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

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ClinicalTrials.gov Identifier: NCT04464720
Recruitment Status : Recruiting
First Posted : July 9, 2020
Last Update Posted : May 3, 2021
Sponsor:
Collaborator:
National Institute of Environmental Health Sciences (NIEHS)
Information provided by (Responsible Party):
University of California, Berkeley

Tracking Information
First Submitted Date  ICMJE December 18, 2019
First Posted Date  ICMJE July 9, 2020
Last Update Posted Date May 3, 2021
Estimated Study Start Date  ICMJE May 24, 2021
Estimated Primary Completion Date August 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2020)
  • Continuously-Measured Home PM2.5 (Fine Particulate Matter) Levels Prior to Intervention [ Time Frame: 1 week in the 'Intervention after 1 week group' and 2 weeks in the 'Intervention after 2 weeks' group ]
    Home PM2.5 levels will measured in real-time using the Clarity air sensors.
  • Continuously-Measured Home PM2.5 (Fine Particulate Matter) Levels Following Intervention [ Time Frame: 2 weeks in the 'Intervention after 1 week group' and 1 week in the 'Intervention after 2 weeks' group ]
    Home PM2.5 levels will measured in real-time using the Clarity air sensors.
  • Continuously-Measured Home NO2 (Nitrogen Dioxide) Levels Prior to Intervention [ Time Frame: 1 week in the 'Intervention after 1 week group' and 2 weeks in the 'Intervention after 2 weeks' group ]
    Home NO2 levels will measured in real-time using the Clarity air sensors.
  • Continuously-Measured Home NO2 (Nitrogen Dioxide) Level Following Intervention [ Time Frame: 2 weeks in the 'Intervention after 1 week group' and 1 week in the 'Intervention after 2 weeks' group ]
    Home NO2 levels will measured in real-time using the Clarity air sensors.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2020)
  • Spirometry- Forced Vital Capacity (FVC) [ Time Frame: measured at the second home visit, after one week of the study ]
    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.
  • Spirometry- Forced Expiratory Volume in One Second (FEV1) [ Time Frame: measured at the second home visit, after one week of the study ]
    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.
  • Spirometry- Forced Expiratory Flow (FEF) [ Time Frame: measured at the second home visit, after one week of the study ]
    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.
  • Spirometry-Forced Vital Capacity (FVC) [ Time Frame: measured at the third home visit, after two weeks of the study ]
    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.
  • Spirometry- Forced Expiratory Volume in One Second (FEV1) [ Time Frame: measured at the third home visit, after two weeks of the study ]
    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.
  • Spirometry- Forced Expiratory Flow (FEF) [ Time Frame: measured at the third home visit, after two weeks of the study ]
    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.
  • Spirometry-Forced Vital Capacity (FVC) [ Time Frame: measured at the fourth home visit, after three weeks of the study ]
    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.
  • Spirometry- Forced Expiratory Volume in One Second (FEV1) [ Time Frame: measured at the fourth home visit, after three weeks of the study ]
    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.
  • Spirometry- Forced Expiratory Flow (FEF) [ Time Frame: measured at the fourth home visit, after three weeks of the study ]
    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.
  • Fractional Exhaled Nitric Oxide (FeNO) [ Time Frame: measured at the second home visit, after one week of the study ]
    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.
  • Fractional Exhaled Nitric Oxide (FeNO) [ Time Frame: measured at the third home visit, after two weeks of the study ]
    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.
  • Fractional Exhaled Nitric Oxide (FeNO) [ Time Frame: measured at the fourth home visit, after three weeks of the study ]
    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.
  • Asthma Control [ Time Frame: measured at the second home visit, after one week of the study ]
    Asthma control will be assessed using the widely-accepted, validated Asthma Control Test.
  • Asthma Control [ Time Frame: measured at the third home visit, after two weeks of the study ]
    Asthma control will be assessed using the widely-accepted, validated Asthma Control Test.
  • Asthma Control [ Time Frame: measured at the fourth home visit, after three weeks of the study ]
    Asthma control will be assessed using the widely-accepted, validated Asthma Control Test.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AIM to Improve Asthma: Airflow Improvements During Meal-Prep
Official Title  ICMJE AIM to Improve Asthma: Airflow Improvements During Meal-Prep
Brief Summary The investigators propose a pilot, randomized trial of kitchen ventilation in the homes of children with asthma using a youth engaged research strategy.
Detailed Description In this trial of 60 children ages 6-12 with asthma, the investigators will randomize 30 children and their households to receive an intensive home kitchen ventilation intervention after one week of baseline data collection and the other 30 to receive the intervention after two weeks of baseline data collection. This design will allow for analysis as both a randomized controlled trial, and as a before/after trial, allowing for the benefits of both designs. 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, one week after 30 families have received the intervention and a final week after all remaining families receive the cooking ventilation intervention, to assess for changes within each household as well as between groups. 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), reported symptoms, and asthma quality of life after the baseline and each 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This is a parallel trial with two groups, where one group receives the intervention following one week of baseline data collection. The other group will receive the intervention after a delay (one week later).
Masking: None (Open Label)
Masking Description:
Participants and field staff can not be masked to the intervention, however the data analysts will be masked.
Primary Purpose: Prevention
Condition  ICMJE
  • Asthma in Children
  • Pollution; Exposure
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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 two weeks.
    Intervention: Behavioral: Cooking Ventilation Intervention
  • Intervention after Two Weeks
    This arm will have baseline data on air pollutant levels, stove use and range hood use collected for two weeks prior to receiving an educational intervention aimed at increasing use of the range hood. Data following the intervention will be collected for an additional one week.
    Intervention: Behavioral: Cooking Ventilation Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 6, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 30, 2021
Estimated Primary Completion Date August 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Physician Diagnosis of asthma
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Stephanie Holm, MD MPH (510) 621-3250 RichmondAIMstudy@gmail.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04464720
Other Study ID Numbers  ICMJE 2018-01-10615
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Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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.
Responsible Party University of California, Berkeley
Study Sponsor  ICMJE University of California, Berkeley
Collaborators  ICMJE National Institute of Environmental Health Sciences (NIEHS)
Investigators  ICMJE
Principal Investigator: John R Balmes, MD University of California, Berkeley
PRS Account University of California, Berkeley
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP