AIM to Improve Asthma: Airflow Improvements During Meal-Prep

Asthma in Children Clinical Trial

— AIM  

Official title:

AIM to Improve Asthma: Airflow Improvements During Meal-Prep

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04464720
• Other study ID #: 2018-01-10615
• Secondary ID: R21ES030173
• Status: Completed
• Phase: N/A
• Start date: May 24, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: February 2024
• Source: University of California, Berkeley
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators propose a pilot trial of kitchen ventilation in the homes of children using a youth engaged research strategy.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Asthma in Children
• Pollution; Exposure

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of California Berkeley	Berkeley	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Berkeley	National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 week in the 'Intervention after 1 week group' and 2 weeks in the 'Intervention after 2 weeks' group
Primary	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.	2 weeks in the 'Intervention after 1 week group' and 1 week in the 'Intervention after 2 weeks' group
Primary	Continuously-Measured Home NO2 (Nitrogen Dioxide) Levels Prior to Intervention	Home NO2 levels will measured in real-time using the Clarity air sensors.	1 week in the 'Intervention after 1 week group' and 2 weeks in the 'Intervention after 2 weeks' group
Primary	Continuously-Measured Home NO2 (Nitrogen Dioxide) Level Following Intervention	Home NO2 levels will measured in real-time using the Clarity air sensors.	2 weeks in the 'Intervention after 1 week group' and 1 week in the 'Intervention after 2 weeks' group
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.	measured at the second home visit, after one week of the study
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.	measured at the second home visit, after one week of the study
Secondary	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.	measured at the second home visit, after one week of the study
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.	measured at the third home visit, after two weeks of the study
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.	measured at the third home visit, after two weeks of the study
Secondary	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.	measured at the third home visit, after two weeks of the study
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.	measured at the fourth home visit, after three weeks of the study
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.	measured at the fourth home visit, after three weeks of the study
Secondary	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.	measured at the fourth home visit, after three weeks of the study
Secondary	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.	measured at the second home visit, after one week of the study
Secondary	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.	measured at the third home visit, after two weeks of the study
Secondary	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.	measured at the fourth home visit, after three weeks of the study
Secondary	Asthma Control	Asthma control will be assessed using the widely-accepted, validated Asthma Control Test for children with asthma.	measured at the second home visit, after one week of the study
Secondary	Asthma Control	Asthma control will be assessed using the widely-accepted, validated Asthma Control Test for children with asthma.	measured at the third home visit, after two weeks of the study
Secondary	Asthma Control	Asthma control will be assessed using the widely-accepted, validated Asthma Control Test for children with asthma.	measured at the fourth home visit, after three weeks of the study