Clinical trial NCT04565964: Association Between Household Health Behaviors and Asthma in Children
Official title: Association Between Household Health Behaviors and Asthma in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma in Children
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-09-28
Enrollment: 80
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Peak expiratory flow changes
timeFrame: one month
measure: fractional concentration of exhaled nitric oxide
timeFrame: one month
measure: Pulmonary function test (FVC)
timeFrame: one month
measure: Pulmonary function test (FEV1)
timeFrame: one month
measure: Pulmonary function test (FEV1/FVC ratio)
timeFrame: one month
measure: Symptomatology (cough)
timeFrame: one month
measure: Symptomatology (wheezing)
timeFrame: one month
measure: Symptomatology (chest tightness)
timeFrame: one month
measure: dust mites allergen concentrations
timeFrame: one month
measure: phthalates concentrations
timeFrame: one month
measure: cockroach numbers
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: Chung-Shan
Study officials:
affiliation: National Taiwan University Hospital
name: Ta-Chen Su, PhD
role: PRINCIPAL_INVESTIGATOR
References: