- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02719704
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
568
Phase
- 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
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Santa Catarina
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Florianópolis, Santa Catarina, Brazil, 88040900
- Federal University of Santa Catarina
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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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: "MEXA-SE"
Intervention on physical fitness, eating habits and body image
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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.
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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.
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Experimental: "Espelho, espelho meu"
School-based intervention on body image
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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.
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What is the study measuring?
Primary Outcome Measures
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).
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Baseline, 14 weeks
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Change on skinfold thickness
Time Frame: Baseline, 14 weeks
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Anthropometric measurements of skinfold thickness (millimeters) of biceps, triceps, subscapular, iliac crest and medial calf.
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Baseline, 14 weeks
|
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Change on flexibility
Time Frame: Baseline, 14 weeks
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Modified Sit and Reach test (centimeters).
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Baseline, 14 weeks
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Change on muscular strength
Time Frame: Baseline, 14 weeks
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Handgrip test measured by dynamometer (Kilograms).
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Baseline, 14 weeks
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Change on resistance levels
Time Frame: Baseline, 14 weeks
|
Modified abdominal test (number of repetitions).
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Baseline, 14 weeks
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Change on cardiorespiratory fitness
Time Frame: Baseline, 14 weeks
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20-m shuttle run test (laps).
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Baseline, 14 weeks
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Change on body image
Time Frame: Baseline, 14 weeks
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Self-perception (questionnaire).
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Baseline, 14 weeks
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Change on lipid
Time Frame: Baseline, 14 weeks
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Enzymatic colorimetric test
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Baseline, 14 weeks
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Change on girth
Time Frame: Baseline, 14 weeks
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Anthropometric measurements of girth (centimeters) of relaxed arm and waist.
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Baseline, 14 weeks
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Change on glucose profile
Time Frame: Baseline, 14 weeks
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Enzymatic colorimetric test
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Baseline, 14 weeks
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Change on percent body fat
Time Frame: Baseline, 14 weeks
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Measurement by bioelectrical impedance.
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Baseline, 14 weeks
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Change on fat free mass
Time Frame: Baseline, 14 weeks
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Measurement by bioelectrical impedance.
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Baseline, 14 weeks
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Change on percent of water
Time Frame: Baseline, 14 weeks
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Measurement by bioelectrical impedance.
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Baseline, 14 weeks
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Change on resistance
Time Frame: Baseline, 14 weeks
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Measurement by bioelectrical impedance.
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Baseline, 14 weeks
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Change on reactance
Time Frame: Baseline, 14 weeks
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Measurement by bioelectrical impedance.
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Baseline, 14 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change on physical activity at school
Time Frame: Baseline, 14 weeks
|
ActiGraph accelerometers.
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Baseline, 14 weeks
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Change on leisure physical activity
Time Frame: Baseline, 14 weeks
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List of physical activities practiced last week indicating the frequency and duration, commuting to school and preferred leisure activities reported in guided questionnaire.
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Baseline, 14 weeks
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Change on sedentary behaviour (television time)
Time Frame: Baseline, 14 weeks
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Time in front of television during the week and over the weekend reported in guided questionnaire.
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Baseline, 14 weeks
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Change on sedentary behaviour (computer time)
Time Frame: Baseline, 14 weeks
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Time in computer and / or video games during the week and over the weekend reported in guided questionnaire.
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Baseline, 14 weeks
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Change on blood pressure levels
Time Frame: Baseline, 14 weeks
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Measured by Automatic blood pressure monitor.
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Baseline, 14 weeks
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Food consumption
Time Frame: Baseline, 14 weeks
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Food consumption reported in guided questionnaire.
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Baseline, 14 weeks
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Food Knowledge
Time Frame: Baseline, 14 weeks
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Knowledge consumption reported in guided questionnaire.
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Baseline, 14 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- 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.
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
March 1, 2015
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
February 29, 2016
First Submitted That Met QC Criteria
March 21, 2016
First Posted (Estimate)
March 25, 2016
Study Record Updates
Last Update Posted (Estimate)
March 25, 2016
Last Update Submitted That Met QC Criteria
March 21, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Other Study ID 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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