Asthma in Children, Pollution; Exposure
Conditions
Keywords
asthma, pediatric, indoor air pollution, particulate matter, nitrogen dioxide, cooking, ventilation
Brief summary
The investigators propose a pilot trial of kitchen ventilation in the homes of children using a youth engaged research strategy.
Detailed description
In this trial of children ages 6-12, children and their households will receive an intensive home kitchen ventilation intervention after one week of baseline data collection. The intervention includes education regarding improving ventilation in their homes during cooking and replacement of their range hood if it has inadequate flow or an intolerable noise level. During baseline data collection periods the households will be encouraged to continue their regular cooking patterns. The investigators will measure home particulate matter \<2.5 microns (PM2.5) and nitrogen dioxide (NO2) levels for one week at baseline, and a final week after all remaining families receive the cooking ventilation intervention, to assess for changes within each household. The investigators will also examine changes in airways inflammation (as measured by the exhaled fraction of nitric oxide, FeNO), lung function (as measured by spirometry), and reported symptoms after the baseline and intervention period. Members of the research team have successfully conducted youth participatory action research in the low-income, high asthma prevalence community of Richmond, California (CA) as well as extensive youth participatory action research on other environmental health concerns in the low income city of Salinas, CA; using a similar model, the investigators aim to teach research methods to a new group of Richmond youth.
Interventions
BEHAVIORALCooking Ventilation Intervention
An educational video presentation for the families regarding the importance of ventilation use during and after cooking, and strategies for improving the ventilation during cooking, has been created by Dr. Holm, with input from Youth Research Assistants (YRAs) The youth involvement will help to ensure that the information is presented in a way that will resonate with the local community and will also provide the youth with exposure to developing health education tools. The educational video will be shown to families at the time of the intervention visit and they will receive printed reminder materials of what they have learned.
Sponsors
National Institute of Environmental Health Sciences (NIEHS)
University of California, Berkeley
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This is a trial with a single group, where they receive the intervention following one week of baseline data collection.
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Household has a gas stove * Household has a range hood that vents to the outdoors * Household in Richmond or San Pablo
Exclusion criteria
* Child has other significant medical illnesses (e.g. prematurity, diabetes) * living with a smoker who smokes indoors * family knows they will not have stable housing for the period of the study * Parent is not fluent in English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Continuously-Measured Home NO2 (Nitrogen Dioxide) Level Following Intervention | 1-2 weeks | Home NO2 levels were measured with eLichens sensors |
| Continuously-Measured Home PM2.5 (Fine Particulate Matter) Levels Following Intervention | 1-2 weeks | Home PM2.5 levels were measured in real-time using the eLichens sensors |
| Continuously-Measured Home NO2 (Nitrogen Dioxide) Levels Prior to Intervention | 1-2 weeks | Home NO2 levels were measured in real-time using eLichens sensors |
| Continuously-Measured Home PM2.5 (Fine Particulate Matter) Levels Prior to Intervention | 1-2 weeks | Home PM2.5 levels were measured in real-time with eLichens sensors. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spirometry- Forced Vital Capacity (FVC) | measured at the end of the pre-intervention interval | Spirometry is a non-invasive measure of lung function. Spirometry will be performed using an Easy One Air Spirometer; staff will be trained thoroughly in administration of the test. Forced Vital Capacity measures the total volume of air that a person can breathe out forcefully from a full breath, blowing all of it out. Z-Scores were created using global lung initiative normative data. A Z-score of 0 represents the population mean for a participant of that age, sex and height. A decrease in Z scores suggests worsened lung function over time. |
| Asthma Control | measured at the end of the pre-intervention interval | Asthma control was assessed using the widely-accepted, validated Childhood Asthma Control Test (cACT) for children with asthma. The cACT scale ranges from 0 to 27. Values up to 15 represent very poorly controlled asthma, 16-20 represents poorly controlled asthma and 21 or greater is considered well-controlled asthma. |
| Spirometry- Forced Expiratory Volume in One Second (FEV1) | measured at the end of the pre-intervention interval | Spirometry is a non-invasive measure of lung function. Spirometry will be performed using an Easy One Air Spirometer; staff will be trained thoroughly in administration of the test. Forced expiratory volume in one second measures the volume of air that a person breathes out forcefully in the first second of blowing out a full breath. Z-Scores were created using global lung initiative normative data. A Z-score of 0 represents the population mean for a participant of that age, sex and height. A decrease in Z scores suggests worsened lung function over time. |
| Spirometry-Forced Vital Capacity (FVC) | measured at the end of the post-intervention interval | Spirometry is a non-invasive measure of lung function. Spirometry was be performed using an Easy One Air Spirometer. Forced Vital Capacity measures the total volume of air that a person can breathe out forcefully from a full breath, blowing all of it out. Z-Scores were created using global lung initiative normative data. A Z-score of 0 represents the population mean for a participant of that age, sex and height. A decrease in Z scores suggests worsened lung function over time. |
| Fractional Exhaled Nitric Oxide (FeNO) | measured at the end of the pre-intervention interval | FeNO s a non-invasive measure of airways inflammation. FeNO was performed using a NIOX Vero device. |
Countries
United States
Participant flow
Recruitment details
Recruitment primarily occurred through East Bay pediatric clinics via recruitment fliers and information cards. At a few clinics, postcard mailings were also sent to potentially eligible patients. We also advertised for the study on an institutional website, through social media, and via fliers at community spaces (libraries, community centers, etc).
