Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02719704
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02719704
Recruitment Status : Completed
First Posted : March 25, 2016
Last Update Posted : March 25, 2016
Sponsor:
Information provided by (Responsible Party):
Giseli Minatto, Universidade Federal de Santa Catarina

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.

Condition or disease Intervention/treatment Phase
Physical Fitness Body Image Behavioral: "MEXA-SE" Behavioral: "Espelho, espelho meu" Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 568 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : March 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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).

  2. Change on skinfold thickness [ Time Frame: Baseline, 14 weeks ]
    Anthropometric measurements of skinfold thickness (millimeters) of biceps, triceps, subscapular, iliac crest and medial calf.

  3. Change on flexibility [ Time Frame: Baseline, 14 weeks ]
    Modified Sit and Reach test (centimeters).

  4. Change on muscular strength [ Time Frame: Baseline, 14 weeks ]
    Handgrip test measured by dynamometer (Kilograms).

  5. Change on resistance levels [ Time Frame: Baseline, 14 weeks ]
    Modified abdominal test (number of repetitions).

  6. Change on cardiorespiratory fitness [ Time Frame: Baseline, 14 weeks ]
    20-m shuttle run test (laps).

  7. Change on body image [ Time Frame: Baseline, 14 weeks ]
    Self-perception (questionnaire).

  8. Change on lipid [ Time Frame: Baseline, 14 weeks ]
    Enzymatic colorimetric test

  9. Change on girth [ Time Frame: Baseline, 14 weeks ]
    Anthropometric measurements of girth (centimeters) of relaxed arm and waist.

  10. Change on glucose profile [ Time Frame: Baseline, 14 weeks ]
    Enzymatic colorimetric test

  11. Change on percent body fat [ Time Frame: Baseline, 14 weeks ]
    Measurement by bioelectrical impedance.

  12. Change on fat free mass [ Time Frame: Baseline, 14 weeks ]
    Measurement by bioelectrical impedance.

  13. Change on percent of water [ Time Frame: Baseline, 14 weeks ]
    Measurement by bioelectrical impedance.

  14. Change on resistance [ Time Frame: Baseline, 14 weeks ]
    Measurement by bioelectrical impedance.

  15. Change on reactance [ Time Frame: Baseline, 14 weeks ]
    Measurement by bioelectrical impedance.


Secondary Outcome Measures :
  1. Change on physical activity at school [ Time Frame: Baseline, 14 weeks ]
    ActiGraph accelerometers.

  2. 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.

  3. 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.

  4. 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.

  5. Change on blood pressure levels [ Time Frame: Baseline, 14 weeks ]
    Measured by Automatic blood pressure monitor.

  6. Food consumption [ Time Frame: Baseline, 14 weeks ]
    Food consumption reported in guided questionnaire.

  7. Food Knowledge [ Time Frame: Baseline, 14 weeks ]
    Knowledge consumption reported in guided questionnaire.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02719704


Locations
Layout table for location information
Brazil
Federal University of Santa Catarina
Florianópolis, Santa Catarina, Brazil, 88040900
Sponsors and Collaborators
Santa Catarina Federal University
Investigators
Layout table for investigator information
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

Layout table for additonal information
Responsible Party: Giseli Minatto, PhD Student, Universidade Federal de Santa Catarina
ClinicalTrials.gov Identifier: NCT02719704     History of Changes
Other Study ID Numbers: MEXA-SE
First Posted: March 25, 2016    Key Record Dates
Last Update Posted: March 25, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes