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Asthma in ChildrenAIMNCT04464720

AIM to Improve Asthma: Airflow Improvements During Meal-Prep

A study testing Cooking Ventilation Intervention in people with Asthma in Children and Pollution; Exposure, run by University of California, Berkeley at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigators propose a pilot trial of kitchen ventilation in the homes of children using a youth engaged research strategy. Read more about this study

Who is it for?
Ages 6 to 12 years
Conditions the study is for
Asthma in Children, Pollution; Exposure
What is being tested?
Cooking Ventilation Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteUnited States
Study dates
24 May 2021to 30 Dec 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Household has a gas stove
  • Household has a range hood that vents to the outdoors
  • Household in Richmond or San Pablo

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California Berkeley

    Berkeley, California, 94720

Other trials in United States

About this study

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

Read the 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.

Being tested
Cooking Ventilation Intervention
Keywords
asthma, pediatric, indoor air pollution, particulate matter, nitrogen dioxide, cooking, ventilation
Medical subject headings
Asthma, Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cooking Ventilation InterventionBehavioural

    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.

Study groups in NCT04464720
Study groupRoleWhat they receive
Intervention after One WeekOtherThis 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.
Receives: Behavioral: Cooking Ventilation Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Continuously-Measured Home PM2.5 (Fine Particulate Matter) Levels Prior to Intervention

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

    Measured: 1-2 weeks

  2. Continuously-Measured Home PM2.5 (Fine Particulate Matter) Levels Following Intervention

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

    Measured: 1-2 weeks

  3. Continuously-Measured Home NO2 (Nitrogen Dioxide) Levels Prior to Intervention

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

    Measured: 1-2 weeks

  4. Continuously-Measured Home NO2 (Nitrogen Dioxide) Level Following Intervention

    Home NO2 levels were measured with eLichens sensors

    Measured: 1-2 weeks

Secondary outcomes (8)

  1. 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.

    Measured: measured at the end of the pre-intervention interval

  2. 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: measured at the end of the pre-intervention interval

  3. 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: measured at the end of the post-intervention interval

  4. 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: measured at the end of the post-intervention interval

  5. Fractional Exhaled Nitric Oxide (FeNO)

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

    Measured: measured at the end of the pre-intervention interval

  6. Fractional Exhaled Nitric Oxide (FeNO)

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

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

  7. 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: measured at the end of the pre-intervention interval

  8. 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: measured at the end of the post-intervention interval

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2020
  2. Study start24 May 2021
  3. Primary completion30 Aug 2022
  4. Study completion30 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04464720
Sponsor's protocol ID
2018-01-10615
Other IDs
R21ES030173
Acronym
AIM
Status last verified
Sep 2024
First submitted
18 Dec 2019
Last updated
17 Oct 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 39521897

Questions about this trial

What is this clinical trial studying?

A study testing Cooking Ventilation Intervention in people with Asthma in Children and Pollution; Exposure, run by University of California, Berkeley at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Continuously-Measured Home PM2.5 (Fine Particulate Matter) Levels Prior to Intervention (time frame: 1-2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04464720, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.

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