NCT02719704

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
568

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 29, 2016

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 25, 2016

Completed
Last Updated

March 25, 2016

Status Verified

March 1, 2016

Enrollment Period

4 months

First QC Date

February 29, 2016

Last Update Submit

March 21, 2016

Conditions

Outcome Measures

Primary Outcomes (15)

  • Change on body mass index

    Anthropometric measurements of body mass (kilograms), height (centimeters) to calculate body mass index (kilograms per square meter).

    Baseline, 14 weeks

  • Change on skinfold thickness

    Anthropometric measurements of skinfold thickness (millimeters) of biceps, triceps, subscapular, iliac crest and medial calf.

    Baseline, 14 weeks

  • Change on flexibility

    Modified Sit and Reach test (centimeters).

    Baseline, 14 weeks

  • Change on muscular strength

    Handgrip test measured by dynamometer (Kilograms).

    Baseline, 14 weeks

  • Change on resistance levels

    Modified abdominal test (number of repetitions).

    Baseline, 14 weeks

  • Change on cardiorespiratory fitness

    20-m shuttle run test (laps).

    Baseline, 14 weeks

  • Change on body image

    Self-perception (questionnaire).

    Baseline, 14 weeks

  • Change on lipid

    Enzymatic colorimetric test

    Baseline, 14 weeks

  • Change on girth

    Anthropometric measurements of girth (centimeters) of relaxed arm and waist.

    Baseline, 14 weeks

  • Change on glucose profile

    Enzymatic colorimetric test

    Baseline, 14 weeks

  • Change on percent body fat

    Measurement by bioelectrical impedance.

    Baseline, 14 weeks

  • Change on fat free mass

    Measurement by bioelectrical impedance.

    Baseline, 14 weeks

  • Change on percent of water

    Measurement by bioelectrical impedance.

    Baseline, 14 weeks

  • Change on resistance

    Measurement by bioelectrical impedance.

    Baseline, 14 weeks

  • Change on reactance

    Measurement by bioelectrical impedance.

    Baseline, 14 weeks

Secondary Outcomes (7)

  • Change on physical activity at school

    Baseline, 14 weeks

  • Change on leisure physical activity

    Baseline, 14 weeks

  • Change on sedentary behaviour (television time)

    Baseline, 14 weeks

  • Change on sedentary behaviour (computer time)

    Baseline, 14 weeks

  • Change on blood pressure levels

    Baseline, 14 weeks

  • +2 more secondary outcomes

Study Arms (3)

"MEXA-SE"

EXPERIMENTAL

Intervention on physical fitness, eating habits and body image

Behavioral: "MEXA-SE"

Control

NO INTERVENTION

School of the control group carried out one semester with the regular and traditional activities. The control school had three physical educations lessons per week, similar of experimental schools.

"Espelho, espelho meu"

EXPERIMENTAL

School-based intervention on body image

Behavioral: "Espelho, espelho meu"

Interventions

"MEXA-SE"BEHAVIORAL

MEXA-SE (move yourself) was structured into three main components: A) Physical fitness: The first component was to increase time in moderate to vigorous physical activity during Physical Education lessons. There were also prompts to help students to engage in increased physical activity during school recess; B) Eating habits: The second component consisted of six sessions (45 minutes per session) designed to promote reflection and positive changes in eating habits and health care (to improve knowledge and eating habits), conducted by nutritionist; C) Body image: The third component was composed of 3 sessions (45 minutes per session) focused on body image satisfaction ("Espelho, espelho meu": School based Intervention) conducted by Physical Education researcher.

"MEXA-SE"

Behavioral: "Espelho, espelho meu": School based intervention on body image. Body image is worked in four 45 minutes sessions, conducted with a frequency of once a week by a researcher. The topics covered in these sessions refer to: Beauty Standards (media influence and formation of body image), individual qualities (individual and classmates qualities) and selfesteem. These meetings will be held through video, lecture, dynamics, photo sessions and preparation of posters.

"Espelho, espelho meu"

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Santa Catarina

Florianópolis, Santa Catarina, 88040900, Brazil

Location

Related Publications (1)

  • 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.

Study Officials

  • Edio Luiz Petroski, Doctor

    Federal University of Santa Catarina

    STUDY DIRECTOR
  • Cilene Rebolho Martins, PhD Student

    Federal University of Santa Catarina

    PRINCIPAL INVESTIGATOR
  • Juliane Berria, PhD Student

    Federal University of Santa Catarina

    PRINCIPAL INVESTIGATOR
  • Giseli Minatto, PhD Student

    Federal University of Santa Catarina

    PRINCIPAL INVESTIGATOR
  • Luiz R. A. de Lima, PhD Student

    Federal University of Santa Catarina

    PRINCIPAL INVESTIGATOR
  • Jéssika A. J. Vieira, Master Degree Student

    Federal University of Santa Catarina

    PRINCIPAL INVESTIGATOR
  • André Machado, Master Degree Student

    Federal University of Santa Catarina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

February 29, 2016

First Posted

March 25, 2016

Study Start

March 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

March 25, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will share

Locations