- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00005396
Motivating Smokers--Reduce Child Environmental Tobacco Smoke Exposure
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
BACKGROUND:
The study tested the hypothesis that motivational intervention would yield greater reduction in smoking-related indices, compared to a usual care comparison condition. The study also predicted that the motivational intervention would differentially impact on cognitive and behavioral mediating mechanisms that accelerate behavior change and maintenance. Finally, the study tested the hypothesis that the motivational intervention would yield greater reduction in household exposure to environmental tobacco smoke (ETS), and therefore would also result in a significantly reduced number of children's respiratory illnesses.
DESIGN NARRATIVE:
This study utilized a community health center that served a low SES population in Rhode Island. The population was approximately 40 percent Hispanic and 45 percent Caucasian. Subjects were randomized to two intervention conditions:(1) a motivational intervention, that utilized self-help, telephone counselor calls, and motivational interviewing to provide feedback about children's health status and household concentrations of nicotine; (2) usual care, which included provision of self-help materials only. A repeated measures design was used (baseline, 3- and 6-month follow-ups). Outcome measures included household nicotine concentrations, movement through the stages of readiness to change, smoking cessation attempts, point-prevalence abstinence rates, and children's health status.
Several important public health priorities for research in lung health and prevention were targeted in this study, including: (1) reduction of ETS exposure among children from low income families, a group that has had a particularly high prevalence of chronic ETS exposure;. (2) development and evaluation of an intervention that was specifically tailored to match the characteristics of smokers who were low in motivation to quit smoking, a group that constituted 80 percent of the lower SES smoking population, yet that had been largely ignored in smoking research; (3) smoking intervention with an underserved, low-income and ethnic population that had poor access to standard approaches to smoking cessation and a particularly high smoking prevalence (household smoking prevalence = 60 percent); and (4) assessment of the impact of reductions in household ETS exposure on the respiratory health of children in the context of a longitudinal study.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Studietyp
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Studieplan
Hur är studien utformad?
Samarbetspartners och utredare
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 4304
- R01HL054351 (U.S.S. NIH-anslag/kontrakt)
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