Tobacco Smoke Pollution
Conditions
Keywords
tobacco smoke exposure smoking
Brief summary
Environmental tobacco smoke (ETS0, also known as secondhand smoke, is the combination of smoke given off by the burning end of a tobacco product and the smoke exhaled by the smoker. Children exposed to ETS are at an increased risk of sudden infant death syndrome (SIDS), ear infections, colds, pneumonia, bronchitis and more severe asthma. ETS can also slow the growth of children's lungs and can cause them to cough, wheeze and fell breathless. The purpose of this study is to determine the effectiveness of a motivational interviewing-based program in reducing ETS exposure and improving lung health among children who are enrolled in a Head Start program and whose households include a smoker.
Detailed description
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.
Interventions
BEHAVIORALMotivational Interviewing Intervention 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.
BEHAVIORALEducational Program for ETS Reduction
An Environmental Protection Agency-based educational program that will consist of information about reducing tobacco smoke exposure.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Masking description
For masking we were unable to mask the caregiver and child participant since they knew if they were receiving intervention component. The investigator was masked, but outcome assessor may have known group assignment.
Eligibility
Sex/Gender
ALL
Age
6 Months to 6 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Air Nicotine Levels | Measured at Baseline, 3, 6 and 12 months | Air nicotine levels were an indicator of child's exposure to environmental tobacco smoke (ETS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ETS Reduction, as Measured by Child's Cotinine Levels | Measured at Baseline, 3, 6 and 12 months | Child salivary cotinine will be a measure to evaluate environmental tobacco smoke (ETS) reduction |
| Respiratory Function of Child by Self Report of Parent | Measured at Baseline, 3, 6, and 12 months | Number of cold infections child experienced in previous 3 months, reported by caregiver |
| Health Care Utilization by Child- Self Report From Parent/Caregiver | 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 |
| Number of Participants Who Report Endorsing a Home Smoking Ban | Measured at baseline, 3, 6 and 12 months | Number of participants endorsing presence of home smoking ban |
Countries
United States
Participant flow
Recruitment details
Caregivers of children were recruited from 16 Baltimore City Head Start programs from April 2009 to August 2012 with final data collection ending August 2013.
Pre-assignment details
Caregivers had to complete a baseline assessment prior to randomization and reported information for themselves and the targeted child due to the young age of the child. 350 caregivers were recruited but only 330 were randomized because 20 did not complete the baseline assessment.
Participants by arm
| Arm | Count |
|---|---|
| Behavioral Motivational Interviewing Intervention Plus Education
Caregivers of children will receive a home-based motivational interviewing intervention for ETS reduction plus an educational program for ETS reduction.
Motivational Interviewing Intervention 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. | 165 |
| Education Only Caregivers will receive only educational program for ETS reduction.
Educational Program for ETS Reduction: An Environmental Protection Agency-based educational program that will consist of information about reducing tobacco smoke exposure. | 165 |
| Total | 330 |
Baseline characteristics
| Characteristic | Behavioral | Education Only | Total |
|---|---|---|---|
| Age, Continuous caregiver age | 32.07 years STANDARD_DEVIATION 8.6 | 32.12 years STANDARD_DEVIATION 9.18 | 32.09 years STANDARD_DEVIATION 8.87 |
| Age, Continuous child age | 3.81 years STANDARD_DEVIATION 0.81 | 3.71 years STANDARD_DEVIATION 0.82 | 3.76 years STANDARD_DEVIATION 0.82 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 153 Participants | 149 Participants | 302 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 7 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 9 Participants | 19 Participants |
| Region of Enrollment United States | 165 participants | 165 participants | 330 participants |
