NCT04565964

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2020

Completed
25 days until next milestone

First Posted

Study publicly available on registry

September 28, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

November 25, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

December 1, 2020

Status Verified

September 1, 2020

Enrollment Period

1 month

First QC Date

September 3, 2020

Last Update Submit

November 30, 2020

Conditions

Asthma in Children

Outcome Measures

Primary Outcomes (11)

  • 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

Study Arms (1)

Health behaviors

OTHER

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

Interventions

change the health behaviors to clean indoor environmentOTHER

Sheets and all covers should be wash weekly. Clean indoor environment with a vacuum cleaner twice a week

Health behaviors

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Chung-Shan, 10002, Taiwan

RECRUITING

Study Officials

  • Ta-Chen Su, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ta-Chen Su, PhD

CONTACT

+886223123456lab.of.su@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2020

First Posted

September 28, 2020

Study Start

November 25, 2020

Primary Completion

December 29, 2020

Study Completion

August 31, 2021

Last Updated

December 1, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)