Asthma in ChildrenABHHBaAiCNCT04565964
Association Between Household Health Behaviors and Asthma in Children
A study testing change the health behaviors to clean indoor environment in people with Asthma in Children, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma in Children
- What is being tested?
- change the health behaviors to clean indoor environment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Nov 2020to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- aged 7-12 years-old who have physician-diagnosed asthma
- stable patient
Who cannot join
- acute allergies
- severe brain and heart disease
- mental illness
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Chung-Shan, 10002
Su Ta Chen, PI, 0223123456 ext. 66719, lab.of.su@gmail.com
About this study
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.
Read the 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.
- Conditions
- Asthma in Children
- Being tested
- change the health behaviors to clean indoor environment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: change the health behaviors to clean indoor environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: one month
Symptomatology (cough)
Asthma symptom is recorded daily by caregivers.
Measured: one month
Symptomatology (wheezing)
Asthma symptom is recorded daily by caregivers.
Measured: one month
Symptomatology (chest tightness)
Asthma symptom is recorded daily by caregivers.
Measured: 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.
Measured: one month
phthalates concentrations
Sampling in a fixed area in the subject's bedroom, and phthalates concentration will be analyzed in the laboratory.
Measured: 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.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start25 Nov 2020
- Primary completion29 Dec 2020 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ta-Chen Su, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04565964
- Sponsor's protocol ID
- 202006172RIND
- Acronym
- ABHHBaAiC
- Status last verified
- Sep 2020
- First submitted
- 3 Sep 2020
- Last updated
- 1 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Household Health Behaviors and Asthma in Children
- ClinicalTrials.gov ID
- NCT04565964
- Acronym / sponsor ID
- ABHHBaAiC / 202006172RIND
- Conditions
- Asthma in Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 29 Dec 2020 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 28 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health behaviors | Other | Other: change the health behaviors to clean indoor environmentHealth 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. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- aged 7-12 years-old who have physician-diagnosed asthma
- stable patient
Key exclusion criteria (3 listed)
- acute allergies
- severe brain and heart disease
- mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| change the health behaviors to clean indoor environmentSheets and all covers should be wash weekly. Clean indoor environment with a vacuum cleaner twice a week | Other | Health behaviors |
Primary outcome
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.
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.
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.
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.
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.
Symptomatology (cough)
Time frame: one month
Asthma symptom is recorded daily by caregivers.
Symptomatology (wheezing)
Time frame: one month
Asthma symptom is recorded daily by caregivers.
Symptomatology (chest tightness)
Time frame: one month
Asthma symptom is recorded daily by caregivers.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ta-Chen Su, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing change the health behaviors to clean indoor environment in people with Asthma in Children, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ta-Chen Su, PhD (+886223123456 ext. 66719, lab.of.su@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak expiratory flow changes (time frame: one month). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2020.