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Completed

NCT Number: NCT03153176

"Escola em Ação" (School in Action)

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.

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Key information

Conditions

Physical Activity Adolescent Behavior Behavior Behavior, Animal Dyssomnias Eating Behavior Feeding Behavior Mental Disorders Motor Activity Nervous System Diseases Personal Satisfaction Sedentary Behavior Sedentary Lifestyle Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

10 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sueyla Ferreira da Silva dos Santos

Presidente Prudente, São Paulo, 19060-900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Training

Behavioral

Training program 30 hours accumulated before, during and after intervention

Other names: Training program for Physical Education teacher

Individual level

Behavioral

7 to 10 minutes in Physical Education in class time, 3 sections for week during lunch break

Other names: Moderate to vigorous physical activity

Organizational level

Behavioral

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.

Other names: School health policy for healthy lifestyle

Primary outcomes

  1. Change from baseline in weekly time in moderate-to-vigorous physical activity at six months

    Time frame: Baseline, end of intervention (6 months), 1 year after baseline

    Measured with accelerometers for tenn days and supplemented with a questionnaire

  2. Change from baseline in weekly time in sedentary activity at six months

    Time frame: Baseline, end of intervention (6 months), 1 year after baseline

    Measured with accelerometers for tenn days and supplemented with a questionnaire

Secondary outcomes

  1. Change from baseline in Physical Education class time in moderate-to-vigorous physical activity at six months

    Time frame: Baseline, end of intervention (6 months), 1 year after baseline

    Measured with accelerometers in Physical Education class

  2. Change from baseline in level physical fitness at six months

    Time frame: Baseline, end of intervention (6 months), 1 year after baseline

    Measured with physical fitness test (abdominal resistance, palmar grip, horizontal jump, Wells bench, beep test)

  3. Change from baseline in body composition at six months

    Time frame: Baseline, end of intervention (6 months), 1 year after baseline

    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)

  4. Change from baseline in caloric intake at six months

    Time frame: Baseline, end of intervention (6 months), 1 year after baseline

    Measured with food register at 3 days and supplemented with a questionnaire

Other outcomes

  1. Change from baseline in the time and quality sleep at six months

    Time frame: Baseline, end of intervention (6 months), 1 year after baseline

    Measured with accelerometers for tenn days and supplemented with a questionnaire (Pittsburgh sleep quality index)

  2. Change from baseline in performance academic at six months

    Time frame: Baseline, end of intervention (6 months), 1 year after baseline

    Measured with school scores and state education performance exam

  3. Change from baseline in satisfaction with life at six months

    Time frame: Baseline, end of intervention (6 months), 1 year after baseline

    Measured with standardized questionnaire

Sponsors and collaborators

Lead sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Acronym: EA

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
May 15, 2017
Registry last updated
Jun 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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