Association Between Household Health Behaviors and Asthma in Children

Asthma in Children Clinical Trial

— ABHHBaAiC  

Official title:

Association Between Household Health Behaviors and Asthma in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04565964
• Other study ID #: 202006172RIND
• Status: Recruiting
• Phase: N/A
• Start date: November 25, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: September 2020
• Source: National Taiwan University Hospital
• Contact: Ta-Chen Su, PhD
• Phone: +886223123456
• Email: lab.of.su[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 31, 2021
• Est. primary completion date: December 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei	Chung-Shan

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one month
Primary	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.	one month
Primary	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.	one month
Primary	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.	one month
Primary	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.	one month
Primary	Symptomatology (cough)	Asthma symptom is recorded daily by caregivers.	one month
Primary	Symptomatology (wheezing)	Asthma symptom is recorded daily by caregivers.	one month
Primary	Symptomatology (chest tightness)	Asthma symptom is recorded daily by caregivers.	one month
Primary	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.	one month
Primary	phthalates concentrations	Sampling in a fixed area in the subject's bedroom, and phthalates concentration will be analyzed in the laboratory.	one month
Primary	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.	one month