| Sex: Female, Male Caregiver Gender Female | 140 Participants | 148 Participants | 288 Participants |
| Sex: Female, Male Caregiver Gender Male | 25 Participants | 17 Participants | 42 Participants |
| Sex: Female, Male Child Gender Female | 87 Participants | 78 Participants | 165 Participants |
| Sex: Female, Male Child Gender Male | 78 Participants | 87 Participants | 165 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / 165 | 10 / 165 |
| serious Total, serious adverse events | 1 / 165 | 1 / 165 |
Outcome results
Primary
Air Nicotine Levels
Air nicotine levels were an indicator of child's exposure to environmental tobacco smoke (ETS)
Time frame: Measured at Baseline, 3, 6 and 12 months
Population: The number analyzed differs at each time point due to missing data. Reasons for missing data include unable to contact
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Behavioral | Air Nicotine Levels | Baseline | 1.17 mg/m^3 |
| Behavioral | Air Nicotine Levels | 3 month | 0.71 mg/m^3 |
| Behavioral | Air Nicotine Levels | 6 month | 0.75 mg/m^3 |
| Behavioral | Air Nicotine Levels | 12 month | 0.55 mg/m^3 |
| Education Only | Air Nicotine Levels | 12 month | 0.32 mg/m^3 |
| Education Only | Air Nicotine Levels | Baseline | 0.58 mg/m^3 |
| Education Only | Air Nicotine Levels | 6 month | 0.52 mg/m^3 |
| Education Only | Air Nicotine Levels | 3 month | 0.51 mg/m^3 |
Secondary
ETS Reduction, as Measured by Child's Cotinine Levels
Child salivary cotinine will be a measure to evaluate environmental tobacco smoke (ETS) reduction
Time frame: Measured at Baseline, 3, 6 and 12 months
Population: The number analyzed differs at each time point due to missing data. Reasons for missing include unable to contact, samples not able to be analyzed due to insufficient quantity of saliva collected, or child not available during assessment.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Behavioral | ETS Reduction, as Measured by Child's Cotinine Levels | Baseline | 4.14 ng/mL |
| Behavioral | ETS Reduction, as Measured by Child's Cotinine Levels | 3 Months | 4.14 ng/mL |
| Behavioral | ETS Reduction, as Measured by Child's Cotinine Levels | 6 Months | 3.60 ng/mL |
| Behavioral | ETS Reduction, as Measured by Child's Cotinine Levels | 12 Months | 4.04 ng/mL |
| Education Only | ETS Reduction, as Measured by Child's Cotinine Levels | 12 Months | 2.83 ng/mL |
| Education Only | ETS Reduction, as Measured by Child's Cotinine Levels | Baseline | 3.00 ng/mL |
| Education Only | ETS Reduction, as Measured by Child's Cotinine Levels | 6 Months | 3.04 ng/mL |
| Education Only | ETS Reduction, as Measured by Child's Cotinine Levels | 3 Months | 3.25 ng/mL |
Secondary
Health Care Utilization by Child- Self Report From Parent/Caregiver
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
Time frame: Measured at baseline and 3, 6 and 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Behavioral | Health Care Utilization by Child- Self Report From Parent/Caregiver | BL Urgent Care Visits | 80 Participants |
| Behavioral | Health Care Utilization by Child- Self Report From Parent/Caregiver | 3M Urgent Care Visits | 18 Participants |
| Behavioral | Health Care Utilization by Child- Self Report From Parent/Caregiver | 6M Urgent Care Visits | 14 Participants |
| Behavioral | Health Care Utilization by Child- Self Report From Parent/Caregiver | 12M Urgent Care Visits | 13 Participants |
| Behavioral | Health Care Utilization by Child- Self Report From Parent/Caregiver | BL Hospitalizations | 10 Participants |
| Behavioral | Health Care Utilization by Child- Self Report From Parent/Caregiver | 3M Hospitalizations | 4 Participants |
| Behavioral | Health Care Utilization by Child- Self Report From Parent/Caregiver | 6M Hospitalizations | 1 Participants |
| Behavioral | Health Care Utilization by Child- Self Report From Parent/Caregiver | 12M Hospitalizations | 1 Participants |
| Behavioral | Health Care Utilization by Child- Self Report From Parent/Caregiver | BL Emergency Dept Visit | 75 Participants |
| Behavioral | Health Care Utilization by Child- Self Report From Parent/Caregiver | 3M Emergency Dept Visit | 18 Participants |
| Behavioral | Health Care Utilization by Child- Self Report From Parent/Caregiver | 6M Emergency Dept Visit | 13 Participants |
