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

November 30, 2020 updated by: National Taiwan University Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
    • Chung-Shan
      • Taipei, Chung-Shan, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Peak expiratory flow changes
Time Frame: 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.
one month
fractional concentration of exhaled nitric oxide
Time Frame: 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.
one month
Pulmonary function test (FVC)
Time Frame: 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.
one month
Pulmonary function test (FEV1)
Time Frame: 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.
one month
Pulmonary function test (FEV1/FVC ratio)
Time Frame: one month
Before and after the intervention, test for the FEV1/FVC ratio in the hospital as an indicator of asthma status.
one month
Symptomatology (cough)
Time Frame: one month
Asthma symptom is recorded daily by caregivers.
one month
Symptomatology (wheezing)
Time Frame: one month
Asthma symptom is recorded daily by caregivers.
one month
Symptomatology (chest tightness)
Time Frame: one month
Asthma symptom is recorded daily by caregivers.
one month
dust mites allergen concentrations
Time Frame: 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.
one month
phthalates concentrations
Time Frame: one month
Sampling in a fixed area in the subject's bedroom, and phthalates concentration will be analyzed in the laboratory.
one month
cockroach numbers
Time Frame: 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.
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ta-Chen Su, PhD, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 25, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 29, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 1, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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