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Effect of a Multicomponent Intervention in Children and Adolescents

NCT02929472 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2016-10-11

No results posted yet for this study

Summary

The aim of this study was: to evaluate the effectiveness of a multicomponent pilot intervention in improving physical fitness (PF) and metabolic risk markers in children and adolescents; and examine if possible changes in PF are associated with metabolic risk markers in children and adolescents exposed to intervention. For such, a multicomponent pilot intervention was performed, consisting of sessions of physical exercise and nutrition education.The study included 35 children and adolescents (ages 7-13) divided into two groups: a intervention group (INT, n = 17) and a control one (CONT, n = 18). The sample underwent two moments of data collection (T0 and T1). The 1-hour exercise sessions were held based on an intensity above 65% of maximum HR. To assess the metabolic risk markers, analyzes of total cholesterol, HDL-C fraction, LDL-c fraction, triglycerides, blood glucose, insulin, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) were conducted in T0 and T1. Physical activity (PA) was assessed by accelerometry (Actigraph, GT3-X model, Florida) for 10 consecutive days. The health related PF components were evaluated throw different tests 20m Shuttle-run Test; handgrip dynamometry (TKK 5101 tightening D; Tokyo Japan); standing feet jump Test; Abdominal Test; trunk extension test; and body mass index (BMI) was calculated. Motor fitness was assessed by coordinations Test für Kinder - KTK. To assess food consumption, a 24-hour recall was held. For statistical analysis, the t-Student test and General Linear Model (GLM) - ANCOVA for repeated measures test with post-hoc Bonferroni (p \<0.05) were performed. Multilinear regressions were done to analyse associations between measured outcomes.

Conditions

Interventions

BEHAVIORAL

Physical exercise

The intervention group (INT, n = 17, 7 boys) who attended at least 75% of PA classes and met more than 50% of food goals.The exercise sessions took 90 minutes, in order to assure at least 60 minutes of physical exercise, during 12 weeks. The sessions were always taught by the same staff, and were composed of: 10 minutes of warm-up; 30 minutes of circuit training; 15-minute of pre-sports and recreational games;and 5 minutes resting activities.

BEHAVIORAL

without physical exercise

The control one (CONT, n = 18, 6 boys), with a minimum or less than 49% attendance in PA classes, and were not involved in the nutrition education program.

Sponsors & Collaborators

  • Clarice Maria de Lucena Martins

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2015-06-30
Completion
2015-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02929472 on ClinicalTrials.gov