AIM to Improve Asthma: Airflow Improvements During Meal-Prep (AIM)

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

Study Overview

• Status: Completed
• Conditions: Asthma in Children; Pollution; Exposure
• Intervention / Treatment: Behavioral: Cooking Ventilation Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephanie Holm, MD PhD MPH; Phone Number: (510) 621-3250; Email: RichmondAIMstudy@gmail.com

Study Locations

• United States
  • California
    • Berkeley, California, United States, 94720
      • University of California Berkeley

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Intervention after One Week; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	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.	measured at the second home visit, after one week of the study
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of California, Berkeley
• Collaborators: National Institute of Environmental Health Sciences (NIEHS)
• Investigators: Principal Investigator: John R Balmes, MD, University of California, Berkeley

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2021
• Primary Completion (Actual): August 30, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: December 18, 2019
• First Submitted That Met QC Criteria: July 6, 2020
• First Posted (Actual): July 9, 2020

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: pediatric; asthma; ventilation; indoor air pollution; particulate matter; nitrogen dioxide; cooking
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 2018-01-10615; R21ES030173 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No