Association Between Household Health Behaviors and Asthma in Children

Not Applicable

• Conditions: Asthma in Children
• Interventions: Other: change the health behaviors to clean indoor environment

• Registration Number: NCT04565964
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-03
• Study First Submitted QC: 2020-09-21
• Study First Posted: 2020-09-28
• Study Start: 2020-11-25
• Last Update Submitted: 2020-11-30
• Last Update Posted: 2020-12-01
• Primary Completion: 2020-12-29
• Study Completion: 2021-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

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Exclusion Criteria

• acute allergies
• severe brain and heart disease
• mental illness

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Health behaviors	change the health behaviors to clean indoor environment	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.

Primary Outcome Measures

Name	Time	Method
Symptomatology (chest tightness)	one month	Asthma symptom is recorded daily by caregivers.
Pulmonary function test (FEV1/FVC ratio)	one month	Before and after the intervention, test for the FEV1/FVC ratio in the hospital as an indicator of asthma status.
phthalates concentrations	one month	Sampling in a fixed area in the subject's bedroom, and phthalates concentration will be analyzed in the laboratory.
Symptomatology (wheezing)	one month	Asthma symptom is recorded daily by caregivers.
Peak expiratory flow changes	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.
fractional concentration of exhaled nitric oxide	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.
Pulmonary function test (FVC)	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.
dust mites allergen concentrations	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.
Pulmonary function test (FEV1)	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.
Symptomatology (cough)	one month	Asthma symptom is recorded daily by caregivers.
cockroach numbers	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.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Chung-Shan, Taiwan