Postnatal Nutrition and Physical Activity in Obese Asthmatic Children

Sponsor

Ege University (Other)

Overall Status

Completed

CT.gov ID

NCT05918874

Collaborator

(none)

Enrollment

Location

3.9

Actual Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Asthma in Children	Other: Descriptive questionnaire

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

Study Type:

Observational

Actual Enrollment :

24 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Evaluation of Postnatal Nutritional Status and Physical Activity Level in Obese Asthmatic Children

Actual Study Start Date :

Jan 23, 2022

Actual Primary Completion Date :

Mar 23, 2022

Actual Study Completion Date :

May 23, 2022

Arms and Interventions

Arm	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.	Other: Descriptive questionnaire 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.	Other: Descriptive questionnaire 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.

Arm

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.

Other: Descriptive questionnaire

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

Other: Descriptive questionnaire

Outcome Measures

Primary Outcome Measures

Body Mass Index [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 [4 months]
Children's Leisure Time Activity Survey (CLASS)
Physical activity levels of children [4 months]
International Physical Activity Questionnaire for Children (IPAQ-C)

Secondary Outcome Measures

Asthma control level [4 months]
Asthma Control Test
Demographic information questionnaire [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ege university faculty of health sciences	İzmir	Karsıyaka	Turkey	35575

Sponsors and Collaborators

Ege University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ozden Gokcek, Principal Investigator, Ege University

ClinicalTrials.gov Identifier:

NCT05918874

Other Study ID Numbers:

2023/15

First Posted:

Jun 26, 2023

Last Update Posted:

Jun 26, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ozden Gokcek, Principal Investigator, Ege University

Additional relevant MeSH terms:

Asthma

Obesity

Study Results

No Results Posted as of Jun 26, 2023