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Association Between Household Health Behaviors and Asthma in Children (ABHHBaAiC)

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ClinicalTrials.gov Identifier: NCT04565964
Recruitment Status : Recruiting
First Posted : September 28, 2020
Last Update Posted : December 1, 2020
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Study Description
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Brief Summary:
This study plan to study the association between household health behavior (cleaning habits) and children's asthma. In addition, reconfirm the health effects of indoor environmental exposure to phthalates plasticizers, mite, fungi, and bacteria, and cockroaches on children's asthma. Thus, the investigators can provide a non-pharmacological intervention to reduce the disease burden of children's asthma and allergic diseases.

Condition or disease Intervention/treatment Phase
Asthma in Children Other: change the health behaviors to clean indoor environment Not Applicable

Detailed Description:

The investigators plan to invite 80 children, aged 7-12 years-old who have physician-diagnosed asthma, and another age- and gender-matched children without asthma to join our study. First, obtaining clinical data of disease status, and ask participants to fill out questionnaires after recruiting. Second, participants have to record body temperature, peak expiratory flow, heart rate, finger O2 saturation percentage, asthma attack frequency continuously by care-giver every day. Third, the investigators will perform indoor environmental assessments in the subject's house, including indoor air quality, dust samples, culture for fungi and bacteria, and cockroaches. The investigators will also count the dust mites and measure phthalates concentration in every dust sample.

Then, health behavior intervention for one month will be provided to every participant. The investigators will teach children's guardians (care-giver) how to change the health behaviors to clean indoor environment, including the health behaviors in bedroom, kitchen room, restroom, refrigerator, washing machine, and incense burning hall. After 1 months, the investigators will investigate whether changing health behavior affects the exposure of phthalates, dust mites, fungi, bacteria, and cockroaches, and evaluate the effects of health behavior intervention on the clinical status of children's asthma. Children's asthma severity assessment will be recorded by ACT and also by symptomatology every day. Household health behaviors (cleaning habits) questionnaires also will be completed per week and continuously for 4 weeks.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Association Between Household Health Behaviors and Asthma in Children
Actual Study Start Date : November 25, 2020
Estimated Primary Completion Date : December 29, 2020
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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Arm Intervention/treatment
Health behaviors
Health behavior intervention for one month will be provided to every participant. We will teach children's guardians (care-giver) how to change the health behaviors to clean indoor environment, including the health behaviors in bedroom, kitchen room, restroom, refrigerator, washing machine, and incense burning hall.
 Other: change the health behaviors to clean indoor environment
Sheets and all covers should be wash weekly. Clean indoor environment with a vacuum cleaner twice a week


Outcome Measures
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Primary Outcome Measures :
  1. Peak expiratory flow changes [ Time Frame: one month ]
    Using peak flow meter to monitor the participant's peak expiratory flow values in the morning and evening to effectively evaluate subject's asthma status.

  2. fractional concentration of exhaled nitric oxide [ Time Frame: one month ]
    Before and after the intervention, test for the levels of fractional exhaled nitric oxide in the hospital to evaluate the condition of airway inflammation.

  3. Pulmonary function test (FVC) [ Time Frame: one month ]
    Before and after the intervention, test for the volumes of the forced vital capacity (FVC) in the hospital as an indicator of asthma status.

  4. Pulmonary function test (FEV1) [ Time Frame: one month ]
    Before and after the intervention, test for the volumes of the forced expiratory volume in one second (FEV1) in the hospital as an indicator of asthma status.

  5. Pulmonary function test (FEV1/FVC ratio) [ Time Frame: one month ]
    Before and after the intervention, test for the FEV1/FVC ratio in the hospital as an indicator of asthma status.

  6. Symptomatology (cough) [ Time Frame: one month ]
    Asthma symptom is recorded daily by caregivers.

  7. Symptomatology (wheezing) [ Time Frame: one month ]
    Asthma symptom is recorded daily by caregivers.

  8. Symptomatology (chest tightness) [ Time Frame: one month ]
    Asthma symptom is recorded daily by caregivers.

  9. dust mites allergen concentrations [ Time Frame: one month ]
    Before and after the intervention, allergen concentrations will be sampled in a fixed area in the subject's bedroom, and dust mites' antibody will be analyzed in the laboratory.

  10. phthalates concentrations [ Time Frame: one month ]
    Sampling in a fixed area in the subject's bedroom, and phthalates concentration will be analyzed in the laboratory.

  11. cockroach numbers [ Time Frame: one month ]
    Before and after the intervention, count the numbers of cockroach will be sampled for every week, in a fixed area in the subject's bedroom.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • aged 7-12 years-old who have physician-diagnosed asthma
  • stable patient

Exclusion Criteria:

  • acute allergies
  • severe brain and heart disease
  • mental illness
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04565964


Contacts
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Contact: Ta-Chen Su, PhD +886223123456 ext 66719 lab.of.su@gmail.com

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Chung-Shan, Taiwan, 10002
Contact: Su Ta Chen, PI    0223123456 ext 66719    lab.of.su@gmail.com   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Ta-Chen Su, PhD National Taiwan University Hospital
More Information
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT04565964    
Other Study ID Numbers: 202006172RIND
First Posted: September 28, 2020    Key Record Dates
Last Update Posted: December 1, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases