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

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.

Study Overview

• Status: Unknown
• Conditions: Asthma in Children
• Intervention / Treatment: Other: change the health behaviors to clean indoor environment

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Chung-Shan
    • Taipei, Chung-Shan, Taiwan, 10002
      • Recruiting
      • National Taiwan University Hospital
      • Contact: Su Ta Chen, PI; Phone Number: 66719 0223123456; Email: lab.of.su@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Ta-Chen Su, PhD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2020
• Primary Completion (Anticipated): December 29, 2020
• Study Completion (Anticipated): August 31, 2021

Study Registration Dates

• First Submitted: September 3, 2020
• First Submitted That Met QC Criteria: September 21, 2020
• First Posted (Actual): September 28, 2020

Study Record Updates

• Last Update Posted (Actual): December 1, 2020
• Last Update Submitted That Met QC Criteria: November 30, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 202006172RIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No