ObesityNCT05918874
Postnatal Nutrition and Physical Activity in Obese Asthmatic Children
An observational study of Obesity and Asthma in Children, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to compare the duration of breast milk intake, vitamin D intake, asthma control level and physical activity levels between obese asthmatic children and non-obese children. This was a prospective study in children aged 8-17 years with asthma. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Obesity, Asthma in Children
- What is being tested?
- Descriptive questionnaire
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jan 2022to 23 May 2022
- Phase
- Observational
- 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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Volunteer children between the ages of 8-17 years with a diagnosis of asthma admitted to the Department of Pediatrics.
Who may be able to join
- diagnosed with asthma by a pediatrician,
- not in the attack process,
- no mental problems,
- do not have any systemic disease accompanying asthma (diabetes, etc.)
- children who voluntarily agreed to participate in the study
Who cannot join
- severe posture disorders
- idiopathic scoliosis and idiopathic rheumatic disease
- history of orthopedic surgery
- children with mental retardation or a neurological problem
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege university faculty of health sciences
Izmir, Karsıyaka, 35575
About this study
Official title: Evaluation of Postnatal Nutritional Status and Physical Activity Level in Obese Asthmatic Children
The aim of this study was to compare the duration of breast milk intake, vitamin D intake, asthma control level and physical activity levels between obese asthmatic children and non-obese children. This was a prospective study in children aged 8-17 years with asthma. Asthma control level was evaluated by asthma control test and physical activity level was evaluated by Physical Activity Questionnaire for Children (IPAQ-C) and leisure time activity scale.
Read the detailed description
Asthma and obesity, which are important public health problems and are common in childhood, are chronic diseases. The aim of this study was to compare breastfeeding duration, vitamin D intake, asthma control and physical activity levels between obese asthmatic children and non-obese children.
The study was a prospective study conducted in children aged 8-17 years with asthma. Demographic information of the children was recorded. Asthma control level was assessed by asthma control test and physical activity level was assessed by Physical Activity Questionnaire for Children (IPAQ-C) and leisure time activity scale.
It was conducted as a single-blind, prospective study in which the patients were randomized by simple randomization method as obese asthmatic children (experimental group) and non-obese asthmatic children (control group) according to the order of admission to the hospital.
- Conditions
- Obesity, Asthma in Children
- Being tested
- Descriptive questionnaire
- Keywords
- Childhood asthma, Obesity, Physical activity, Postnatal nutrition
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Descriptive questionnaireOther
Questionnaires were administered to calculate whether the children were obese or not, to determine their asthma control levels, to determine their physical activity levels and to determine their leisure time activities.
| Study group | Role | What they receive |
|---|---|---|
| obese | The demographic characteristics of the children, type of asthma, dietary habits, socioeconomic income level and number of meals were asked to the child; the use of vitamin D in childhood and for how long, whether the child was breastfed or not, how many months the child was breastfed if breastfed, whether the mother had a smoking habit, and whether the mother had urinary tract infection during pregnancy were asked to the mother.
Asthma control level was recorded according to the asthma control test. Body mass index was calculated according to the Center of Disease Control and Prevention. The leisure-time activity scale and the International Physical Activity Questionnaire for Children-C (IPAQ-C) were used to assess physical activity level. Receives: Other: Descriptive questionnaire | |
| non-obese | The demographic characteristics of the children, type of asthma, dietary habits, socioeconomic income level and number of meals were asked to the child; the use of vitamin D in childhood and for how long, whether the child was breastfed or not, how many months the child was breastfed if breastfed, whether the mother had a smoking habit, and whether the mother had urinary tract infection during pregnancy were asked to the mother.
Asthma control level was recorded according to the asthma control test. Body mass index was calculated according to the Center of Disease Control and Prevention. The leisure-time activity scale and the International Physical Activity Questionnaire for Children-C (IPAQ-C) were used to assess physical activity level. Receives: Other: Descriptive questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index
Percentages were calculated with the CDC (Center of Disease Control and Prevention) BMI Percentage Calculator for Children and Adolescents.
