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Sruthi Bhat
PAAPAS community trial protocol: A randomized study of
obesity prevention for adolescents combining school with
household intervention.
Summary of study
In Brazil, children and adolescents had the highest increase in the prevalence of obesity in the last decade, particularly
in urban low-income areas, which concentrates high percentage of the Brazilian population.
The aim of this study is to present a protocol to evaluate the efficacy of combining school and household level
interventions to reduce excessive weight gain among students.
The PAAPPAS study, which stands for “parents, health care agents, students, community trial agents and teachers for
healthy eating” is a school-based randomized research project in its fourth version. Intervention will occur during the
school year 2016 .
Brazil is internationally recognized for its development of primary health care at the local level. The Family Health
Strategy (FHS) Program in Brazil is a model of assistance centered on health teams, which had improved health
outcomes in Brazil .
As majority of adolescents in Brazil are students from public schools located in areas covered by FHS, it is reasonable
to combine primary and secondary prevention in school-based interventions in order to increase the chances of
effectiveness in this context.
Study population
The trial is a randomized community trial labeled PAAPPAS. In this study, two of four districts in Duque
de Caxias were included, and from 45 municipal schools.
 18 schools with fifth and sixth grades were selected and all they are eligible for this study.
 The exclusion criteria are students with physical disabilities and pregnant adolescents
 Sample size of 2500 students will be evaluated at school for their weight status .
 Schools were randomized half in control group and half in intervention group.(9 intervention and 9
control).
 Participants in control arm will receive only the routine activities for healthy behavior of the school.
Demographic, socioeconomic, anthropometric, eating behavior and food consumption data will be
collected at school using a standardized questionnaire programmed in personal digital assistant.
Interventions
Primary intervention:
 Based on literature review of eating behaviors, environmental factors associated with obesity and pilot
studies.
 The trained teacher will provide the overall basis for healthy life style, including food intake, physical
activity and sedentary habits.
Secondary intervention
 Those from the intervention group who are overweight(based on standard deviation of BMI =3) will be
followed monthly at home by community health agents.
 It is coordinated by the Health Secretary of the Municipality of Duque de Caxias and will be carried out
from June to December 2016 by the CHA.
 They will visit family every month and encourage life style changes at family level .
Data collection method at school
 Baseline questionnaire pre intervention [March-April]
 Post-intervention questionnaire [November-December] using personal digital assistant (PDA).
Anthropometric and body composition
 Weight, height and waist circumference at the lower value were measured using standardized procedures .
 body composition estimated by bioelectrical impedance, using the leg-to-leg Tania scale .
 Height was measured using a portable stadiometer.
 Overweight and obesity classification of the World Health Organization was used .
Food consumption
 It will be assessed by 24-h recall and a short (23 items) food frequency questionnaire (FFQ), which is a reduced
version of an FFQ validated for adolescents of Rio de Janeiro .
 The 24-h recall will use the BrasilNutri software, entering data during interviews in schools.
Measurement of physical activity
 It will include the evaluation of exercise, leisure activities, commuting to school, and sedentary activities
(video games, television and computer time) measured by questionnaire .
Outcomes.
 At the primary intervention level we are testing a reduction of 0.4 units of mean BMI .
 Secondary prevention program a reduction of 1.1 units of BMI is expected.
Secondary outcomes include body fat and waist circumference.
 Many behavior changes evaluated will allow measure the adherence to the intervention.
 The results of this study will be submitted for publication in next year and the methods
presented may contribute to develop effective interventions to reduce the growing prevalence of
obesity.
Advantage of study
 This is the first study that integrates school intervention with primary health care to prevent excessive
weight gain among adolescents. Previous studies and most of the literature have shown inconsistent
results of studies based on only in the school, thus this is a promising study.
 There are no established guidelines for childhood obesity. Thus, this project will inform possible
strategies to be disseminated in the health care system in Brazil .The CHA act in the territory in which
she/he is affiliated and serve as a mediator between families and health professionals.
