patches, who returned for further supplies of patches and who reported any smoking in the week prior to a visit at 2 weeks after their target quit date.MeasurementsSaliva cotinine concentrations were measured at baseline and 2 weeks after participants' target quit dates. Any smoking in the previous week was assessed by self-report, validated by expired air carbon monoxide (CO).FindingsThere was no change in saliva cotinine concentrations between baseline and 2 weeks post-target quit date in saliva cotinine concentration in the nicotine patch group [ratio of geometric means = 0.94, 95% confidence interval (CI) = 0.83 to 1.07; P = 0.37, Bayes factor = 0.15]. However, there was a reduction in reported number of cigarettes smoked/day (mean difference -6, 95% CIs -7 to -5, P < 0.001) and in CO concentrations (mean difference -3.0 parts per million, 95% CIs -4.2 to -1.9, P < 0.001). These changes were not significantly different from changes in the placebo group except for cigarette consumption, which reduced more in the nicotine group (P = 0.046).ConclusionsIn women trying to stop smoking with the aid of a nicotine patch but having smoked at 2 weeks post-target quit, their nicotine concentration did not change from baseline, but they reported smoking fewer cigarettes and had lower carbon monoxide concentrations.

Dataset Information

A randomized trial of parental behavioral counseling and cotinine feedback for lowering environmental tobacco smoke exposure in children with asthma: results of the LET'S Manage Asthma trial.

Publications

A randomized trial of parental behavioral counseling and cotinine feedback for lowering environmental tobacco smoke exposure in children with asthma: results of the LET'S Manage Asthma trial.

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