Physical FitnessNCT02719704

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

A study testing "MEXA-SE" and "Espelho, espelho meu" in people with Physical Fitness and Body Image, run by Santa Catarina Federal University at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 10 to 18 yearsHealthy volunteers can take part
Conditions the study is for: Physical Fitness, Body Image
What is being tested?: "MEXA-SE" and "Espelho, espelho meu"
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 568 participants
Where: 1 siteBrazil
Study dates: Mar 2015to Jul 2015
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 10 to 18 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

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

Who cannot join

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;

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Federal University of Santa Catarina
Florianópolis, Santa Catarina, 88040900

Other trials in Brazil

About this study

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

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.

Conditions: Physical Fitness, Body Image
Being tested: "MEXA-SE", "Espelho, espelho meu"

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

"MEXA-SE"Behavioural
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.
"Espelho, espelho meu"Behavioural
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.

Study groups in NCT02719704
Study group	Role	What they receive
"MEXA-SE"	Experimental	Intervention on physical fitness, eating habits and body image Receives: 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 Receives: Behavioral: "Espelho, espelho meu"

What is being measured

The primary outcome is the main question the study is designed to answer.

Change on body mass index
Anthropometric measurements of body mass (kilograms), height (centimeters) to calculate body mass index (kilograms per square meter).
Measured: Baseline, 14 weeks
Change on skinfold thickness
Anthropometric measurements of skinfold thickness (millimeters) of biceps, triceps, subscapular, iliac crest and medial calf.
Measured: Baseline, 14 weeks
Change on flexibility
Modified Sit and Reach test (centimeters).
Measured: Baseline, 14 weeks
Change on muscular strength
Handgrip test measured by dynamometer (Kilograms).
Measured: Baseline, 14 weeks
Change on resistance levels
Modified abdominal test (number of repetitions).
Measured: Baseline, 14 weeks
Change on cardiorespiratory fitness
20-m shuttle run test (laps).
Measured: Baseline, 14 weeks
Change on body image
Self-perception (questionnaire).
Measured: Baseline, 14 weeks
Change on lipid
Enzymatic colorimetric test
Measured: Baseline, 14 weeks
Change on girth
Anthropometric measurements of girth (centimeters) of relaxed arm and waist.
Measured: Baseline, 14 weeks
Change on glucose profile
Enzymatic colorimetric test
Measured: Baseline, 14 weeks
Change on percent body fat
Measurement by bioelectrical impedance.
Measured: Baseline, 14 weeks
Change on fat free mass
Measurement by bioelectrical impedance.
Measured: Baseline, 14 weeks
Change on percent of water
Measurement by bioelectrical impedance.
Measured: Baseline, 14 weeks
Change on resistance
Measurement by bioelectrical impedance.
Measured: Baseline, 14 weeks
Change on reactance
Measurement by bioelectrical impedance.
Measured: Baseline, 14 weeks

Secondary outcomes (7)

Change on physical activity at school
ActiGraph accelerometers.
Measured: Baseline, 14 weeks
Change on leisure physical activity
List of physical activities practiced last week indicating the frequency and duration, commuting to school and preferred leisure activities reported in guided questionnaire.
Measured: Baseline, 14 weeks
Change on sedentary behaviour (television time)
Time in front of television during the week and over the weekend reported in guided questionnaire.
Measured: Baseline, 14 weeks
Change on sedentary behaviour (computer time)
Time in computer and / or video games during the week and over the weekend reported in guided questionnaire.
Measured: Baseline, 14 weeks
Change on blood pressure levels
Measured by Automatic blood pressure monitor.
Measured: Baseline, 14 weeks
Food consumption
Food consumption reported in guided questionnaire.
Measured: Baseline, 14 weeks
Food Knowledge
Knowledge consumption reported in guided questionnaire.
Measured: Baseline, 14 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2015Jul 2015

First posted25 Mar 2016 (estimated)
Study startMar 2015
Primary completionJul 2015
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Physical FitnessStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 568 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02719704
Sponsor's protocol ID: MEXA-SE
Status last verified: Mar 2016
First submitted: 29 Feb 2016
Last updated: 25 Mar 2016
Results posted: No
Data monitoring committee: Yes
Individual data sharing: Yes

