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).
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.
- First posted26 May 2000 (estimated)
- Study startSep 1994
- Study completionAug 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivating Smokers--Reduce Child Environmental Tobacco Smoke Exposure
- ClinicalTrials.gov ID
- NCT00005396
- Acronym / sponsor ID
- 4304
- Conditions
- Lung Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1994
- Study completion
- Aug 1999 (actual)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
- Background: PubMed 11433049Emmons 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.