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Trial registered on ANZCTR


Registration number
ACTRN12617001063303
Ethics application status
Approved
Date submitted
25/05/2017
Date registered
21/07/2017
Date last updated
21/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Influence of overweight or obesity on the dynamic balance in 2nd cycle students of Portuguese elementary school
Scientific title
Influence of childhood obesity on dynamic balance in 2nd cycle students of Portuguese elementary school
Secondary ID [1] 292048 0
None
Universal Trial Number (UTN)
U1111-1196-7979
Trial acronym
IofCOonDBin2ndCSofPES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood Obesity 303448 0
Dynamic balance 303449 0
Condition category
Condition code
Physical Medicine / Rehabilitation 302856 302856 0 0
Physiotherapy
Diet and Nutrition 302857 302857 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an observational study aimed to understand the incidence of obesity in schoolchildren by 5th and 6th school grade students from both gender of the School Group Infante D. Henriques from Viseu, as well as the possible relation with the balance.
This 5th and 6th grade population was chosen according to two different school periods, the entrance and exiting level for the twice Basic Education Cycle, This study have taken one month from participant selection process, personal identification questionnaire fill, in order to assess body weight, a Body mass index (BMI) was conducted. Each student completes a single assessment session of approximately 30 minutes. BMI was calculated and the subjects were classified as follows: obesity, overweight, normal weight and thinness according to the proposed limits. This dues to our intent of seeing if there was already possible to compare children with BMI above ideal with children with ideal BMI in order to understand the influence of BMI and dynamic postural balance. The Star Excursion Balance Test (SEBT), which is a measure of dynamic postural control, and has been chosen because it is a reliable test that evaluates dynamic stability in different planes because it is economical and validated..
The test was performed in the school gymnasium, where adhesive was applied to the soil in order to perform a star in which its segments were about 120 cm long and arranged at 45° between them, arranged with the help of the goniometer.
The children were instructed that they should engage in the interception of the ribbons (being the center), so that later they would only have one foot placed in it so that with the other foot they tried to reach as far as possible the 8 segments in the following Order: Anterior, Posterior, Lateral; Medial, Anterolateral, Posterior-medial, Antero-medial, Posterior-Lateral.
To facilitate children’s understanding, they were told that they should reach as far as possible the 8 vectors in the following order: North, South, East, West, Northeast, Southwest, Northwest, Southeast, and were also given the opportunity to experience the Before measurements are taken. The children performed the test and the measurements of the amplitudes reached by both lower limbs were taken for comparison.
Intervention code [1] 298176 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302251 0
Analysis a Body mass index (BMI, assessed by stadiometer and digital scales) was conducted (Viester, et al., 2013; Desouzart, Filgueiras, Matos, & Marques, 2016), in order to assess body weight,
Timepoint [1] 302251 0
Initial evaluation
Primary outcome [2] 302749 0
Analysis a dynamic balance through Star Excursion Balance Test (SEBT) (Bicici, Karatas, & Baltaci, 2012).
Timepoint [2] 302749 0
Initial evaluation
Secondary outcome [1] 335299 0
Correlation between Body mass index (BMI, assessed by stadiometer and digital scales) and dynamic balance through Star Excursion Balance Test (SEBT) (Bicici, Karatas, & Baltaci, 2012).
Timepoint [1] 335299 0
At baseline

Eligibility
Key inclusion criteria
i] to be aged between 10 and 11 years; ii] understand the aims of the study and agree to participate voluntarily; iii] the provision of informed consent by students’ parents and guardians
Minimum age
10 Years
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
i] Presence of pathology a known health condition of rheumatological, orthopedic, cardio-respiratory, oncological pathology and / or diagnosed coronary disease

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The children performed the test and the measurements of the amplitudes reached by both lower limbs were taken for comparison.
It is relevant to note that in the test any repetition was discarded if the child moved the supporting leg from the center of the figure, was unable to maintain balance in the supporting leg during the test and deviated from the segment being evaluated.
As for the measurements, these were removed with a tape measure after the child placed the test foot and always the interception of the vectors (center) to the distal end of the hallux.
In order to know whether there are actually changes in balance, the method of Olmsted, Carcia, Hertel & Shultz (2002), which defines that in order to conclude if there is an osteoarticular imbalance, is necessary to have a difference of 4 centimeters of amplitude in the same segment between both Member States
SPSS, 23.0 version was used in order to treat all the statistical data. Descriptive statistics were performed, considering all the variables obtained. Due to the small number of the sample and to facilitate the analysis, the variables of BMI were grouped, and we considered four groups: obesity, overweight, normal weight and thinness. The statistically level of significance was establish in p = 0.05.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
Actual
1/07/2015
Date of last participant enrolment
Anticipated
Actual
15/07/2015
Date of last data collection
Anticipated
Actual
31/07/2015
Sample size
Target
314
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 8919 0
Portugal
State/province [1] 8919 0
Viseu

Funding & Sponsors
Funding source category [1] 296582 0
University
Name [1] 296582 0
Piaget Institute of Viseu
Country [1] 296582 0
Portugal
Primary sponsor type
University
Name
Piaget Institute of Viseu
Address
Campus Universitário de Viseu
Estrada do Alto do Gaio
3515-776 Galifonge, Lordosa – Viseu
Country
Portugal
Secondary sponsor category [1] 295536 0
None
Name [1] 295536 0
None
Address [1] 295536 0
None
Country [1] 295536 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297805 0
ethical committee of Piaget Institute
Ethics committee address [1] 297805 0
Ethics committee country [1] 297805 0
Portugal
Date submitted for ethics approval [1] 297805 0
03/03/2015
Approval date [1] 297805 0
21/04/2015
Ethics approval number [1] 297805 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75146 0
Prof Gustavo Desouzart
Address 75146 0
Campus Universitário de Viseu
Estrada do Alto do Gaio
3515-776 Galifonge, Lordosa – Viseu
Country 75146 0
Portugal
Phone 75146 0
+351 232 910 100
Fax 75146 0
+351 232 910 189
Email 75146 0
[email protected]
Contact person for public queries
Name 75147 0
Gustavo Desouzart
Address 75147 0
Campus Universitário de Viseu
Estrada do Alto do Gaio
3515-776 Galifonge, Lordosa – Viseu
Country 75147 0
Portugal
Phone 75147 0
+351 232 910 100
Fax 75147 0
+351 232 910 189
Email 75147 0
[email protected]
Contact person for scientific queries
Name 75148 0
Gustavo Desouzart
Address 75148 0
Campus Universitário de Viseu
Estrada do Alto do Gaio
3515-776 Galifonge, Lordosa – Viseu
Country 75148 0
Portugal
Phone 75148 0
+351 232 910 100
Fax 75148 0
+351 232 910 189
Email 75148 0
[email protected]

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