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Lung DiseasesNCT00005396

Motivating Smokers--Reduce Child Environmental Tobacco Smoke Exposure

An observational study of Lung Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages Up to 100 years, men only
Conditions the study is for
Lung Diseases
How many people
Not given
Where
No sites listed yet
Study dates
Sep 1994to Aug 1999
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 100 years
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

No eligibility criteria

About this study

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.

Read the detailed 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.

Conditions
Lung Diseases
Medical subject headings
Lung Diseases

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2000 (estimated)
  2. Study startSep 1994
  3. Study completionAug 1999

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005396
Sponsor's protocol ID
4304
Other IDs
R01HL054351
Status last verified
Apr 2002
First submitted
25 May 2000
Last updated
18 Feb 2016
Results posted
No

Publications

  • 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. doi: 10.1542/peds.108.1.18.

    PubMed 11433049

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00005396, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2016.

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