AIM to Improve Asthma: Airflow Improvements During Meal-Prep (AIM)
Primary Purpose
Asthma in Children, Pollution; Exposure
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cooking Ventilation Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Asthma in Children focused on measuring asthma, pediatric, indoor air pollution, particulate matter, nitrogen dioxide, cooking, ventilation
Eligibility Criteria
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.
Sites / Locations
- University of California BerkeleyRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Intervention after One Week
Arm Description
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.
Outcomes
Primary Outcome Measures
Continuously-Measured Home PM2.5 (Fine Particulate Matter) Levels Prior to Intervention
Home PM2.5 levels will measured in real-time using the Clarity air sensors.
Continuously-Measured Home PM2.5 (Fine Particulate Matter) Levels Following Intervention
Home PM2.5 levels will measured in real-time using the Clarity air sensors.
Continuously-Measured Home NO2 (Nitrogen Dioxide) Levels Prior to Intervention
Home NO2 levels will measured in real-time using the Clarity air sensors.
Continuously-Measured Home NO2 (Nitrogen Dioxide) Level Following Intervention
Home NO2 levels will measured in real-time using the Clarity air sensors.
Secondary Outcome Measures
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.
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.
Spirometry- Forced Expiratory Flow (FEF)
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 flow measures the flow rate at different volumes of the forced exhalation maneuver.
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.
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.
Spirometry- Forced Expiratory Flow (FEF)
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 flow measures the flow rate at different volumes of the forced exhalation maneuver.
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.
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.
Spirometry- Forced Expiratory Flow (FEF)
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 flow measures the flow rate at different volumes of the forced exhalation maneuver.
Fractional Exhaled Nitric Oxide (FeNO)
FeNO s a non-invasive measure of airways inflammation. FeNO will be performed using a NIOX Vero device; staff will be trained thoroughly in administration of the test.
Fractional Exhaled Nitric Oxide (FeNO)
FeNO s a non-invasive measure of airways inflammation. FeNO will be performed using a NIOX Vero device; staff will be trained thoroughly in administration of the test.
Fractional Exhaled Nitric Oxide (FeNO)
FeNO s a non-invasive measure of airways inflammation. FeNO will be performed using a NIOX Vero device; staff will be trained thoroughly in administration of the test.
Asthma Control
Asthma control will be assessed using the widely-accepted, validated Asthma Control Test for children with asthma.
Asthma Control
Asthma control will be assessed using the widely-accepted, validated Asthma Control Test for children with asthma.
Asthma Control
Asthma control will be assessed using the widely-accepted, validated Asthma Control Test for children with asthma.
Full Information
NCT ID
NCT04464720
First Posted
December 18, 2019
Last Updated
November 9, 2021
Sponsor
University of California, Berkeley
Collaborators
National Institute of Environmental Health Sciences (NIEHS)
1. Study Identification
Unique Protocol Identification Number
NCT04464720
Brief Title
AIM to Improve Asthma: Airflow Improvements During Meal-Prep
Acronym
AIM
Official Title
AIM to Improve Asthma: Airflow Improvements During Meal-Prep
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 24, 2021 (Actual)
Primary Completion Date
August 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Berkeley
Collaborators
National Institute of Environmental Health Sciences (NIEHS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma in Children, Pollution; Exposure
Keywords
asthma, pediatric, indoor air pollution, particulate matter, nitrogen dioxide, cooking, ventilation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a trial with a single group, where they receive the intervention following one week of baseline data collection.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention after One Week
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cooking Ventilation Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Continuously-Measured Home PM2.5 (Fine Particulate Matter) Levels Prior to Intervention
Description
Home PM2.5 levels will measured in real-time using the Clarity air sensors.
Time Frame
1 week in the 'Intervention after 1 week group' and 2 weeks in the 'Intervention after 2 weeks' group
Title
Continuously-Measured Home PM2.5 (Fine Particulate Matter) Levels Following Intervention
Description
Home PM2.5 levels will measured in real-time using the Clarity air sensors.
