Association Between Household Health Behaviors and Asthma in Children (ABHHBaAiC)
Primary Purpose
Asthma in Children
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
change the health behaviors to clean indoor environment
Sponsored by
About this trial
This is an interventional other trial for Asthma in Children
Eligibility 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
Sites / Locations
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Health behaviors
Arm Description
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.
Outcomes
Primary Outcome Measures
Peak expiratory flow changes
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.
fractional concentration of exhaled nitric oxide
Before and after the intervention, test for the levels of fractional exhaled nitric oxide in the hospital to evaluate the condition of airway inflammation.
Pulmonary function test (FVC)
Before and after the intervention, test for the volumes of the forced vital capacity (FVC) in the hospital as an indicator of asthma status.
Pulmonary function test (FEV1)
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.
Pulmonary function test (FEV1/FVC ratio)
Before and after the intervention, test for the FEV1/FVC ratio in the hospital as an indicator of asthma status.
Symptomatology (cough)
Asthma symptom is recorded daily by caregivers.
Symptomatology (wheezing)
Asthma symptom is recorded daily by caregivers.
Symptomatology (chest tightness)
Asthma symptom is recorded daily by caregivers.
dust mites allergen concentrations
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.
phthalates concentrations
Sampling in a fixed area in the subject's bedroom, and phthalates concentration will be analyzed in the laboratory.
cockroach numbers
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04565964
First Posted
September 3, 2020
Last Updated
November 30, 2020
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04565964
Brief Title
Association Between Household Health Behaviors and Asthma in Children
Acronym
ABHHBaAiC
Official Title
Association Between Household Health Behaviors and Asthma in Children
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 25, 2020 (Actual)
Primary Completion Date
December 29, 2020 (Anticipated)
Study Completion Date
August 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma in Children
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Health behaviors
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
change the health behaviors to clean indoor environment
Intervention Description
Sheets and all covers should be wash weekly. Clean indoor environment with a vacuum cleaner twice a week
Primary Outcome Measure Information:
Title
Peak expiratory flow changes
Description
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.
Time Frame
one month
Title
fractional concentration of exhaled nitric oxide
Description
Before and after the intervention, test for the levels of fractional exhaled nitric oxide in the hospital to evaluate the condition of airway inflammation.
Time Frame
one month
Title
Pulmonary function test (FVC)
Description
Before and after the intervention, test for the volumes of the forced vital capacity (FVC) in the hospital as an indicator of asthma status.
Time Frame
one month
Title
Pulmonary function test (FEV1)
Description
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.
Time Frame
one month
Title
Pulmonary function test (FEV1/FVC ratio)
Description
Before and after the intervention, test for the FEV1/FVC ratio in the hospital as an indicator of asthma status.
Time Frame
one month
Title
Symptomatology (cough)
Description
Asthma symptom is recorded daily by caregivers.
Time Frame
one month
Title
Symptomatology (wheezing)
Description
Asthma symptom is recorded daily by caregivers.
Time Frame
one month
Title
Symptomatology (chest tightness)
Description
Asthma symptom is recorded daily by caregivers.
Time Frame
one month
Title
dust mites allergen concentrations
Description
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.
Time Frame
one month
Title
phthalates concentrations
Description
Sampling in a fixed area in the subject's bedroom, and phthalates concentration will be analyzed in the laboratory.
Time Frame
one month
Title
cockroach numbers
Description
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.
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ta-Chen Su, PhD
Phone
+886223123456
Ext
66719
Email
lab.of.su@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ta-Chen Su, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
State/Province
Chung-Shan
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Su Ta Chen, PI
Phone
0223123456
Ext
66719
Email
lab.of.su@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Association Between Household Health Behaviors and Asthma in Children
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