Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
Study NCT ID:
NCT04464720
Status:
COMPLETED
Last Update Posted:
2024-10-17
First Post:
2019-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
AIM to Improve Asthma: Airflow Improvements During Meal-Prep
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'stephanie.holm@ucsf.edu', 'phone': '415-514-0878', 'title': 'Dr. Stephanie M Holm', 'organization': 'University of California San Francisco'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'We monitored for Adverse Events from enrollment and through the over the full period of data collection which ranged from 12 to 54 days among different participants (based on changing protocols during the pandemic).', 'description': 'No adverse events occured.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention After 1-2 Weeks', 'description': '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.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Continuously-Measured Home PM2.5 (Fine Particulate Matter) Levels Prior to Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention After 1-2 Weeks', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '10200', 'groupId': 'OG000', 'lowerLimit': '275', 'upperLimit': '65200'}]}]}], 'analyses': [{'pValue': '0.050', 'groupIds': ['OG000'], 'groupDescription': 'comparing pre and post intervention PM2.5', 'statisticalMethod': 'Wilcoxon Ranked Sum', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '1-2 weeks', 'description': 'Home PM2.5 levels were measured in real-time with eLichens sensors.', 'unitOfMeasure': '(mcg/m3)*min', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Continuously-Measured Home PM2.5 (Fine Particulate Matter) Levels Following Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention After 1-2 Weeks', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '4570', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '31000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1-2 weeks', 'description': 'Home PM2.5 levels were measured in real-time using the eLichens sensors', 'unitOfMeasure': '(mcg/m3)*min', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': "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."}, {'type': 'PRIMARY', 'title': 'Continuously-Measured Home NO2 (Nitrogen Dioxide) Levels Prior to Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention After 1-2 Weeks', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '50600', 'groupId': 'OG000', 'lowerLimit': '3400', 'upperLimit': '181000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1-2 weeks', 'description': 'Home NO2 levels were measured in real-time using eLichens sensors', 'unitOfMeasure': 'ppb*min', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Continuously-Measured Home NO2 (Nitrogen Dioxide) Level Following Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention After 1-2 Weeks', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '15900', 'groupId': 'OG000', 'lowerLimit': '3740', 'upperLimit': '88500'}]}]}], 'analyses': [{'pValue': '0.043', 'groupIds': ['OG000'], 'groupDescription': 'comparing pre v post intervention NO2', 'statisticalMethod': 'Wilcoxon Ranked Sum', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '1-2 weeks', 'description': 'Home NO2 levels were measured with eLichens sensors', 'unitOfMeasure': 'ppb*min', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Spirometry- Forced Vital Capacity (FVC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention After 1-2 Weeks', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '-1.6', 'upperLimit': '1.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'measured at the end of the pre-intervention interval', 'description': '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.\n\nZ-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.', 'unitOfMeasure': 'Z-score', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'spirometry can be technically challenging, especially for younger children, and thus we only have results for a subset of the participants.'}, {'type': 'SECONDARY', 'title': 'Spirometry- Forced Expiratory Volume in One Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention After 1-2 Weeks', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '-3.0', 'upperLimit': '1.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'measured at the end of the pre-intervention interval', 'description': '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.\n\nZ-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.', 'unitOfMeasure': 'Z-score', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Spirometry-Forced Vital Capacity (FVC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention After 1-2 Weeks', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000', 'lowerLimit': '-1.7', 'upperLimit': '0.8'}]}]}], 'analyses': [{'pValue': '0.056', 'groupIds': ['OG000'], 'groupDescription': 'comparing FVC pre and post intervention', 'statisticalMethod': 'Wilcoxon Ranked Sum', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'measured at the end of the post-intervention interval', 'description': '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.\n\nZ-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.', 'unitOfMeasure': 'Z-score', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Spirometry- Forced Expiratory Volume in One Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention After 1-2 Weeks', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'groupId': 'OG000', 'lowerLimit': '-2.3', 'upperLimit': '0.7'}]}]}], 'analyses': [{'pValue': '0.058', 'groupIds': ['OG000'], 'groupDescription': 'Comparing FEV1 pre and post intervention', 'statisticalMethod': 'Wilcoxon Signed Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'measured at the end of the post-intervention interval', 'description': '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.\n\nZ-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.', 'unitOfMeasure': 'Z-score', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fractional Exhaled Nitric Oxide (FeNO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention After 1-2 Weeks', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': '53.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'measured at the end of the pre-intervention interval', 'description': 'FeNO s a non-invasive measure of airways inflammation. FeNO was performed using a NIOX Vero device.', 'unitOfMeasure': 'ppb', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This is again a cognitively tricky maneuver to execute, so these 9 children are those that were able to complete FeNO.'}, {'type': 'SECONDARY', 'title': 'Fractional Exhaled Nitric Oxide (FeNO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention After 1-2 Weeks', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.5', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '60.7'}]}]}], 'analyses': [{'pValue': '0.058', 'groupIds': ['OG000'], 'groupDescription': 'comparing FeNO pre v post intervention', 'statisticalMethod': 'Wilcoxon Ranked Sum', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'measured at the end of the post-intervention interval', 'description': 'FeNO is a non-invasive measure of airways inflammation. FeNO will be performed using a NIOX Vero device.', 'unitOfMeasure': 'ppb', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Asthma Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention After 1-2 Weeks', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '26'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'measured at the end of the pre-intervention interval', 'description': 'Asthma control was assessed using the widely-accepted, validated Childhood Asthma Control Test (cACT) for children with asthma.\n\nThe 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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'assessed only among those with asthma, and 4/4 completed the survey in this interval'}, {'type': 'SECONDARY', 'title': 'Asthma Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention After 1-2 Weeks', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '27'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'measured at the end of the post-intervention interval', 'description': 'Asthma control was assessed using the widely-accepted, validated Childhood Asthma Control Test (cACT) for children with asthma.\n\nThe 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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Assessed only in those with asthma. 3/4 participants completed this survey in the post-interval.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention After 1-2 Weeks', 'description': '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.\n\nCooking 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.'}], 'periods': [{'title': 'Pre-Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Intervention (hood retrofit) beyond the scope available in the study, so participation ended.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'Post-Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '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).', 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention After 1-2 Weeks', 'description': '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.\n\nCooking 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.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000', 'lowerLimit': '7.3', 'upperLimit': '9.7'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Sex', 'categories': [{'title': 'male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'intersex', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'other', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Asthma Diagnosis', 'classes': [{'categories': [{'title': 'Ever diagnosed with asthma', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Never diagnosed with asthma', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Though 23 participants screened in for the study and consented to collection of screening data, 3 participants were unable to get initial visits scheduled in time to complete the study prior to the loss of study staff. 1 participant we stopped being able to reach. Thus, 19 were consented for the full study and began baseline.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-01', 'size': 157500, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-06-03T23:47', 'hasProtocol': True}, {'date': '2024-02-12', 'size': 3862592, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-06-03T23:33', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a trial with a single group, where they receive the intervention following one week of baseline data collection.