Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00005396
Other study ID # 4304
Secondary ID R01HL054351
Status Completed
Phase N/A
First received May 25, 2000
Last updated February 17, 2016
Start date September 1994
Est. completion date August 1999

Study information

Verified date April 2002
Source National Heart, Lung, and Blood Institute (NHLBI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

To evaluate the efficacy of a motivational intervention designed to reduce children's exposure to environmental tobacco smoke in the household and to increase parental motivation towards smoking cessation.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date August 1999
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group N/A to 100 Years
Eligibility No eligibility criteria

Study Design

N/A


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (1)

Emmons KM, Hammond SK, Fava JL, Velicer WF, Evans JL, Monroe AD. A randomized trial to reduce passive smoke exposure in low-income households with young children. Pediatrics. 2001 Jul;108(1):18-24. — View Citation

See also
  Status Clinical Trial Phase
Completed NCT05563701 - Evaluation of the LVivo Image Quality Scoring (IQS)
Completed NCT04908397 - Carnitine Consumption and Augmentation in Pulmonary Arterial Hypertension Phase 1
Terminated NCT03309358 - A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic Fibrosis Phase 1
Completed NCT03682354 - ESPB Versus INB With PCIA in Video-assisted Thoracic Surgery N/A
Enrolling by invitation NCT03683186 - A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension Phase 3
Completed NCT03626519 - Effects of Menthol on Dyspnoea in COPD Patients N/A
Recruiting NCT06004440 - Real World Registry for Use of the Ion Endoluminal System
Completed NCT04874948 - Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment Phase 1
Completed NCT02926768 - Phase I/II Study of CK-101 in NSCLC Patients and Other Advanced Solid Tumors Phase 1
Completed NCT01443845 - Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS) Phase 4
Completed NCT00281216 - Innate and Adaptive Immunity in Individuals Experiencing Chronic Obstructive Pulmonary Disease Exacerbations N/A
Completed NCT00269256 - Stress, Environment, and Genetics in Urban Children With Asthma N/A
Terminated NCT00233207 - IC14 Antibodies to Treat Individuals With Acute Lung Injury Phase 2
Recruiting NCT00129350 - Assessment of Heart and Heart-Lung Transplant Patient Outcomes Following Pulmonary Rehabilitation Phase 1
Active, not recruiting NCT00115297 - Montelukast for Early Life Wheezing Phase 2/Phase 3
Completed NCT00094276 - Intervention for Improving Asthma Care for Minority Children in Head Start N/A
Completed NCT00091767 - Genetic Studies in Difficult to Treat Asthma: TENOR N/A
Completed NCT00083798 - Family Linkage Study of Obstructive Sleep Apnea (OSA) in Iceland N/A
Completed NCT00089752 - Continuous Positive Airway Pressure to Improve Milder Obstructive Sleep Apnea N/A
Completed NCT00069823 - Study of Acid Reflux in Asthma Phase 3