- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03153176
"Escola em Ação" (School in Action) (EA)
"Escola em Ação": School Based Interventions of Incentive to the Practice Physical and Life Habits of Healthy Promotion
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.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
São Paulo
-
Presidente Prudente, São Paulo, Brasilien, 19060-900
- Sueyla Ferreira da Silva dos Santos
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: intervention
Training program for Physical Education teacher.
Individual level: moderate to vigorous physical activity.
Organizational level: school health policy for healthy lifestyle
|
Training program 30 hours accumulated before, during and after intervention
Andra namn:
7 to 10 minutes in Physical Education in class time, 3 sections for week during lunch break
Andra namn:
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.
Andra namn:
|
Inget ingripande: no intervention
Physical Education and school curriculum as usual
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change from baseline in weekly time in moderate-to-vigorous physical activity at six months
Tidsram: Baseline, end of intervention (6 months), 1 year after baseline
|
Measured with accelerometers for tenn days and supplemented with a questionnaire
|
Baseline, end of intervention (6 months), 1 year after baseline
|
Change from baseline in weekly time in sedentary activity at six months
Tidsram: Baseline, end of intervention (6 months), 1 year after baseline
|
Measured with accelerometers for tenn days and supplemented with a questionnaire
|
Baseline, end of intervention (6 months), 1 year after baseline
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change from baseline in Physical Education class time in moderate-to-vigorous physical activity at six months
Tidsram: Baseline, end of intervention (6 months), 1 year after baseline
|
Measured with accelerometers in Physical Education class
|
Baseline, end of intervention (6 months), 1 year after baseline
|
Change from baseline in level physical fitness at six months
Tidsram: 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)
|
Baseline, end of intervention (6 months), 1 year after baseline
|
Change from baseline in body composition at six months
Tidsram: 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)
|
Baseline, end of intervention (6 months), 1 year after baseline
|
Change from baseline in caloric intake at six months
Tidsram: Baseline, end of intervention (6 months), 1 year after baseline
|
Measured with food register at 3 days and supplemented with a questionnaire
|
Baseline, end of intervention (6 months), 1 year after baseline
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change from baseline in the time and quality sleep at six months
Tidsram: 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)
|
Baseline, end of intervention (6 months), 1 year after baseline
|
Change from baseline in performance academic at six months
Tidsram: Baseline, end of intervention (6 months), 1 year after baseline
|
Measured with school scores and state education performance exam
|
Baseline, end of intervention (6 months), 1 year after baseline
|
Change from baseline in satisfaction with life at six months
Tidsram: Baseline, end of intervention (6 months), 1 year after baseline
|
Measured with standardized questionnaire
|
Baseline, end of intervention (6 months), 1 year after baseline
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Studierektor: Ismael Freitas Junior, Phd, CELAPAM
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- UNESP Presidente Prudente
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
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