Trial Outcomes & Findings for AIM to Improve Asthma: Airflow Improvements During Meal-Prep (NCT NCT04464720)

NCT ID: NCT04464720

Last Updated: 2024-10-17

Results Overview

Home PM2.5 levels were measured in real-time with eLichens sensors.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 19 participants
• Primary outcome timeframe: 1-2 weeks
• Results posted on: 2024-10-17

Participant Flow

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).

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.

Participant milestones

Measure	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.
Pre-Intervention STARTED	19
Pre-Intervention COMPLETED	18
Pre-Intervention NOT COMPLETED	1
Post-Intervention STARTED	18
Post-Intervention COMPLETED	18
Post-Intervention NOT COMPLETED	0

Reasons for withdrawal

Measure

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.

Pre-Intervention Intervention (hood retrofit) beyond the scope available in the study, so participation ended.

1

Baseline Characteristics

AIM to Improve Asthma: Airflow Improvements During Meal-Prep

Baseline characteristics by cohort

Measure	Intervention After 1-2 Weeks n=23 Participants 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.
Sex/Gender, Customized Sex · male	10 Participants n=5 Participants
Sex/Gender, Customized Sex · female	13 Participants n=5 Participants
Sex/Gender, Customized Sex · intersex	0 Participants n=5 Participants
Sex/Gender, Customized Sex · other	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants
Asthma Diagnosis Ever diagnosed with asthma	7 Participants n=5 Participants
Asthma Diagnosis Never diagnosed with asthma	16 Participants n=5 Participants
Age, Continuous	8 years n=5 Participants

PRIMARY outcome

Timeframe: 1-2 weeks

Home PM2.5 levels were measured in real-time with eLichens sensors.

Outcome measures

Measure	Intervention After 1-2 Weeks n=19 Participants 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.
Continuously-Measured Home PM2.5 (Fine Particulate Matter) Levels Prior to Intervention	10200 (mcg/m3)*min Interval 275.0 to 65200.0

PRIMARY outcome

Timeframe: 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.

Home PM2.5 levels were measured in real-time using the eLichens sensors

Outcome measures

Measure	Intervention After 1-2 Weeks n=18 Participants 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.
Continuously-Measured Home PM2.5 (Fine Particulate Matter) Levels Following Intervention	4570 (mcg/m3)*min Interval 0.0 to 31000.0

PRIMARY outcome

Timeframe: 1-2 weeks

Home NO2 levels were measured in real-time using eLichens sensors

Outcome measures

Measure	Intervention After 1-2 Weeks n=19 Participants 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.
Continuously-Measured Home NO2 (Nitrogen Dioxide) Levels Prior to Intervention	50600 ppb*min Interval 3400.0 to 181000.0

PRIMARY outcome

Timeframe: 1-2 weeks

Home NO2 levels were measured with eLichens sensors

Outcome measures

Measure	Intervention After 1-2 Weeks n=18 Participants 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.
Continuously-Measured Home NO2 (Nitrogen Dioxide) Level Following Intervention	15900 ppb*min Interval 3740.0 to 88500.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Intervention After 1-2 Weeks n=11 Participants 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.
Spirometry- Forced Vital Capacity (FVC)	0.7 Z-score Interval -1.6 to 1.5

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Intervention After 1-2 Weeks n=11 Participants 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.
Spirometry- Forced Expiratory Volume in One Second (FEV1)	0.5 Z-score Interval -3.0 to 1.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intervention After 1-2 Weeks n=11 Participants 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.
Spirometry-Forced Vital Capacity (FVC)	-0.3 Z-score Interval -1.7 to 0.8

SECONDARY outcome

Timeframe: measured at the end of the post-intervention interval

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.

Outcome measures

Measure	Intervention After 1-2 Weeks n=11 Participants 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.
Spirometry- Forced Expiratory Volume in One Second (FEV1)	-0.5 Z-score Interval -2.3 to 0.7

SECONDARY outcome

Timeframe: 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.

FeNO s a non-invasive measure of airways inflammation. FeNO was performed using a NIOX Vero device.

Outcome measures

Measure	Intervention After 1-2 Weeks n=9 Participants 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.
Fractional Exhaled Nitric Oxide (FeNO)	19.7 ppb Interval 8.0 to 53.0

SECONDARY outcome

Timeframe: measured at the end of the post-intervention interval

FeNO is a non-invasive measure of airways inflammation. FeNO will be performed using a NIOX Vero device.

Outcome measures

Measure	Intervention After 1-2 Weeks n=12 Participants 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.
Fractional Exhaled Nitric Oxide (FeNO)	22.5 ppb Interval 5.0 to 60.7

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Intervention After 1-2 Weeks n=4 Participants 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.
Asthma Control	25 score on a scale Interval 23.0 to 26.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Intervention After 1-2 Weeks n=3 Participants 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.
Asthma Control	26 score on a scale Interval 24.0 to 27.0

Adverse Events

Intervention After 1-2 Weeks

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Stephanie M Holm

University of California San Francisco

Phone: 415-514-0878

Email: stephanie.holm@ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place