- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03269513
OBESITY IN SCHOOLCHILDREN OF BASIC EDUCATION - Phase III 2017
OBESITY IN SCHOOLCHILDREN OF BASIC EDUCATION: a Study Interdisciplinary Intervention - Phase III
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Rio Grande do Sul
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Santa Cruz do Sul, Rio Grande do Sul, Brésil, 96815900
- Universidade de Santa Cruz do Sul
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- The official signing the informed consent and informed;
- The student with 12 years or older must sign the consent term;
- Age range: 10 to 17;
- Gender: male and female;
- No contraindications for blood collection;
- No distinction in relation to social class, ethnicity or color;
- To have a BMI greater than 85th percentile;
- Do not be participating in any other exercise program and dietary intervention;
- Participate in the clarification meetings on the project, when the head of the student is committed to the project, the following: a) assume responsibility for bringing to the UNISC (building 42) and refer to their home, the participant student of this study, both in the days of assessment (testing and completion of the data collection instruments), as in the days of intervention: 2nd, 4th and 6th fairs, from 14h to 16h, including 15 minutes in advance to the host, call and guidance students;
- Participate in intervention sessions during the period of 2 hours daily, the established days, following the guidelines given by the coordination of the project and the professionals of Physical Education, Nutrition, Psychology, Pharmacy, Physiotherapy, Medicine, Nursing and / or another area of health / education that can contribute to achieving the objectives of the intervention project;
- Participate in the assessments and reassessments as protocols established by the project.
Exclusion Criteria:
- Students who submit a frequency less than 70% stake in the intervention;
- Students who present contraindication to the practice of physical activity during the program implementation period;
- Students who choose not to continue with the treatment of intervention proposed by the program;
Be in possession of any kind of illness, abnormality or health problem such as:
- Hypertension untreated, Kidney diseases, Cardiac disorders, chronic renal failure, genetic diseases that have congenital malformations and mental retardation as Turner syndrome, Klinefelter syndrome and Down syndrome or cognitive impairment. And do not be carrying transmitted diseases vertically (from mother to child) with anatomical deformations caused by the interference of the pathogenic agent in the development process, as Congenital Toxoplasmosis (hydrocephalus, cerebral calcification, mental retardation, acute myocarditis, retinochoroiditis, strabismus, microphthalmia ), Rubella Syndrome, congenital (deafness, congenital cataracts, heart defects, microcephaly and mental retardation) congenital Syphilis (bone deformities, keratitis, deafness and mental retardation), cytomegalovirus infection congenital (microcephaly, intracranial calcifications and sensorineural deafness), because these subjects they need special care medical and/or service people trained for the specific purposes.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Aucune intervention: Groupe de contrôle
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Expérimental: Intervention group
Adolescent Obesity The exercise program, nutritional counseling and oral health will last for five to three months and will be held in the gym and rooms of the University of Santa Cruz do Sul (UNISC). The sessions will last two hours (one hour of physical exercise and the second time divided into nutritional counseling, postural, psychological and oral) with a frequency of three times a week. |
The sessions will last two hours (one hour of physical exercise and the second time divided into nutritional counseling, postural, psychological and oral) with a frequency of three times a week.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Change from body mass index (BMI) at 3 months
Délai: Baseline and 3 months.
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Weight and height will be evaluated early in the morning in a fasting state, with the student wearing light clothing and shoes.
The BMI will be classified as normal BMI, overweight or obesity.The BMI will be classified according to the percentage curves of the Centers for Disease Control and Prevention / National Center for Health Statistics (CDC/NCHS) (2010) according to gender and age, considering the low weight (<p5), normal weight (p5 and <p85), overweight (p 85 and <p 95) and obesity (p 95).
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Baseline and 3 months.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Change from the percentage of body fat at 3 months
Délai: Baseline and 3 months.
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To measure body fat percentage (BF%), a Lange (Beta Technology Incorporated) compass will be used to measure triceps and subscapular skinfolds.
The equation of Slaughter et al. (1998) will be applied, and data will be classified according to Lonman's data, as mentioned by Heyward and Stolarczyk (2000).
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Baseline and 3 months.
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Change from the waist circumference (WC) at 3 months
Délai: Baseline and 3 months.
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Waist circumference (WC) was measured with an inelastic tape, using the narrowest part of the trunk between the ribs and the iliac crest and the hip at the greater trochanter level as references.
The subjects were then classified according to Taylor et al. (2000), defining the normal circumference percentile as <80 and obesity percentile as >80 according to gender and age.
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Baseline and 3 months.
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Miria S Burgos, Dra, Universidade de Santa Cruz do Sul
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- UNISC
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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