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-25', 'studyFirstSubmitDate': '2019-12-18', 'resultsFirstSubmitDate': '2024-06-05', 'studyFirstSubmitQcDate': '2020-07-06', 'lastUpdatePostDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-25', 'studyFirstPostDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Continuously-Measured Home PM2.5 (Fine Particulate Matter) Levels Prior to Intervention', 'timeFrame': '1-2 weeks', 'description': 'Home PM2.5 levels were measured in real-time with eLichens sensors.'}, {'measure': 'Continuously-Measured Home PM2.5 (Fine Particulate Matter) Levels Following Intervention', 'timeFrame': '1-2 weeks', 'description': 'Home PM2.5 levels were measured in real-time using the eLichens sensors'}, {'measure': 'Continuously-Measured Home NO2 (Nitrogen Dioxide) Levels Prior to Intervention', 'timeFrame': '1-2 weeks', 'description': 'Home NO2 levels were measured in real-time using eLichens sensors'}, {'measure': 'Continuously-Measured Home NO2 (Nitrogen Dioxide) Level Following Intervention', 'timeFrame': '1-2 weeks', 'description': 'Home NO2 levels were measured with eLichens sensors'}], 'secondaryOutcomes': [{'measure': 'Spirometry- Forced Vital Capacity (FVC)', 'timeFrame': 'measured at the end of the pre-intervention interval', 'description': '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.\n\nZ-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.'}, {'measure': 'Spirometry- Forced Expiratory Volume in One Second (FEV1)', 'timeFrame': 'measured at the end of the pre-intervention interval', 'description': '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.\n\nZ-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.'}, {'measure': 'Spirometry-Forced Vital Capacity (FVC)', 'timeFrame': 'measured at the end of the post-intervention interval', 'description': '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.\n\nZ-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.'}, {'measure': 'Spirometry- Forced Expiratory Volume in One Second (FEV1)', 'timeFrame': 'measured at the end of the post-intervention interval', 'description': '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.\n\nZ-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.'}, {'measure': 'Fractional Exhaled Nitric Oxide (FeNO)', 'timeFrame': 'measured at the end of the pre-intervention interval', 'description': 'FeNO s a non-invasive measure of airways inflammation. FeNO was performed using a NIOX Vero device.'}, {'measure': 'Fractional Exhaled Nitric Oxide (FeNO)', 'timeFrame': 'measured at the end of the post-intervention interval', 'description': 'FeNO is a non-invasive measure of airways inflammation. FeNO will be performed using a NIOX Vero device.'}, {'measure': 'Asthma Control', 'timeFrame': 'measured at the end of the pre-intervention interval', 'description': 'Asthma control was assessed using the widely-accepted, validated Childhood Asthma Control Test (cACT) for children with asthma.\n\nThe 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.'}, {'measure': 'Asthma Control', 'timeFrame': 'measured at the end of the post-intervention interval', 'description': 'Asthma control was assessed using the widely-accepted, validated Childhood Asthma Control Test (cACT) for children with asthma.\n\nThe 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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['asthma', 'pediatric', 'indoor air pollution', 'particulate matter', 'nitrogen dioxide', 'cooking', 'ventilation'], 'conditions': ['Asthma in Children', 'Pollution; Exposure']}, 'referencesModule': {'references': [{'pmid': '39521897', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The investigators propose a pilot trial of kitchen ventilation in the homes of children using a youth engaged research strategy.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Household has a gas stove\n* Household has a range hood that vents to the outdoors\n* Household in Richmond or San Pablo\n\nExclusion Criteria:\n\n* Child has other significant medical illnesses (e.g. prematurity, diabetes)\n* living with a smoker who smokes indoors\n* family knows they will not have stable housing for the period of the study\n* Parent is not fluent in English.'}, 'identificationModule': {'nctId': 'NCT04464720', 'acronym': 'AIM', 'briefTitle': 'AIM to Improve Asthma: Airflow Improvements During Meal-Prep', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Berkeley'}, 'officialTitle': 'AIM to Improve Asthma: Airflow Improvements During Meal-Prep', 'orgStudyIdInfo': {'id': '2018-01-10615'}, 'secondaryIdInfos': [{'id': 'R21ES030173', 'link': 'https://reporter.nih.gov/quickSearch/R21ES030173', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Intervention after One Week', 'description': '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.', 'interventionNames': ['Behavioral: Cooking Ventilation Intervention']}], 'interventions': [{'name': 'Cooking Ventilation Intervention', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Intervention after One Week']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94720', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'University of California Berkeley', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}], 'overallOfficials': [{'name': 'John R Balmes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Berkeley'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Berkeley', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Environmental Health Sciences (NIEHS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}