- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05918874
Postnatal Nutrition and Physical Activity in Obese Asthmatic Children
Evaluation of Postnatal Nutritional Status and Physical Activity Level in Obese Asthmatic Children
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Karsıyaka
-
İzmir, Karsıyaka, Turkey, 35575
- Ege University Faculty of Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- severe posture disorders
- idiopathic scoliosis and idiopathic rheumatic disease
- history of orthopedic surgery
- children with mental retardation or a neurological problem
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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. |
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.
|
|
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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
4 months
|
|
Sedentary time spent by children
Time Frame: 4 months
|
Children's Leisure Time Activity Survey (CLASS)
|
4 months
|
|
Physical activity levels of children
Time Frame: 4 months
|
International Physical Activity Questionnaire for Children (IPAQ-C)
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Asthma control level
Time Frame: 4 months
|
Asthma Control Test
|
4 months
|
|
Demographic information questionnaire
Time Frame: 4 months
|
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.
|
4 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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