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Completed

NCT Number: NCT04464720

AIM to Improve Asthma: Airflow Improvements During Meal-Prep

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

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Key information

Conditions

Asthma in Children Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pollution; Exposure Respiration Disorders Respiratory Aspiration Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California Berkeley

Berkeley, California, 94720, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cooking Ventilation Intervention

Behavioral

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 outcomes

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

    Time frame: 1-2 weeks

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

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

    Time frame: 1-2 weeks

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

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

    Time frame: 1-2 weeks

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

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

    Time frame: 1-2 weeks

    Home NO2 levels were measured with eLichens sensors

Secondary outcomes

  1. Spirometry- Forced Vital Capacity (FVC)

    Time frame: measured at the end of the pre-intervention interval

    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.

  2. Spirometry- Forced Expiratory Volume in One Second (FEV1)

    Time frame: measured at the end of the pre-intervention interval

    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.

  3. Spirometry-Forced Vital Capacity (FVC)

    Time frame: 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.

  4. Spirometry- Forced Expiratory Volume in One Second (FEV1)

    Time frame: 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.

  5. Fractional Exhaled Nitric Oxide (FeNO)

    Time frame: measured at the end of the pre-intervention interval

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

  6. Fractional Exhaled Nitric Oxide (FeNO)

    Time frame: 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.

  7. Asthma Control

    Time frame: measured at the end of the pre-intervention 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.

  8. Asthma Control

    Time frame: measured at the end of the post-intervention 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.

Sponsors and collaborators

Lead sponsor

University of California, Berkeley

Other

Collaborators

  • National Institute of Environmental Health Sciences (NIEHS)

Registry information

Acronym: AIM

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 9, 2020
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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