Measured: 4 months
Sedentary time spent by children
Children's Leisure Time Activity Survey (CLASS)
Measured: 4 months
Physical activity levels of children
International Physical Activity Questionnaire for Children (IPAQ-C)
Measured: 4 months
Secondary outcomes (2)
Asthma control level
Asthma Control Test
Measured: 4 months
Demographic information questionnaire
The child was asked about demographic characteristics, asthma type, dietary habits, socioeconomic income level and number of meals; the mother was asked whether she used vitamin D during childhood and for how long; whether the child received breast milk and if so, for how many months; whether the mother had a smoking habit; and whether the mother had a urinary tract infection during pregnancy.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start23 Jan 2022
- Primary completion23 Mar 2022
- Study completion23 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozden Gokcek, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05918874
- Sponsor's protocol ID
- 2023/15
- Status last verified
- Jun 2023
- First submitted
- 15 Jun 2023
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sets generated and/or analyzed during the current study may be made available from the relevant principal investigator upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Postnatal Nutritional Status and Physical Activity Level in Obese Asthmatic Children
- ClinicalTrials.gov ID
- NCT05918874
- Acronym / sponsor ID
- 2023/15
- Conditions
- Obesity, Asthma in Children
- Keywords
- Childhood asthma, Obesity, Physical activity, Postnatal nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 23 Jan 2022 (actual)
- Primary completion
- 23 Mar 2022 (actual)
- Study completion
- 23 May 2022 (actual)
- First posted
- 26 Jun 2023 (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.
The aim of this study was to compare the duration of breast milk intake, vitamin D intake, asthma control level and physical activity levels between obese asthmatic children and non-obese children. This was a prospective study in children aged 8-17 years with asthma. Asthma control level was evaluated by asthma control test and physical activity level was evaluated by Physical Activity Questionnaire for Children (IPAQ-C) and leisure time activity scale.
Detailed description
Asthma and obesity, which are important public health problems and are common in childhood, are chronic diseases. The aim of this study was to compare breastfeeding duration, vitamin D intake, asthma control and physical activity levels between obese asthmatic children and non-obese children.
The study was a prospective study conducted in children aged 8-17 years with asthma. Demographic information of the children was recorded. Asthma control level was assessed by asthma control test and physical activity level was assessed by Physical Activity Questionnaire for Children (IPAQ-C) and leisure time activity scale.
It was conducted as a single-blind, prospective study in which the patients were randomized by simple randomization method as obese asthmatic children (experimental group) and non-obese asthmatic children (control group) according to the order of admission to the hospital.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| obese | – | Other: Descriptive questionnaireThe demographic characteristics of the children, type of asthma, dietary habits, socioeconomic income level and number of meals were asked to the child; the use of vitamin D in childhood and for how long, whether the child was breastfed or not, how many months the child was breastfed if breastfed, whether the mother had a smoking habit, and whether the mother had urinary tract infection during pregnancy were asked to the mother. Asthma control level was recorded according to the asthma control test. Body mass index was calculated according to the Center of Disease Control and Prevention. The leisure-time activity scale and the International Physical Activity Questionnaire for Children-C (IPAQ-C) were used to assess physical activity level. |
| non-obese | – | Other: Descriptive questionnaireThe demographic characteristics of the children, type of asthma, dietary habits, socioeconomic income level and number of meals were asked to the child; the use of vitamin D in childhood and for how long, whether the child was breastfed or not, how many months the child was breastfed if breastfed, whether the mother had a smoking habit, and whether the mother had urinary tract infection during pregnancy were asked to the mother. Asthma control level was recorded according to the asthma control test. Body mass index was calculated according to the Center of Disease Control and Prevention. The leisure-time activity scale and the International Physical Activity Questionnaire for Children-C (IPAQ-C) were used to assess physical activity level. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Volunteer children between the ages of 8-17 years with a diagnosis of asthma admitted to the Department of Pediatrics.
Key inclusion criteria (5 listed)
- diagnosed with asthma by a pediatrician,
- not in the attack process,
- no mental problems,
- do not have any systemic disease accompanying asthma (diabetes, etc.)
- children who voluntarily agreed to participate in the study
Key exclusion criteria (4 listed)
- severe posture disorders
- idiopathic scoliosis and idiopathic rheumatic disease
- history of orthopedic surgery
- children with mental retardation or a neurological problem
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 |
|---|---|---|
| Descriptive questionnaireQuestionnaires were administered to calculate whether the children were obese or not, to determine their asthma control levels, to determine their physical activity levels and to determine their leisure time activities. | Other | non-obese, obese |
Primary outcome
Body Mass Index
Time frame: 4 months
Percentages were calculated with the CDC (Center of Disease Control and Prevention) BMI Percentage Calculator for Children and Adolescents.
Sedentary time spent by children
Time frame: 4 months
Children's Leisure Time Activity Survey (CLASS)
Physical activity levels of children
Time frame: 4 months
International Physical Activity Questionnaire for Children (IPAQ-C)
2 secondary outcomes
Asthma control level
Time frame: 4 months
Demographic information questionnaire
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Individual participant dataSharing planned: Yes. Data sets generated and/or analyzed during the current study may be made available from the relevant principal investigator upon reasonable request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Asthma in Children, run by Ege University at 1 site in Turkey (Türkiye).
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 26 Jun 2023. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (time frame: 4 months). The study lists 3 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 26 Jun 2023.