Publications

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.
PubMed 31991158

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Yoga vs. Stretching-Strengthening: Physical Fitness in Sedentary Young Adults
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Integrating Sport-Specific Comprehensive Training to Upscale Performance in Women and Girls
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All Physical Fitness trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02719704
Acronym / sponsor ID: MEXA-SE
Conditions: Physical Fitness, Body Image
Study type: Interventional
Recruitment status: Completed
Enrolment: 568 participants (actual)
Lead sponsor: Santa Catarina Federal UniversityUniversity, hospital or other
Study start: Mar 2015
Primary completion: Jul 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 25 Mar 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
"MEXA-SE"	Experimental	Behavioral: "MEXA-SE"Intervention on physical fitness, eating habits and body image
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	Behavioral: "Espelho, espelho meu"School-based intervention on body image

Who may qualify

Ages: 10 to 18 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (5 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
"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.	Behavioural	"MEXA-SE"
"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.	Behavioural	"Espelho, espelho meu"

Primary outcome

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).
Change on skinfold thickness
Time frame: Baseline, 14 weeks
Anthropometric measurements of skinfold thickness (millimeters) of biceps, triceps, subscapular, iliac crest and medial calf.
Change on flexibility
Time frame: Baseline, 14 weeks
Modified Sit and Reach test (centimeters).
Change on muscular strength
Time frame: Baseline, 14 weeks
Handgrip test measured by dynamometer (Kilograms).
Change on resistance levels
Time frame: Baseline, 14 weeks
Modified abdominal test (number of repetitions).
Change on cardiorespiratory fitness
Time frame: Baseline, 14 weeks
20-m shuttle run test (laps).
Change on body image
Time frame: Baseline, 14 weeks
Self-perception (questionnaire).
Change on lipid
Time frame: Baseline, 14 weeks
Enzymatic colorimetric test
Change on girth
Time frame: Baseline, 14 weeks
Anthropometric measurements of girth (centimeters) of relaxed arm and waist.
Change on glucose profile
Time frame: Baseline, 14 weeks
Enzymatic colorimetric test
Change on percent body fat
Time frame: Baseline, 14 weeks
Measurement by bioelectrical impedance.
Change on fat free mass
Time frame: Baseline, 14 weeks
Measurement by bioelectrical impedance.
Change on percent of water
Time frame: Baseline, 14 weeks
Measurement by bioelectrical impedance.
Change on resistance
Time frame: Baseline, 14 weeks
Measurement by bioelectrical impedance.
Change on reactance
Time frame: Baseline, 14 weeks
Measurement by bioelectrical impedance.

7 secondary outcomes

Change on physical activity at school
Time frame: Baseline, 14 weeks
Change on leisure physical activity
Time frame: Baseline, 14 weeks
Change on sedentary behaviour (television time)
Time frame: Baseline, 14 weeks
Change on sedentary behaviour (computer time)
Time frame: Baseline, 14 weeks
Change on blood pressure levels
Time frame: Baseline, 14 weeks
Food consumption
Time frame: Baseline, 14 weeks
Food Knowledge
Time frame: Baseline, 14 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2016.
Derived from this study: PubMed 31991158Martins 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.
Individual participant dataSharing planned: Yes

Related trials for Physical Fitness

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
Recruiting
Yoga vs. Stretching-Strengthening: Physical Fitness in Sedentary Young Adults
Sedentary Lifestlye, Exercise
Not yet recruiting
Integrating Sport-Specific Comprehensive Training to Upscale Performance in Women and Girls
Sport Injuries, Performance in Sport
Enrolling by invitationObservational study
Trajectory Study: Predicting Cardiometabolic Health in Adolescents and Young Adults Based on Childhood Fitness, Sleep, and Diet
Cardiometabolic Health

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Edio Luiz Petroski, Doctor study director

Federal University of Santa Catarina

Cilene Rebolho Martins, PhD Student principal investigator

Federal University of Santa Catarina

Juliane Berria, PhD Student principal investigator

Federal University of Santa Catarina

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing "MEXA-SE" and "Espelho, espelho meu" in people with Physical Fitness and Body Image, run by Santa Catarina Federal University at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change on body mass index (time frame: Baseline, 14 weeks). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02719704, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2016.