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-6ddpb3 |
Date of registration:
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29/01/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Prevention program of obesity and eating disorders developed with adolescents from public schools of São Paulo
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Scientific title:
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Integrated prevention program of obesity and eating disorders: a pilot study, randomized trial comparing the effects of the "New Moves" applied in public schools of São Paulo. |
Date of first enrolment:
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02/02/2014 |
Target sample size:
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Recruitment status: |
Recruitment completed |
URL:
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http://ensaiosclinicos.gov.br/rg/RBR-6ddpb3 |
Study type:
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Intervention |
Study design:
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Prevention, parallel, open, two-arm, randomized controlled, prospective.
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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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Karin Louise Lenz
Dunker |
Address:
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Rua Borges Lagoa 570 - 7o andar
04038-000
São Paulo
Brazil |
Telephone:
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+551155764491 |
Email:
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kdunker00@yahoo.com.br |
Affiliation:
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Universidade Federal de São Paulo |
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Name:
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Karin Louise Lenz
Dunker |
Address:
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Rua Engenheiro Jorge Oliva, 237 - apto 112A
04362-060
São Paulo
Brazil |
Telephone:
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+5511981498654 |
Email:
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kdunker00@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: In both groups is considered as an inclusion criterion:
being female;
having between 12 and 14 full years;
agree and sign the consent term of the study (students and their parents)
Exclusion criteria: Have 15 years or more;
practice more than one hour of exercise a day; vomit or use laxatives weekly
Age minimum:
12Y
Age maximum:
14Y
Gender:
F
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Health Condition(s) or Problem(s) studied
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Obesity and Eating Disorders
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F03.375
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C18.654.726.500
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Intervention(s)
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Behavioural
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Intervention group: 30 girls from five public schools (total = 150) were invited to participate in the program "New Moves" lasting two quarters after school period (program phase and maintenance phase). In the first quarter meetings occurs in nine weeks (twice a week). Meetings last two hours per day. Once a week (one hour with topics related to psychology and an hour of physical activity), once a week (one hour with issues related to nutrition and an hour of practice of physical activity). Also they were offered participation in two individual interviews through a motivational interview script to motivate behavior change worked in the program. All topics discussed are based on materials (manual of girls and dynamic classes) of the original program "New Moves" which were translated and adapted for the study. In the second quarter meetings take place in nine weeks (once a week lasting an hour). In this meeting we discuss the issues interchangeably (psychology, nutrition and physical activity). Data were collected at three moments. Before the phase of the program, after and after the maintenance phase they were evaluated by the following questionnaires administered by trained interviewers: Specific questionnaire developed by the program authors to evaluate issues discussed in the program "New Moves Survey"; economic assessment; Body Shape Questionnaire, Rosenberg self-esteem scale and 24h food recall. Participants also used accelerometers for 7 days to assess level of physical activity before and after the program phase. Control group: 30 girls from five schools (total = 150) were invited to participate in the fulfillment of the same questionnaires at the same moments. At the end of the intervention participated in a meeting lasting two hours where they di
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N02.421.726.758
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Primary Outcome(s)
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Reduction of Body Image Questionnaire score following phase of the program, and maintain or reduce the score after the maintenance phase. For the study will be considered a difference of situation between times, and/or between groups, when there is an improvement of at least 7% from one moment to the other (or from one group to another) in relation to body satisfaction initial. The statistical technique used to calculate the difference between the means of body satisfaction was the analysis of variance with repeated measures. This is repeated measurements, since evaluations in different times refer to the same individual. Based on the above definitions, for the calculation of sample size was considering a significance level of 5% and a power of 80%.
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Secondary Outcome(s)
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Increase level of physical activity from the measure of the number of steps by using a week of accelerometer. For finding the expected outcome, a variation of at least 5% relative to the number of steps and pre post stage of the program will be considered.
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Increase score of the self-esteem Rosenberg scale. For finding the expected outcome, a variation of at least 5% relative to Rosenberg scale score will be considered.
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Reduction of unheathy behaviors of weight control in the last month recorded in the questionnaire "New Moves Survey" (fasting, eating little, take medicine to lose weight,
diuretics, laxatives, induce vomiting, smoking cigarettes, using food substitutes, skipping meals, make specific diet to control weight) .For finding the expected outcome will be considered a variation of at least 5% compared to frequency of use of these pre methods and post-stage of the program.
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Source(s) of Monetary Support
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Fundação de Amparo a Pesquisa do Estado de São Paulo
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Conselho Nacional de Desenvolvimento Científico e Tecnológico
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Escolas Estaduais Públicas 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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