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| ID | Type | Description | Link |
|---|---|---|---|
| R21ES030173 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Environmental Health Sciences (NIEHS) | NIH |
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The investigators propose a pilot trial of kitchen ventilation in the homes of children using a youth engaged research strategy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention after One Week | Other | This arm will have baseline data on air pollutant levels, stove use and range hood use 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 week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cooking Ventilation Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Continuously-Measured Home PM2.5 (Fine Particulate Matter) Levels Prior to Intervention | Home PM2.5 levels were measured in real-time with eLichens sensors. | 1-2 weeks |
| Continuously-Measured Home PM2.5 (Fine Particulate Matter) Levels Following Intervention | Home PM2.5 levels were measured in real-time using the eLichens sensors | 1-2 weeks |
| Continuously-Measured Home NO2 (Nitrogen Dioxide) Levels Prior to Intervention | Home NO2 levels were measured in real-time using eLichens sensors | 1-2 weeks |
| Continuously-Measured Home NO2 (Nitrogen Dioxide) Level Following Intervention | Home NO2 levels were measured with eLichens sensors | 1-2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John R Balmes, MD | University of California, Berkeley | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Berkeley | Berkeley | California | 94720 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39521897 | Derived | Holm SM, Singer BC, Kang Dufour MS, Delp W, Nolan JES, Bueno de Mesquita PJ, Ward B, Williamson Y, Le O, Russell ML, Harley KG, Balmes JR. Measured air quality impacts after teaching parents about cooking ventilation with a video: a pilot study. J Expo Sci Environ Epidemiol. 2025 Apr;35(2):223-232. doi: 10.1038/s41370-024-00730-6. Epub 2024 Nov 9. |
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There is no current plan to share data but the investigators would be willing to entertain requests from other researchers for sharing of de-identified data only. Subjects will be asked to give permission for release of photographs of them for future presentations and other outreach materials.
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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.
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention After 1-2 Weeks | This arm will have baseline data on air pollutant levels, stove use and range hood use 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 week. 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, 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-Intervention |
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| Post-Intervention |
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Though 23 participants screened in for the study and consented to collection of screening data, 3 participants were unable to get initial visits scheduled in time to complete the study prior to the loss of study staff. 1 participant we stopped being able to reach. Thus, 19 were consented for the full study and began baseline.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Inter-Quartile Range | (mcg/m3)*min | 1-2 weeks |
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We monitored for Adverse Events from enrollment and through the over the full period of data collection which ranged from 12 to 54 days among different participants (based on changing protocols during the pandemic).
No adverse events occured.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention After 1-2 Weeks | This arm had baseline data on air pollutant levels, stove use and range hood use collected for one week prior to receiving an educational intervention aimed at increasing use of the range hood. Data following the intervention were collected for an additional 1-2 weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stephanie M Holm | University of California San Francisco | 415-514-0878 | stephanie.holm@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 1, 2022 | Jun 3, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 12, 2024 | Jun 3, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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This is a trial with a single group, where they receive the intervention following one week of baseline data collection.
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| measured at the end of the pre-intervention interval |
| 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. | measured at the end of the pre-intervention interval |
| 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. | measured at the end of the post-intervention interval |
| 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. | measured at the end of the post-intervention interval |
| Fractional Exhaled Nitric Oxide (FeNO) | FeNO s a non-invasive measure of airways inflammation. FeNO was performed using a NIOX Vero device. | measured at the end of the pre-intervention interval |
| Fractional Exhaled Nitric Oxide (FeNO) | FeNO is a non-invasive measure of airways inflammation. FeNO will be performed using a NIOX Vero device. | measured at the end of the post-intervention interval |
| 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. | measured at the end of the pre-intervention interval |
| 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. | measured at the end of the post-intervention interval |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Asthma Diagnosis | Count of Participants | Participants |
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| 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 | 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. | Posted | Median | Inter-Quartile Range | (mcg/m3)*min | 1-2 weeks |
|
|
|
| Primary | Continuously-Measured Home NO2 (Nitrogen Dioxide) Levels Prior to Intervention | Home NO2 levels were measured in real-time using eLichens sensors | Posted | Median | Inter-Quartile Range | ppb*min | 1-2 weeks |
|
|
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| Primary | Continuously-Measured Home NO2 (Nitrogen Dioxide) Level Following Intervention | Home NO2 levels were measured with eLichens sensors | Posted | Median | Inter-Quartile Range | ppb*min | 1-2 weeks |
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| 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. | spirometry can be technically challenging, especially for younger children, and thus we only have results for a subset of the participants. | Posted | Median | Full Range | Z-score | measured at the end of the pre-intervention interval |
|
|
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| 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. | 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. | Posted | Median | Full Range | Z-score | measured at the end of the pre-intervention interval |
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| 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. | Posted | Median | Full Range | Z-score | measured at the end of the post-intervention interval |
|
|
|
|
| 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. | Posted | Median | Full Range | Z-score | measured at the end of the post-intervention interval |
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| Secondary | Fractional Exhaled Nitric Oxide (FeNO) | FeNO s a non-invasive measure of airways inflammation. FeNO was performed using a NIOX Vero device. | This is again a cognitively tricky maneuver to execute, so these 9 children are those that were able to complete FeNO. | Posted | Median | Full Range | ppb | measured at the end of the pre-intervention interval |
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| Secondary | Fractional Exhaled Nitric Oxide (FeNO) | FeNO is a non-invasive measure of airways inflammation. FeNO will be performed using a NIOX Vero device. | Posted | Median | Full Range | ppb | measured at the end of the post-intervention interval |
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| 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. | assessed only among those with asthma, and 4/4 completed the survey in this interval | Posted | Median | Full Range | score on a scale | measured at the end of the pre-intervention interval |
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| 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. | Assessed only in those with asthma. 3/4 participants completed this survey in the post-interval. | Posted | Median | Full Range | score on a scale | measured at the end of the post-intervention interval |
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| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012120 | Respiration Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |