Clinical Trials Logo

Clinical Trial Summary

Background:

Interventions on lifestyle among adolescents are important, but the main mechanisms that explain the changes (mediating variables) on lifestyle have been little explored. Investigators present the rationale and methods of a cluster-randomized controlled trial aimed to promote promotion active and healthy lifestyle (especially physical activity [PA] practice and reducing screen time use) among Brazilian students - the "Fortaleça sua Saúde" ("Strengthen Your Health" in Portuguese) program.

Methods/Design:

This is a school-based cluster-randomized controlled trial that included students from six elementary full-time public schools (7-9 grades) in Fortaleza, northeastern Brazil. The intervention duration was one academic semester (approximately four months) in 2014. The intervention strategies focused on teachers' training and activities on health in curriculum (including a specific training to Physical Education teachers), active opportunities in the school environment (availability of spaces and materials for PA) and health education (production and exhibition of health material at school, and distributing pamphlets to patients). Data collection will be performed before and immediately after 4 months of intervention. The primary variables include the practice of PA (weekly PA volume) and the screen time use (TV/computer/video games). Intrapersonal, interpersonal and environmental variables associated to PA and screen time use will be evaluated by standardized questionnaire. Other components of the lifestyle (e.g., eating habits), psychological (e.g., self-rated health, body satisfaction), biological (general and abdominal obesity) and academic performance will be also evaluated in the patients. Depressive symptoms, eating disorders, sleep quality, objectively-measured physical activity will be evaluated in obese patients.

Discussion:

Is effective, this program will contribute to the development of public policies for active and health lifestyle promotion among young population, especially from low- and middle-income countries. The main variables (intrapersonal, interpersonal and/or environmental stimulus) that help the young people to adopt an active lifestyle also may be indicated. Finally, investigators expect that the proposed strategies may be adaptable to the public school reality and they may be extended to the entire school system.


Clinical Trial Description

Setting and Population:

Fortaleza is the capital of Ceara state, northeastern Brazil, and has a population of 2,452,185 inhabitants (the fifth largest city in Brazil considering the population). This municipality has an area of 314 km² and a Human Development Index (HDI) of 0.754. The city of Fortaleza is geographically divided into six administrative regions.

According to the Municipal Education Department, forty schools attended 6-9 grades and included the Programa Saúde na Escola, and six out of these schools had a full-time education model. These six schools attended approximately 2,500 students, of which 1,272 were enrolled in classes from 7th to 9th grades.

These six schools had similar characteristics (e.g., size, target audience, curriculum, etc.) and were located in different administrative regions (geographically disperses). Therefore, there was no need to conduct peer schools during random selection to prevent study contamination. Three schools were randomly selected to intervention group and other schools were control group. The neighborhood-HDI from where the six schools were located was similar between groups (neighborhood-HDI of 0.215, 0.341 and 0.443 for intervention schools, and 0.170, 0.377 and 0.491 for control schools).

Theoretical basis of the "Fortaleça sua Saúde" program:

The "Fortaleça sua Saúde" program was structured considering different theoretical aspects. The Socioecological Theory emphasizes that intrapersonal (e.g., knowledge, self-efficacy), interpersonal (social support, peer and family model) and environmental (perception and environmental characteristics) aspects interfere independently and interactively in the individual's behavior. The actions of the program "Fortaleça sua Saúde" program were directed to achieve these different levels. The concepts of the Health Promoting in Schools was also used. Three characteristics were used in order to choice the program components: Health education topics in the formal school curriculum, health values, attitudes and opportunities promoted within the school, and schools seek to engage with families, outside agencies and the wider community.

Description of the Intervention:

The "Fortaleça sua Saúde" intervention during the second scholar semester (approximately four months).

Training and activities in general curriculum:

All teachers from three intervention schools were invited to participate of training and to execute class activities focused on the discussion of active and healthy lifestyle. Full training was structured in three stages (two face-stages and one distance-stage) with certification recognized by the University.

A four-hour training were performed at the beginning of school semester. Discussions on primary health concepts and the importance of these issues were made, including the relationship between health, school and academic performance. Proposals for cross-cutting issues including the National Curriculum Standards were also discussed. Finally, strategies directed to combine teaching tools (e.g., homework, tests presentations) and health issues (e.g., physical activity [PA], quality of life, health eating) were discussed.

Teachers received a supplemental manual in order to help the classroom activities. This manual was prepared by program staff based on other productions on health in school, but they were adapted to the reality of Fortaleza's schools and students. Brazilian documents on education were consulted including the Learning Expectations of the Municipal Education Department and the National Curriculum Standards on health topics. Ministerial reports on health and education were also consulted. The manual included proposals for activities according to knowledge areas (i.e., languages, social sciences, natural sciences and mathematics). For example, in mathematics, an included proposal was about teaching "quantities and measures" using body measures, PA energy expenditure energy consumption in meals. Each proposal included description, required material, alternative, observations and supporting texts. Teachers who could not attend the training also had access to the manual and could participate in other stages of formation.

Teachers were encouraged to make the activities during the semester that were discussed during training, or create and implement similar strategies in the classroom. In general, the activities performed in the classroom included text production, videos/posters/booklets production and exposition with health issues content. The issues content in the manual could be suitable for the interests and expertise of teachers and patients (students) as well as the structural conditions of each school. A social page was created in order to monitor, assist and promote activities among teachers from the intervention schools. Finally, a meeting with the teachers of each school was made at the end of the semester to discuss the implementation of these activities.

