- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT00927264
PRIDE: Preventing Respiratory Illnesses During Childhood Study (PRIDE)
A+ Head Start Intervention for Smoke Free Homes
Tutkimuksen yleiskatsaus
Tila
Ehdot
Yksityiskohtainen kuvaus
About 90% of nonsmoking people in the US are exposed to ETS. More than 50 chemicals identified in ETS have been found to cause cancer and exposure has been linked to heart disease in adults and SIDS, ear infections and numerous respiratory problems, including asthma in children. In 2007, the Environmental Protection Agency and the Office of Head Start-a national program that provides economically disadvantaged children services to enhance their social and cognitive development-announced a new initiative to promote smoke-free homes for children in Head Start programs. Because Head Start reaches high-risk, low-income preschool children, it offers a timely intervention for reducing children's exposure to ETS. Head Start also attempts to engage parents, which is an important component of reducing household ETS exposure among children. This study will determine the effectiveness of a home-delivered, motivational interviewing-based program in reducing ETS exposure and improving lung health among children who are enrolled in the Baltimore City Head Start program and whose households include a smoker.
Participation in this study will last 1 year. First, all participating families will be visited at home by a study staff person who will attach special filters that will track the amount of nicotine in the various rooms of the house. During this initial visit, the participating children will undergo weight and height measurements and saliva sampling. About a week later, the filters will be collected, a 2nd saliva samples will be taken and parents will be interviewed about their family and child's health. Families will then be randomly assigned to one of two groups. Both groups will received educational information about reducing tobacco smoke exposure. One group will also receive the home-delivered, motivational interviewing-based program aimed to reduce ETS. This program will consist of 2 home visits and 2 phone calls, both led by health counselor who will teach participants how to reduce their child's exposure to tobacco smoke. The home visits will occur during Weeks 1 & 2 and the phone calls will occur during Weeks 3 & 6. Follow-up visits for all participating families will occur at Months 3,6 and 12 and will involve repeat filter testing, saliva monitoring and interviews.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Maryland
-
Baltimore, Maryland, Yhdysvallat, 21206
- Johns Hopkins University
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- Child enrolled in Baltimore City Head Start
- Smoker living in the home with child
Exclusion Criteria:
- No smoker in home with child
- Does not speak English
- Is enrolled in other respiratory research study
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Tehtävätehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: Behavioral
Motivational Interviewing Intervention Plus Education Caregivers will receive a home-based motivational interviewing intervention for ETS reduction plus an educational program for ETS reduction. |
The intervention is designed to motivate caregivers to reduce a child's ETS exposure by establishing a complete home and car smoking ban and by considering smoking cessation.
Caregivers will receive 2 home visits & 2 telephone session, both with a health counselor.
Caregivers will be provided with feedback on air nicotine levels and child salivary cotinine levels.
The main target for the intervention will be the primary caregiver of the child because the primary caregiver is ultimately responsible for protecting the child from ETS exposure.
Any and all household members may participate in the intervention visits but are not required to do so.
|
|
Active Comparator: Education Only
Caregivers will receive only educational program for ETS reduction.
|
An Environmental Protection Agency-based educational program that will consist of information about reducing tobacco smoke exposure.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Air Nicotine Levels
Aikaikkuna: Measured at Baseline, 3, 6 and 12 months
|
Air nicotine levels were an indicator of child's exposure to environmental tobacco smoke (ETS)
|
Measured at Baseline, 3, 6 and 12 months
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
ETS Reduction, as Measured by Child's Cotinine Levels
Aikaikkuna: Measured at Baseline, 3, 6 and 12 months
|
Child salivary cotinine will be a measure to evaluate environmental tobacco smoke (ETS) reduction
|
Measured at Baseline, 3, 6 and 12 months
|
|
Respiratory Function of Child by Self Report of Parent
Aikaikkuna: Measured at Baseline, 3, 6, and 12 months
|
Number of cold infections child experienced in previous 3 months, reported by caregiver
|
Measured at Baseline, 3, 6, and 12 months
|
|
Health Care Utilization by Child- Self Report From Parent/Caregiver
Aikaikkuna: Measured at baseline and 3, 6 and 12 months
|
Parent caregiver reported urgent care visits, number of hospitalizations, and number of emergency department visits in the 12 months prior for child enrolled in study
|
Measured at baseline and 3, 6 and 12 months
|
|
Number of Participants Who Report Endorsing a Home Smoking Ban
Aikaikkuna: Measured at baseline, 3, 6 and 12 months
|
Number of participants endorsing presence of home smoking ban
|
Measured at baseline, 3, 6 and 12 months
|
Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Cynthia S Rand, PhD, Johns Hopkins University
Julkaisuja ja hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muut tutkimustunnusnumerot
- 664
- R18HL092901-01 (Yhdysvaltain NIH-apuraha/sopimus)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .
Kliiniset tutkimukset Tupakansavun saastuminen
-
University of OklahomaNational Cancer Institute (NCI)ValmisSecondhand SmokeYhdysvallat
-
University of OklahomaValmisSecondhand SmokeYhdysvallat
-
Children's Hospital of PhiladelphiaPennsylvania Department of HealthValmis
-
Eunice Kennedy Shriver National Institute of Child...ValmisEnvironmental Tobacco Smoke (ETS)Yhdysvallat
-
The University of Hong KongHong Kong Council on Smoking and HealthValmisTupakointi | Secondhand Smoke | Kolmannen käden savuHong Kong
-
Akdeniz UniversityThe Scientific and Technological Research Council of TurkeyValmisLapsi | Vanhemmat | Virtsa | Altistuminen ympäristön saastumiselle | Second Hand SmokeTurkki
-
Oregon Health and Science UniversityNational Heart, Lung, and Blood Institute (NHLBI); Office of Dietary Supplements...ValmisSecond Hand Smoke | Keuhkojen toiminta; Vastasyntynyt, epänormaali | Infant Wheeze | Kohdun sisäinen nikotiiniYhdysvallat
-
University of AarhusAarhus University HospitalValmisElektronisen savukkeen käyttö | Keuhkojen toiminta | Second Hand SmokeTanska
-
University of California, San FranciscoFlight Attendant Medical Research InstituteAktiivinen, ei rekrytointiHyperinflaatio | Tupakka | Obstruktiivinen keuhkosairaus | Secondhand Smoke | Ilmanpysäytys | Ilmavirran rajoitusYhdysvallat