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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: REBEC
Last refreshed on: 29 May 2023
Main ID:  RBR-6ddpb3
Date of registration: 29/01/2016
Prospective Registration: No
Primary sponsor: Universidade Federal de São Paulo
Public title: Prevention program of obesity and eating disorders developed with adolescents from public schools of São Paulo
Scientific title: 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: 02/02/2014
Target sample size:
Recruitment status: Recruitment completed
URL:  http://ensaiosclinicos.gov.br/rg/RBR-6ddpb3
Study type:  Intervention
Study design:  Prevention, parallel, open, two-arm, randomized controlled, prospective.  
Phase:  N/A
Countries of recruitment
Brazil
Contacts
Name: Karin Louise Lenz   Dunker
Address:  Rua Borges Lagoa 570 - 7o andar 04038-000 São Paulo Brazil
Telephone: +551155764491
Email: kdunker00@yahoo.com.br
Affiliation:  Universidade Federal de São Paulo
Name: Karin  Louise Lenz   Dunker
Address:  Rua Engenheiro Jorge Oliva, 237 - apto 112A 04362-060 São Paulo Brazil
Telephone: +5511981498654
Email: kdunker00@yahoo.com.br
Affiliation:  Universidade Federal de São Paulo
Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
Obesity and Eating Disorders
F03.375
C18.654.726.500
Intervention(s)
Behavioural
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
N02.421.726.758
Primary Outcome(s)
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%.
Secondary Outcome(s)
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.
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.
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.
Secondary ID(s)
Source(s) of Monetary Support
Fundação de Amparo a Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Escolas Estaduais Públicas de São Paulo
Secondary Sponsor(s)
Universidade Federal de São Paulo
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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