"Escola em Ação" (School in Action)

Physical Activity Clinical Trial

— EA  

Official title:

"Escola em Ação": School Based Interventions of Incentive to the Practice Physical and Life Habits of Healthy Promotion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03153176
• Other study ID #: UNESP Presidente Prudente
• Status: Completed
• Phase: N/A
• Start date: May 8, 2017
• Est. completion date: December 7, 2018

Study information

• Verified date: June 2019
• Source: Universidade Estadual Paulista Júlio de Mesquita Filho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 357
• Est. completion date: December 7, 2018
• Est. primary completion date: June 9, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Behavior
• Eating Behavior
• Physical Activity
• Sedentary Lifestyle

Intervention

Behavioral:
• Training
Training program 30 hours accumulated before, during and after intervention
• Individual level
7 to 10 minutes in Physical Education in class time, 3 sections for week during lunch break
• Organizational level
Inclusion of actions in the school curriculum: counseling sections with health for parents and adolescent, active lesson breaks during theoretical class, gardening experience in school, nutrition guidance for school lunch professionals.

Locations

Country	Name	City	State
Brazil	Sueyla Ferreira da Silva dos Santos	Presidente Prudente	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Estadual Paulista Júlio de Mesquita Filho	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in the time and quality sleep at six months	Measured with accelerometers for tenn days and supplemented with a questionnaire (Pittsburgh sleep quality index)	Baseline, end of intervention (6 months), 1 year after baseline
Other	Change from baseline in performance academic at six months	Measured with school scores and state education performance exam	Baseline, end of intervention (6 months), 1 year after baseline
Other	Change from baseline in satisfaction with life at six months	Measured with standardized questionnaire	Baseline, end of intervention (6 months), 1 year after baseline
Primary	Change from baseline in weekly time in moderate-to-vigorous physical activity at six months	Measured with accelerometers for tenn days and supplemented with a questionnaire	Baseline, end of intervention (6 months), 1 year after baseline
Primary	Change from baseline in weekly time in sedentary activity at six months	Measured with accelerometers for tenn days and supplemented with a questionnaire	Baseline, end of intervention (6 months), 1 year after baseline
Secondary	Change from baseline in Physical Education class time in moderate-to-vigorous physical activity at six months	Measured with accelerometers in Physical Education class	Baseline, end of intervention (6 months), 1 year after baseline
Secondary	Change from baseline in level physical fitness at six months	Measured with physical fitness test (abdominal resistance, palmar grip, horizontal jump, Wells bench, beep test)	Baseline, end of intervention (6 months), 1 year after baseline
Secondary	Change from baseline in body composition at six months	Measured with Dual-energy X-ray absorptiometry (DXA) and anthropometric measurements (body height, body weight, waist circumference, hip circumference, arm circumference, triceps skin fold and puberty status (self- assessed)	Baseline, end of intervention (6 months), 1 year after baseline
Secondary	Change from baseline in caloric intake at six months	Measured with food register at 3 days and supplemented with a questionnaire	Baseline, end of intervention (6 months), 1 year after baseline