| Behavioral | Health Care Utilization by Child- Self Report From Parent/Caregiver | 12M Emergency Dept Visit | 9 Participants |
| Education Only | Health Care Utilization by Child- Self Report From Parent/Caregiver | 6M Emergency Dept Visit | 13 Participants |
| Education Only | Health Care Utilization by Child- Self Report From Parent/Caregiver | BL Urgent Care Visits | 73 Participants |
| Education Only | Health Care Utilization by Child- Self Report From Parent/Caregiver | 6M Hospitalizations | 2 Participants |
| Education Only | Health Care Utilization by Child- Self Report From Parent/Caregiver | 3M Urgent Care Visits | 15 Participants |
| Education Only | Health Care Utilization by Child- Self Report From Parent/Caregiver | 3M Emergency Dept Visit | 13 Participants |
| Education Only | Health Care Utilization by Child- Self Report From Parent/Caregiver | 6M Urgent Care Visits | 19 Participants |
| Education Only | Health Care Utilization by Child- Self Report From Parent/Caregiver | 12M Hospitalizations | 2 Participants |
| Education Only | Health Care Utilization by Child- Self Report From Parent/Caregiver | 12M Urgent Care Visits | 14 Participants |
| Education Only | Health Care Utilization by Child- Self Report From Parent/Caregiver | 12M Emergency Dept Visit | 14 Participants |
| Education Only | Health Care Utilization by Child- Self Report From Parent/Caregiver | BL Hospitalizations | 14 Participants |
| Education Only | Health Care Utilization by Child- Self Report From Parent/Caregiver | BL Emergency Dept Visit | 74 Participants |
| Education Only | Health Care Utilization by Child- Self Report From Parent/Caregiver | 3M Hospitalizations | 3 Participants |
Secondary
Number of Participants Who Report Endorsing a Home Smoking Ban
Number of participants endorsing presence of home smoking ban
Time frame: Measured at baseline, 3, 6 and 12 months
Population: The number analyzed differs at each time point due to missing data. Reasons for missing data include unable to contact
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Behavioral | Number of Participants Who Report Endorsing a Home Smoking Ban | BL | 129 Participants |
| Behavioral | Number of Participants Who Report Endorsing a Home Smoking Ban | 6M | 78 Participants |
| Behavioral | Number of Participants Who Report Endorsing a Home Smoking Ban | 3M | 80 Participants |
| Behavioral | Number of Participants Who Report Endorsing a Home Smoking Ban | 12M | 65 Participants |
| Education Only | Number of Participants Who Report Endorsing a Home Smoking Ban | 12M | 82 Participants |
| Education Only | Number of Participants Who Report Endorsing a Home Smoking Ban | BL | 118 Participants |
| Education Only | Number of Participants Who Report Endorsing a Home Smoking Ban | 3M | 89 Participants |
| Education Only | Number of Participants Who Report Endorsing a Home Smoking Ban | 6M | 83 Participants |
Secondary
Respiratory Function of Child by Self Report of Parent
Number of cold infections child experienced in previous 3 months, reported by caregiver
Time frame: Measured at Baseline, 3, 6, and 12 months
Population: The number analyzed differs at each time point due to missing data. Reasons for missing include unable to contact or caregiver refused or did not fully complete survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Behavioral | Respiratory Function of Child by Self Report of Parent | 6 Months | 0.38 cold infections | Standard Deviation 0.65 |
| Behavioral | Respiratory Function of Child by Self Report of Parent | Baseline | 1.07 cold infections | Standard Deviation 1.06 |
| Behavioral | Respiratory Function of Child by Self Report of Parent | 12 Months | 0.32 cold infections | Standard Deviation 0.77 |
| Behavioral | Respiratory Function of Child by Self Report of Parent | 3 Months | 0.44 cold infections | Standard Deviation 0.56 |
| Education Only | Respiratory Function of Child by Self Report of Parent | 12 Months | 0.33 cold infections | Standard Deviation 0.51 |
| Education Only | Respiratory Function of Child by Self Report of Parent | 6 Months | 0.36 cold infections | Standard Deviation 0.52 |
| Education Only | Respiratory Function of Child by Self Report of Parent | Baseline | 1 cold infections | Standard Deviation 1 |
| Education Only | Respiratory Function of Child by Self Report of Parent | 3 Months | 0.54 cold infections | Standard Deviation 0.88 |