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

Physical Fitness Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02719704
• Other study ID #: MEXA-SE
• Status: Completed
• Phase: N/A
• First received: February 29, 2016
• Last updated: March 21, 2016
• Start date: March 2015
• Est. completion date: July 2015

Study information

• Verified date: March 2016
• Source: Santa Catarina Federal University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 568
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 18 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Body Image
• Physical Fitness

Intervention

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.
• "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.

Locations

Country	Name	City	State
Brazil	Federal University of Santa Catarina	Florianópolis	Santa Catarina

Sponsors (1)

Lead Sponsor	Collaborator
Santa Catarina Federal University

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Change on skinfold thickness	Anthropometric measurements of skinfold thickness (millimeters) of biceps, triceps, subscapular, iliac crest and medial calf.	Baseline, 14 weeks	Yes
Primary	Change on flexibility	Modified Sit and Reach test (centimeters).	Baseline, 14 weeks	Yes
Primary	Change on muscular strength	Handgrip test measured by dynamometer (Kilograms).	Baseline, 14 weeks	Yes
Primary	Change on resistance levels	Modified abdominal test (number of repetitions).	Baseline, 14 weeks	Yes
Primary	Change on cardiorespiratory fitness	20-m shuttle run test (laps).	Baseline, 14 weeks	Yes
Primary	Change on body image	Self-perception (questionnaire).	Baseline, 14 weeks	Yes
Primary	Change on lipid	Enzymatic colorimetric test	Baseline, 14 weeks	Yes
Primary	Change on girth	Anthropometric measurements of girth (centimeters) of relaxed arm and waist.	Baseline, 14 weeks	Yes
Primary	Change on glucose profile	Enzymatic colorimetric test	Baseline, 14 weeks	Yes
Primary	Change on percent body fat	Measurement by bioelectrical impedance.	Baseline, 14 weeks	Yes
Primary	Change on fat free mass	Measurement by bioelectrical impedance.	Baseline, 14 weeks	Yes
Primary	Change on percent of water	Measurement by bioelectrical impedance.	Baseline, 14 weeks	Yes
Primary	Change on resistance	Measurement by bioelectrical impedance.	Baseline, 14 weeks	Yes
Primary	Change on reactance	Measurement by bioelectrical impedance.	Baseline, 14 weeks	Yes
Secondary	Change on physical activity at school	ActiGraph accelerometers.	Baseline, 14 weeks	Yes
Secondary	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.	Baseline, 14 weeks	Yes
Secondary	Change on sedentary behaviour (television time)	Time in front of television during the week and over the weekend reported in guided questionnaire.	Baseline, 14 weeks	Yes
Secondary	Change on sedentary behaviour (computer time)	Time in computer and / or video games during the week and over the weekend reported in guided questionnaire.	Baseline, 14 weeks	Yes
Secondary	Change on blood pressure levels	Measured by Automatic blood pressure monitor.	Baseline, 14 weeks	Yes
Secondary	Food consumption	Food consumption reported in guided questionnaire.	Baseline, 14 weeks	Yes
Secondary	Food Knowledge	Knowledge consumption reported in guided questionnaire.	Baseline, 14 weeks	Yes