Clinical trial NCT03153176: "Escola em Ação" (School in Action)
Official title: "Escola em Ação": School Based Interventions of Incentive to the Practice Physical and Life Habits of Healthy Promotion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Eating Behavior
Sedentary Lifestyle
Adolescent Behavior
Keywords: physical activity
physical fitness
eating habits
sedentary behavior
sleep quality
satisfaction personal
school health
adolescent
Lead sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2017-05-15
Enrollment: 357
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: physical activity and lifestyle intervention
Primary purpose: OTHER

Brief summary: Background: The health promotion actions carried out in the school environment have positive effects on reducing risk factors for chronic diseases in adolescents. Interdisciplinary strategies involving school and family to increase the level of physical activity among adolescents, inside and outside the school, are essential to encourage healthier lifestyles.

Aim: To determine whether a 24-weeks interdisciplinary intervention program promotes improvement in the level of physical activity, physical fitness, sleep quality, life satisfaction, eating habits and reduce the sedentary behavior of schoolchildren aged 10 to 13 years of public schools in the city of Presidente Prudente, São Paulo, Brazil.

The intervention: Includes training of teacher Physical Education in the principles of self-determination theory and ecological theory at practical applications for motivating adolescents in physical activities and sports. The students will be given information on the benefits of a physically active lifestyle and will be encouraged to participated the new opportunities for physical activity in their school and community. The program will offer physical activity strategies over the 24-weeks during class Physical Education, afternoon recess and active lesson breaks in theoretical classes. Nutritional guidelines and gardening experience will be developed to encourage healthy eating habits among schoolchildren and to reduce salt, oil and sugar in the preparation of school lunch.

Methods/design: The project, which being conducted as cluster randomized trial, is to evaluated whit in a mixed methods, including qualitative and quantitative approach will be used for the construction of the actions integrated to the school physical education curriculum and evaluation of the program by the participants and supporters. The RE-AIM evaluation metric (Reach, Effectiveness, Adoption, Implementation, and Maintenance) is used to guide the validation this program.

Detailed description: The intervention will be unfold over the 24-weeks with students of six to seven school terms of implementation physical activity and nutrition intervention strategies. The total of five schools full-time were contacted for participation in the survey, one was excluded because they had no interest in participating. Allocation of pairs of schools in the experimental and control groups was done by randomization (draw for the experimental and control groups), and later the schools were informed about their condition in the study (experimental group or control group). The dimensions assessed in the research were defined from the problems and needs pointed out by the school in the initial stage of training and diagnosis of the local reality. The intervention strategies consisted of the following across: promote teacher Physical Education training; develop school actions integrated in the school curriculum; increase pratice of physical activity (in class time and recess); Improve eating habits (nutritional guidence, gardening experience, school lunch); promote healthy lifestyle program during school breaks; provided with physical activity equipment; parent engagement in health education practice.

Eligibility criteria: Inclusion Criteria:

* Students enrolled in 2017, in the 6th and 7th year of Elementary School in the full-time schools participating in the study

Exclusion Criteria:

* Students with physical or motor impairment that prevents the performance of physical fitness assessments or with mental or cognitive impairment that prevents them from responding with clarity to the questionnaires and instruments of data collection

Primary outcomes:
measure: Change from baseline in weekly time in moderate-to-vigorous physical activity at six months
timeFrame: Baseline, end of intervention (6 months), 1 year after baseline
measure: Change from baseline in weekly time in sedentary activity at six months
timeFrame: Baseline, end of intervention (6 months), 1 year after baseline
Secondary outcomes:
measure: Change from baseline in Physical Education class time in moderate-to-vigorous physical activity at six months
timeFrame: Baseline, end of intervention (6 months), 1 year after baseline
measure: Change from baseline in level physical fitness at six months
timeFrame: Baseline, end of intervention (6 months), 1 year after baseline
measure: Change from baseline in body composition at six months
timeFrame: Baseline, end of intervention (6 months), 1 year after baseline
measure: Change from baseline in caloric intake at six months
timeFrame: Baseline, end of intervention (6 months), 1 year after baseline
Other outcomes:
measure: Change from baseline in the time and quality sleep at six months
timeFrame: Baseline, end of intervention (6 months), 1 year after baseline
measure: Change from baseline in performance academic at six months
timeFrame: Baseline, end of intervention (6 months), 1 year after baseline
measure: Change from baseline in satisfaction with life at six months
timeFrame: Baseline, end of intervention (6 months), 1 year after baseline
Locations:
city: Presidente Prudente
country: Brazil
facility: Sueyla Ferreira da Silva dos Santos
state: São Paulo
Study officials:
affiliation: CELAPAM
name: Ismael Freitas Junior, Phd
role: STUDY_DIRECTOR
References:
citation: Ferreira da Silva Dos Santos S, Bordin D, Dornelas de Souza EF, Freitas Junior IF. Study protocol and baseline characteristics of "SCHOOL IN ACTION" program on support to physical activity and healthy lifestyles in adolescents. Contemp Clin Trials Commun. 2019 Dec 14;17:100505. doi: 10.1016/j.conctc.2019.100505. eCollection 2020 Mar.