Training and activities in Physical Education classes:

Investigators conducted a four-hour training specified to the Physical Education teachers at the beginning of school semester. Theachers were instructed to structure the predominantly active Physical Education classes, even in classes with theoretical content purposes. For example, a class focused on PA types and the relation between PA and healthy diet would be structured with a dynamic way. Investigators considered this because the active time in Physical Education classes can be a beneficial factor to total PA and adolescent health.

A supplemental manual with lesson plans and handouts was also developed and distributed to teachers. This manual was built for the program staffs and was organized by grades (7-9 grades). Materials from the Educação Física+ Project, Physical Education-specific National Curriculum Standards and health issues were used to create the manual. The manual included four units with different chapters: (i) PA and health (e.g., PA and leisure, cooperative games, PA with parents); (ii) health factors (e.g., excessive sedentary time, diabetes, hypertension, quality of life); (iii) sports (e.g., athletics, volleyball, functional training, fights); and (iv) popular games (e.g., games and dance, adventure sports). The production of posters and texts by the patient (students) with health issues content was performed as classwork or homework.

All Physical Education classes (20 classrooms with two Physical Education classes per week) during the semester were supported by a undergraduate Physical Education student. This staff collaborated in the planning of activities, material procurement organization and implementation of lessons. Additionally, one Physical Education-related event (e.g., dance festival or games competitions) were organized in order to combine Physical Education classes and school cultural events (e.g., student's week) and to encourage the active participation during school events.

Active opportunities in school environment:

These intervention strategies aimed to promote PA opportunities within the school and stimulate it in out-school time, as well as disseminate information on the importance of an active and healthy lifestyle. Supervised and unsupervised activity were considered. Some of these strategies were focus on the engagement of girls - a high-risk subgroup for inactive lifestyle.

All these strategies were implemented at the beginning of the program. Staffs, implemented these strategies in the first two weeks of semester in order to guide the execution, material access and understanding of the rules of the games. During the semester, some Physical Education classes and "Gym in School" sessions were performed using these games in order to stimulate its realization during free-time at school. Explanatory banners were exposed in schools with content on the games rules and material access. Motivational (e.g., "Let's play with the friends!") and health (e.g., "Practice PA with friends is very good for health!") messages were also included in the banners.

Health education in school community:

Some of the previous strategies had an additional focus on promoting awareness about the benefits of an active and healthy lifestyle. Principally, the materials produced in the classroom in general and Physical Education classes and the banners exposed in schools.

Additionally, pamphlets with messages on active and healthy lifestyle were distributed at intervention schools. The program team made these pamphlets and they based on other materials programs. The content was adapted to the program objectives and local reality. Teachers and professionals specialized in health education to young people made the content selection. After this, marketing experts of the Municipal Education Department executed the graphical structure of the pamphlets.

The pamphlets were delivered in the first month to a member of the school administration (coordinator or director). Guidelines were passed on the objectives of the pamphlets and as they could be distributed. In general, the pamphlets focused on the patients (students were delivered during the early times of the school day or during classes. The pamphlets focused on parents were delivered during parents/teachers meetings or in parent visits to school. Teachers were encouraged to use the pamphlets during lessons with health messages. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02439827
Study type Interventional
Source Universidade Federal de Santa Catarina
Contact
Status Completed
Phase N/A
Start date July 2014
Completion date June 2015

See also
  Status Clinical Trial Phase
Completed NCT05071989 - The Influence of Sleep Education With Social Media Reminders on the Sleep Quality in Adolescents N/A
Recruiting NCT05064293 - Assisted Identification and Navigation of Early Mental Health Symptoms in Children N/A
Enrolling by invitation NCT05017779 - A Hybrid Effectiveness-implementation Trial of a High School-based Executive Function Treatment for Autistic Youth N/A
Completed NCT03685643 - Study Proposal for Web Based Intervention to Promote the Safe Usage of Dating Applications in Young Adults N/A
Completed NCT03270943 - The S.M.A.R.T. Project: Stress Management and Resilience Training for Teens N/A
Recruiting NCT05525962 - Vulnerability/Resilience Factors Influencing the Developmental Trajectories and Adaptive Methods of Children and Adolescents in Child Welfare System.
Completed NCT03411577 - Development and Testing of a Jamaican Mother-daughter HIV Risk-reduction Program N/A
Recruiting NCT05334381 - Navigating Mental Health Treatment for Black Youth N/A
Active, not recruiting NCT05926141 - Advanced Cooking Education Pilot Study N/A
Recruiting NCT04317547 - Translation Study of a Safe Teen Driving Intervention N/A
Recruiting NCT06001892 - Tennessee Youth Prepared for Success N/A
Enrolling by invitation NCT06127277 - Next4You: A Fully Mobile Relationships Based Program for Youth in Foster Care N/A
Not yet recruiting NCT06310434 - Analysis of COMPASsion and Humanisation of Adolescents Facing the End-of-life Processes.
Not yet recruiting NCT05316948 - Mental Health and Sexuality in Adolescents and Young Adults
Terminated NCT02578147 - JUEGA: A Fun Study for Hispanic/Latino Adolescent Girls N/A
Completed NCT02683811 - Effectiveness of the Updated Version of the School-based Program Diario Della Salute (DDS-2) N/A
Active, not recruiting NCT02329015 - Curriculum Evaluation of a Novel Health and Wellness Program Within New York City Schools Phase 1
Completed NCT03482687 - It's Your Game: An Innovative Approach to Preventing Teen Dating Violence N/A
Completed NCT01433679 - The Effect of a Web-Based Behavioral Intervention on Physical Activity Levels in Adolescents N/A
Completed NCT00056953 - Peer Mentors for Adolescents in HIV Affected Families Phase 2