Clinical trial NCT02719704: School-based Multicomponent Intervention on Physical Fitness Related to Health and Body Image
Official title: Effect of a Multicomponent Intervention Program on Physical Fitness Related to Health and Body Image: School-based Study With Adolescents of Florianópolis, Santa Catarina, Brazil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Fitness
Body Image
Lead sponsor: Santa Catarina Federal University
Sponsor class: OTHER
First posted: 2016-03-25
Enrollment: 568
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main purpose of this study is to analyse the effect of a multicomponent intervention, applied during one scholar semester, on body composition, strength, flexibility, cardiorespiratory fitness, lipid and metabolic profile, and body image of students from sixth to ninth grade. This is a non-randomized controlled design. Approximately 568 schoolchildren of grades sixth through ninth were recruited from 2 public secondary schools in Florianópolis, Brazil. The main component of the intervention entitled "MEXA-SE" (move yourself) consisted of the implementation of three physical education classes per week with aerobic exercises, strength and flexibility activities. In addition, play activities in school recess, and educational activities on physical activity, sedentary behaviour, eating habits and body image were performed. Data collection was performed before and immediately after 14 weeks of intervention. The primary outcomes included the body composition, strength, flexibility, cardiorespiratory fitness, lipid and metabolic profile, and body image. Other variables included were: physical activity level, sedentary behaviour, and blood pressure level. Other components of the lifestyle (e.g., eating habits), psychological (e.g., self-rated health) also were evaluated in the participants. Descriptive analysis, two-way ANOVA for mixed models and ANCOVA will be applied for within and between comparison groups, if the premises of this test are met. The level of significance for the study was 5% for two-tailed tests.


Eligibility criteria: Inclusion Criteria:

* Students volunteering as participation;
* Students regularly enrolled from the 6th to the 9th grades in the Florianópolis municipal school system.

Exclusion Criteria:

* Students of other grades;
* Students who dropout of school;
* Students with incomplete data at baseline and end 14 weeks;
* Students who are absence in the school days of data collection;
* Students who refused to participate in data collection or intervention;

Primary outcomes:
measure: Change on body mass index
timeFrame: Baseline, 14 weeks
measure: Change on skinfold thickness
timeFrame: Baseline, 14 weeks
measure: Change on flexibility
timeFrame: Baseline, 14 weeks
measure: Change on muscular strength
timeFrame: Baseline, 14 weeks
measure: Change on resistance levels
timeFrame: Baseline, 14 weeks
measure: Change on cardiorespiratory fitness
timeFrame: Baseline, 14 weeks
measure: Change on body image
timeFrame: Baseline, 14 weeks
measure: Change on lipid
timeFrame: Baseline, 14 weeks
measure: Change on girth
timeFrame: Baseline, 14 weeks
measure: Change on glucose profile
timeFrame: Baseline, 14 weeks
measure: Change on percent body fat
timeFrame: Baseline, 14 weeks
measure: Change on fat free mass
timeFrame: Baseline, 14 weeks
measure: Change on percent of water
timeFrame: Baseline, 14 weeks
measure: Change on resistance
timeFrame: Baseline, 14 weeks
measure: Change on reactance
timeFrame: Baseline, 14 weeks
Secondary outcomes:
measure: Change on physical activity at school
timeFrame: Baseline, 14 weeks
measure: Change on leisure physical activity
timeFrame: Baseline, 14 weeks
measure: Change on sedentary behaviour (television time)
timeFrame: Baseline, 14 weeks
measure: Change on sedentary behaviour (computer time)
timeFrame: Baseline, 14 weeks
measure: Change on blood pressure levels
timeFrame: Baseline, 14 weeks
measure: Food consumption
timeFrame: Baseline, 14 weeks
measure: Food Knowledge
timeFrame: Baseline, 14 weeks
Other outcomes:
Locations:
city: Florianópolis
country: Brazil
facility: Federal University of Santa Catarina
state: Santa Catarina
Study officials:
affiliation: Federal University of Santa Catarina
name: Edio Luiz Petroski, Doctor
role: STUDY_DIRECTOR
affiliation: Federal University of Santa Catarina
name: Cilene Rebolho Martins, PhD Student
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Santa Catarina
name: Juliane Berria, PhD Student
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Santa Catarina
name: Giseli Minatto, PhD Student
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Santa Catarina
name: Luiz R. A. de Lima, PhD Student
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Santa Catarina
name: Jéssika A. J. Vieira, Master Degree Student
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Santa Catarina
name: André Machado, Master Degree Student
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martins PC, de Lima LRA, Berria J, Petroski EL, da Silva AM, Silva DAS. Association between phase angle and isolated and grouped physical fitness indicators in adolescents. Physiol Behav. 2020 Apr 1;217:112825. doi: 10.1016/j.physbeh.2020.112825. Epub 2020 Jan 25.