Time Frame
2 weeks in the 'Intervention after 1 week group' and 1 week in the 'Intervention after 2 weeks' group
Title
Continuously-Measured Home NO2 (Nitrogen Dioxide) Levels Prior to Intervention
Description
Home NO2 levels will measured in real-time using the Clarity air sensors.
Time Frame
1 week in the 'Intervention after 1 week group' and 2 weeks in the 'Intervention after 2 weeks' group
Title
Continuously-Measured Home NO2 (Nitrogen Dioxide) Level Following Intervention
Description
Home NO2 levels will measured in real-time using the Clarity air sensors.
Time Frame
2 weeks in the 'Intervention after 1 week group' and 1 week in the 'Intervention after 2 weeks' group
Secondary Outcome Measure Information:
Title
Spirometry- Forced Vital Capacity (FVC)
Description
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.
Time Frame
measured at the second home visit, after one week of the study
Title
Spirometry- Forced Expiratory Volume in One Second (FEV1)
Description
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.
Time Frame
measured at the second home visit, after one week of the study
Title
Spirometry- Forced Expiratory Flow (FEF)
Description
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 flow measures the flow rate at different volumes of the forced exhalation maneuver.
Time Frame
measured at the second home visit, after one week of the study
Title
Spirometry-Forced Vital Capacity (FVC)
Description
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.
Time Frame
measured at the third home visit, after two weeks of the study
Title
Spirometry- Forced Expiratory Volume in One Second (FEV1)
Description
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.
Time Frame
measured at the third home visit, after two weeks of the study
Title
Spirometry- Forced Expiratory Flow (FEF)
Description
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 flow measures the flow rate at different volumes of the forced exhalation maneuver.
Time Frame
measured at the third home visit, after two weeks of the study
Title
Spirometry-Forced Vital Capacity (FVC)
Description
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.
Time Frame
measured at the fourth home visit, after three weeks of the study
Title
Spirometry- Forced Expiratory Volume in One Second (FEV1)
Description
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.
Time Frame
measured at the fourth home visit, after three weeks of the study
Title
Spirometry- Forced Expiratory Flow (FEF)
Description
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 flow measures the flow rate at different volumes of the forced exhalation maneuver.
Time Frame
measured at the fourth home visit, after three weeks of the study
Title
Fractional Exhaled Nitric Oxide (FeNO)
Description
FeNO s a non-invasive measure of airways inflammation. FeNO will be performed using a NIOX Vero device; staff will be trained thoroughly in administration of the test.
Time Frame
measured at the second home visit, after one week of the study
Title
Fractional Exhaled Nitric Oxide (FeNO)
Description
FeNO s a non-invasive measure of airways inflammation. FeNO will be performed using a NIOX Vero device; staff will be trained thoroughly in administration of the test.
Time Frame
measured at the third home visit, after two weeks of the study
Title
Fractional Exhaled Nitric Oxide (FeNO)
Description
FeNO s a non-invasive measure of airways inflammation. FeNO will be performed using a NIOX Vero device; staff will be trained thoroughly in administration of the test.
Time Frame
measured at the fourth home visit, after three weeks of the study
Title
Asthma Control
Description
Asthma control will be assessed using the widely-accepted, validated Asthma Control Test for children with asthma.
Time Frame
measured at the second home visit, after one week of the study
Title
Asthma Control
Description
Asthma control will be assessed using the widely-accepted, validated Asthma Control Test for children with asthma.
Time Frame
measured at the third home visit, after two weeks of the study
Title
Asthma Control
Description
Asthma control will be assessed using the widely-accepted, validated Asthma Control Test for children with asthma.
Time Frame
measured at the fourth home visit, after three weeks of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Holm, MD PhD MPH
Phone
(510) 621-3250
Email
RichmondAIMstudy@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John R Balmes, MD
Organizational Affiliation
University of California, Berkeley
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Berkeley
City
Berkeley
State/Province
California
ZIP/Postal Code
94720
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie M Holm, MD MPH
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Learn more about this trial
AIM to Improve Asthma: Airflow Improvements During Meal-Prep
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