Pre-assignment details
Due to low enrollment during the study period (height of the COVID-19 pandemic), the study shifted to a before-after trial so no group assignments were performed.
Participants by arm
| Arm | Count |
|---|---|
| Intervention After 1-2 Weeks Baseline data on air pollutant levels, stove use and range hood use were collected for one week prior to receiving an educational intervention aimed at increasing use of the range hood. Data following the intervention will be collected for an additional 1-2 weeks.
Cooking Ventilation Intervention: An educational video presentation for the families regarding the importance of ventilation use during and after cooking, and strategies for improving the ventilation during cooking, was been created by Dr. Holm, with input from Youth Research Assistants (YRAs). The youth involvement helped to ensure that the information was presented in a way that will resonate with the local community. The educational video was shown to families at the time of the intervention visit and they will receive printed reminder materials of what they have learned. | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Pre-Intervention | Intervention (hood retrofit) beyond the scope available in the study, so participation ended. | 1 |
Baseline characteristics
| Characteristic | Intervention After 1-2 Weeks |
|---|---|
| Age, Continuous | 8 years |
| Asthma Diagnosis Ever diagnosed with asthma | 7 Participants |
| Asthma Diagnosis Never diagnosed with asthma | 16 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Region of Enrollment United States | 23 participants |
| Sex/Gender, Customized Sex female | 13 Participants |
| Sex/Gender, Customized Sex intersex | 0 Participants |
| Sex/Gender, Customized Sex male | 10 Participants |
| Sex/Gender, Customized Sex other | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 19 |
| other Total, other adverse events | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
Primary
Continuously-Measured Home NO2 (Nitrogen Dioxide) Level Following Intervention
Home NO2 levels were measured with eLichens sensors
Time frame: 1-2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention After 1-2 Weeks | Continuously-Measured Home NO2 (Nitrogen Dioxide) Level Following Intervention | 15900 ppb*min |
Comparison: comparing pre v post intervention NO2p-value: 0.043Wilcoxon Ranked Sum
Primary
Continuously-Measured Home NO2 (Nitrogen Dioxide) Levels Prior to Intervention
Home NO2 levels were measured in real-time using eLichens sensors
Time frame: 1-2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention After 1-2 Weeks | Continuously-Measured Home NO2 (Nitrogen Dioxide) Levels Prior to Intervention | 50600 ppb*min |
Primary
Continuously-Measured Home PM2.5 (Fine Particulate Matter) Levels Following Intervention
Home PM2.5 levels were measured in real-time using the eLichens sensors
Time frame: 1-2 weeks
Population: 1 participant did not continue to the post-intervention interval because intervening on their home's range hood would have required resources outside the scope of the project.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention After 1-2 Weeks | Continuously-Measured Home PM2.5 (Fine Particulate Matter) Levels Following Intervention | 4570 (mcg/m3)*min |
Primary
Continuously-Measured Home PM2.5 (Fine Particulate Matter) Levels Prior to Intervention
Home PM2.5 levels were measured in real-time with eLichens sensors.
Time frame: 1-2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention After 1-2 Weeks | Continuously-Measured Home PM2.5 (Fine Particulate Matter) Levels Prior to Intervention | 10200 (mcg/m3)*min |
Comparison: comparing pre and post intervention PM2.5p-value: 0.05Wilcoxon Ranked Sum
Secondary
Asthma Control
Asthma control was assessed using the widely-accepted, validated Childhood Asthma Control Test (cACT) for children with asthma. The cACT scale ranges from 0 to 27. Values up to 15 represent very poorly controlled asthma, 16-20 represents poorly controlled asthma and 21 or greater is considered well-controlled asthma.
Time frame: measured at the end of the post-intervention interval
Population: Assessed only in those with asthma. 3/4 participants completed this survey in the post-interval.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention After 1-2 Weeks | Asthma Control | 26 score on a scale |
Secondary
Asthma Control
Asthma control was assessed using the widely-accepted, validated Childhood Asthma Control Test (cACT) for children with asthma. The cACT scale ranges from 0 to 27. Values up to 15 represent very poorly controlled asthma, 16-20 represents poorly controlled asthma and 21 or greater is considered well-controlled asthma.
Time frame: measured at the end of the pre-intervention interval
Population: assessed only among those with asthma, and 4/4 completed the survey in this interval
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention After 1-2 Weeks | Asthma Control | 25 score on a scale |
Secondary
Fractional Exhaled Nitric Oxide (FeNO)
FeNO s a non-invasive measure of airways inflammation. FeNO was performed using a NIOX Vero device.
Time frame: measured at the end of the pre-intervention interval
Population: This is again a cognitively tricky maneuver to execute, so these 9 children are those that were able to complete FeNO.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention After 1-2 Weeks | Fractional Exhaled Nitric Oxide (FeNO) | 19.7 ppb |
Secondary
Fractional Exhaled Nitric Oxide (FeNO)
FeNO is a non-invasive measure of airways inflammation. FeNO will be performed using a NIOX Vero device.
Time frame: measured at the end of the post-intervention interval
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention After 1-2 Weeks | Fractional Exhaled Nitric Oxide (FeNO) | 22.5 ppb |
Comparison: comparing FeNO pre v post interventionp-value: 0.058Wilcoxon Ranked Sum
Secondary
Spirometry- Forced Expiratory Volume in One Second (FEV1)
Spirometry is a non-invasive measure of lung function. Spirometry was performed using an Easy One Air Spirometer. Forced expiratory volume in one second measures the volume of air that a person breathes out forcefully in the first second of blowing out a full breath. Z-Scores were created using global lung initiative normative data. A Z-score of 0 represents the population mean for a participant of that age, sex and height. A decrease in Z scores suggests worsened lung function over time.
Time frame: measured at the end of the post-intervention interval
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention After 1-2 Weeks | Spirometry- Forced Expiratory Volume in One Second (FEV1) | -0.5 Z-score |
Comparison: Comparing FEV1 pre and post interventionp-value: 0.058Wilcoxon Signed Rank
Secondary
Spirometry- Forced Expiratory Volume in One Second (FEV1)
Spirometry is a non-invasive measure of lung function. Spirometry will be performed using an Easy One Air Spirometer; staff will be trained thoroughly in administration of the test. Forced expiratory volume in one second measures the volume of air that a person breathes out forcefully in the first second of blowing out a full breath. Z-Scores were created using global lung initiative normative data. A Z-score of 0 represents the population mean for a participant of that age, sex and height. A decrease in Z scores suggests worsened lung function over time.
Time frame: measured at the end of the pre-intervention interval
Population: these are the data for the 11 children who were able to successfully complete the spirometry maneuver, which can be conceptually challenging, especially for young children.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention After 1-2 Weeks | Spirometry- Forced Expiratory Volume in One Second (FEV1) | 0.5 Z-score |
Secondary
Spirometry- Forced Vital Capacity (FVC)
Spirometry is a non-invasive measure of lung function. Spirometry will be performed using an Easy One Air Spirometer; staff will be trained thoroughly in administration of the test. Forced Vital Capacity measures the total volume of air that a person can breathe out forcefully from a full breath, blowing all of it out. Z-Scores were created using global lung initiative normative data. A Z-score of 0 represents the population mean for a participant of that age, sex and height. A decrease in Z scores suggests worsened lung function over time.
Time frame: measured at the end of the pre-intervention interval
Population: spirometry can be technically challenging, especially for younger children, and thus we only have results for a subset of the participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention After 1-2 Weeks | Spirometry- Forced Vital Capacity (FVC) | 0.7 Z-score |
Secondary
Spirometry-Forced Vital Capacity (FVC)
Spirometry is a non-invasive measure of lung function. Spirometry was be performed using an Easy One Air Spirometer. Forced Vital Capacity measures the total volume of air that a person can breathe out forcefully from a full breath, blowing all of it out. Z-Scores were created using global lung initiative normative data. A Z-score of 0 represents the population mean for a participant of that age, sex and height. A decrease in Z scores suggests worsened lung function over time.
Time frame: measured at the end of the post-intervention interval
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention After 1-2 Weeks | Spirometry-Forced Vital Capacity (FVC) | -0.3 Z-score |
Comparison: comparing FVC pre and post interventionp-value: 0.056Wilcoxon Ranked Sum