Postnatal Nutrition and Physical Activity in Obese Asthmatic Children

June 15, 2023 updated by: Ozden Gokcek, Ege University

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.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

24

Contacts and Locations

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

Study Locations

    • Karsıyaka
      • İzmir, Karsıyaka, Turkey, 35575
        • Ege University Faculty of Health Sciences

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

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Volunteer children between the ages of 8-17 years with a diagnosis of asthma admitted to the Department of Pediatrics.

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

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

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

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

Sponsor

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)

January 23, 2022

Primary Completion (Actual)

March 23, 2022

Study Completion (Actual)

May 23, 2022

Study Registration Dates

First Submitted

June 15, 2023

First Submitted That Met QC Criteria

June 15, 2023

First Posted (Actual)

June 26, 2023

Study Record Updates

Last Update Posted (Actual)

June 26, 2023

Last Update Submitted That Met QC Criteria

June 15, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data sets generated and/or analyzed during the current study may be made available from the relevant principal investigator upon reasonable request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

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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