School-based Multicomponent Intervention on Physical Fitness Related to Health and Body Image

March 21, 2016 updated by: Giseli Minatto, Santa Catarina Federal University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
568

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

  • Brazil
    • Santa Catarina
      • Florianópolis, Santa Catarina, Brazil, 88040900
        • Federal University of Santa Catarina

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

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

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: "MEXA-SE"
Intervention on physical fitness, eating habits and body image
Behavioral: "MEXA-SE"
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.
No Intervention: Control
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.
Experimental: "Espelho, espelho meu"
School-based intervention on body image
Behavioral: "Espelho, espelho meu"
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change on body mass index
Time Frame: Baseline, 14 weeks
Anthropometric measurements of body mass (kilograms), height (centimeters) to calculate body mass index (kilograms per square meter).
Baseline, 14 weeks
Change on skinfold thickness
Time Frame: Baseline, 14 weeks
Anthropometric measurements of skinfold thickness (millimeters) of biceps, triceps, subscapular, iliac crest and medial calf.
Baseline, 14 weeks
Change on flexibility
Time Frame: Baseline, 14 weeks
Modified Sit and Reach test (centimeters).
Baseline, 14 weeks
Change on muscular strength
Time Frame: Baseline, 14 weeks
Handgrip test measured by dynamometer (Kilograms).
Baseline, 14 weeks
Change on resistance levels
Time Frame: Baseline, 14 weeks
Modified abdominal test (number of repetitions).
Baseline, 14 weeks
Change on cardiorespiratory fitness
Time Frame: Baseline, 14 weeks
20-m shuttle run test (laps).
Baseline, 14 weeks
Change on body image
Time Frame: Baseline, 14 weeks
Self-perception (questionnaire).
Baseline, 14 weeks
Change on lipid
Time Frame: Baseline, 14 weeks
Enzymatic colorimetric test
Baseline, 14 weeks
Change on girth
Time Frame: Baseline, 14 weeks
Anthropometric measurements of girth (centimeters) of relaxed arm and waist.
Baseline, 14 weeks
Change on glucose profile
Time Frame: Baseline, 14 weeks
Enzymatic colorimetric test
Baseline, 14 weeks
Change on percent body fat
Time Frame: Baseline, 14 weeks
Measurement by bioelectrical impedance.
Baseline, 14 weeks
Change on fat free mass
Time Frame: Baseline, 14 weeks
Measurement by bioelectrical impedance.
Baseline, 14 weeks
Change on percent of water
Time Frame: Baseline, 14 weeks
Measurement by bioelectrical impedance.
Baseline, 14 weeks
Change on resistance
Time Frame: Baseline, 14 weeks
Measurement by bioelectrical impedance.
Baseline, 14 weeks
Change on reactance
Time Frame: Baseline, 14 weeks
Measurement by bioelectrical impedance.
Baseline, 14 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change on physical activity at school
Time Frame: Baseline, 14 weeks
ActiGraph accelerometers.
Baseline, 14 weeks
Change on leisure physical activity
Time Frame: Baseline, 14 weeks
List of physical activities practiced last week indicating the frequency and duration, commuting to school and preferred leisure activities reported in guided questionnaire.
Baseline, 14 weeks
Change on sedentary behaviour (television time)
Time Frame: Baseline, 14 weeks
Time in front of television during the week and over the weekend reported in guided questionnaire.
Baseline, 14 weeks
Change on sedentary behaviour (computer time)
Time Frame: Baseline, 14 weeks
Time in computer and / or video games during the week and over the weekend reported in guided questionnaire.
Baseline, 14 weeks
Change on blood pressure levels
Time Frame: Baseline, 14 weeks
Measured by Automatic blood pressure monitor.
Baseline, 14 weeks
Food consumption
Time Frame: Baseline, 14 weeks
Food consumption reported in guided questionnaire.
Baseline, 14 weeks
Food Knowledge
Time Frame: Baseline, 14 weeks
Knowledge consumption reported in guided questionnaire.
Baseline, 14 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Santa Catarina Federal University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Edio Luiz Petroski, Doctor, Federal University of Santa Catarina
  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 29, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MEXA-SE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

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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