Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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REBEC |
Last refreshed on:
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29 May 2023 |
Main ID: |
RBR-38p23s |
Date of registration:
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18/07/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Psychological treatment for obese adolescents and their effects on social interaction and body mass index
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Scientific title:
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Multifocal intervention in obese adolescents: social competence,
behavior problems, academic performance and weight reduction |
Date of first enrolment:
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18/02/2010 |
Target sample size:
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Recruitment status: |
Data analysis completed |
URL:
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http://ensaiosclinicos.gov.br/rg/RBR-38p23s |
Study type:
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Intervention |
Study design:
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Therapeutic study, parallel, 3-arm, open, randomized controlled
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Phase:
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N/A
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Graziela
Sapienza |
Address:
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Rua Capitão Mor Goes e Moraes, 94
02525060
São Paulo
Brazil |
Telephone:
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+55(11)30245082 |
Email:
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graziela_sapienza@yahoo.com.br |
Affiliation:
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Universidade Federal de São Paulo |
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Name:
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Graziela
Sapienza |
Address:
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Rua Capitão Mor Goes e Moraes, 94
02525060
São Paulo
Brazil |
Telephone:
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+55(11)30245082 |
Email:
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graziela_sapienza@yahoo.com.br |
Affiliation:
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Universidade Federal de São Paulo |
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Key inclusion & exclusion criteria
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Inclusion criteria: Both mass index above than the 95th percentile for age featuring obese according to the curves of the Center for Disease Control and Prevention (CDC, 2000); between 10 and 19 years old; willingness to participate in all program activities.
Exclusion criteria: Psychological disorders; use of medications that could interfere in the variables; physical difficulties that impeded the development of all activities.
Age minimum:
10Y
Age maximum:
19Y
Gender:
-
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Health Condition(s) or Problem(s) studied
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C18.654.726.500
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F01.829.401
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Obesity; interpersonal relationships
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Intervention(s)
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F04.754.137
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G1 – Complete experimental group (n=13). It involved 20 meetings with the adolescents divided into 16 for the psychological intervention (2 times per week), and 04 monthly for the nutritional orientations; 09 meetings with parents, of which 06 bi-weekly, 02 nutritional meetings (01 in the beginning and the other after 30 days) and also um meeting with a physical educator in the first week of the intervention, I addition to 36 sessions of physical exercises for all adolescents, conducted 03 times per week. G2 – Simple experimental group (n=15) : 04 monthly meetings with adolescents for nutritional orientation, 09 meetings with the parents (06 bi-weekly with a psychologist, 02 with a nutritionist and 01 with a physical educator) and 36 sessions of physical exercises for adolescents. G3 – Control group (n=11): not having psychological intervention, simply meetings with a nutritionist and a physical educator for the adolescents and parents and physical exercises sessions for the adolescents. The psychological intervention was a behavioral approach and contained life experience activities toward the learning of skills such as self-control, assertiveness, solving problems (including nicknaming and bullying) and reading the context that contribute to the reduction of behavioral problems and to the gain of self-worthiness skills, such as self-esteem, self-efficacy, therefore enhancing the social competence. The parents' counseling orientation had as an objective to teach and provide antecedent and consolidated conditions of behaviors socially accepted to their progenies, concurrently discussed positive means to establish rules and boundaries in regard to feeding and other day-to-day matters. The nutritional orientation for adolescents and parents was conducted by a nutr
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Behavioural
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F01.829.401
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Primary Outcome(s)
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Increased social competence score checked by the Child Behavior Checklist. Reducing behavior problems checked by the Child Behavior Checklist. Increase in academic performance verified by higher grades in the school. Reduction in body mass index checked in anthropometric assessment, whereas the curves of the CDC (2000). These outcomes are expected soon after treatment and after 9 months of intervention. In all outcomes, it is considered a variation of at least 5% of the score on before/after comparison.
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Obese adolescents who participated of the full intervention group, increased their social competence score, reduced behavior problems, reduced body mass index and maintained this reduction for one year.
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Secondary Outcome(s)
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Não são esperados desfechos secundários.
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Source(s) of Monetary Support
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Universidade Federal de São Paulo
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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