 If positive results of the CHA intervention are observed, all CHA from Duque de Caxias, Rio de Janeiro
will be trained and materials developed used in the primary health care.
 Thus the current study presents the rationale and protocol development, pre-tests, and implementation
of the trial PAAPPAS, which combine primary prevention activities at school level with secondary
prevention at household level.
 This study will provide evidence whether integration of school with primary health care can prevent
excessive weight gain among adolescent.
Limitations.
 This study take place in one of the poorest areas in the state of Rio de Janeiro, intervention
group will be having certain demographic characteristics which it will be different from other
area and we cannot generalize the result to target population.
 To avoid this problem the intervention studies should increase the diversity of human
subjects.
 If the intervention group is not following the prescribed methods the outcome maybe
reduced.
 Children may move into other community after the intervention has began may lead to loss of
effect
 Is obesity in children a public health issue?
Public health importance
 Overweight children and adolescents are more likely to become overweight or obese adults; this concern is
greatest among adolescents.
 Type 2 diabetes, high blood lipids, and hypertension as well as early maturation and orthopedic problems
also occur with increased frequency in overweight youth overweight and obesity are associated with an
increased risk of disease and death, as previously discussed.
 Randomized controlled trials have shown that weight loss (as modest as 5 to 15 percent of excess total
body weight) reduces the risk factors for at least some diseases, particularly cardiovascular disease, in the
short term.
Reference
 Michele, R.S., Diana, B. C., Viviane, T. H., Camilla ,C. P., Estima, Bárbara, S. N., Souza, Rosangela, A. P.,
Edna M. Y., Vitor B.,. Paravidino and Rosely S. 17 August 2016. PAAPPAS community trial protocol: A randomized
study of obesity prevention for adolescents combining school with household intervention.
Http://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-016-3473-3

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Community trial design

  • 2. PAAPAS community trial protocol: A randomized study of obesity prevention for adolescents combining school with household intervention.
  • 3. Summary of study In Brazil, children and adolescents had the highest increase in the prevalence of obesity in the last decade, particularly in urban low-income areas, which concentrates high percentage of the Brazilian population. The aim of this study is to present a protocol to evaluate the efficacy of combining school and household level interventions to reduce excessive weight gain among students. The PAAPPAS study, which stands for “parents, health care agents, students, community trial agents and teachers for healthy eating” is a school-based randomized research project in its fourth version. Intervention will occur during the school year 2016 . Brazil is internationally recognized for its development of primary health care at the local level. The Family Health Strategy (FHS) Program in Brazil is a model of assistance centered on health teams, which had improved health outcomes in Brazil . As majority of adolescents in Brazil are students from public schools located in areas covered by FHS, it is reasonable to combine primary and secondary prevention in school-based interventions in order to increase the chances of effectiveness in this context.
  • 4. Study population The trial is a randomized community trial labeled PAAPPAS. In this study, two of four districts in Duque de Caxias were included, and from 45 municipal schools.  18 schools with fifth and sixth grades were selected and all they are eligible for this study.  The exclusion criteria are students with physical disabilities and pregnant adolescents  Sample size of 2500 students will be evaluated at school for their weight status .  Schools were randomized half in control group and half in intervention group.(9 intervention and 9 control).  Participants in control arm will receive only the routine activities for healthy behavior of the school. Demographic, socioeconomic, anthropometric, eating behavior and food consumption data will be collected at school using a standardized questionnaire programmed in personal digital assistant.
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  • 6. Interventions Primary intervention:  Based on literature review of eating behaviors, environmental factors associated with obesity and pilot studies.  The trained teacher will provide the overall basis for healthy life style, including food intake, physical activity and sedentary habits. Secondary intervention  Those from the intervention group who are overweight(based on standard deviation of BMI =3) will be followed monthly at home by community health agents.  It is coordinated by the Health Secretary of the Municipality of Duque de Caxias and will be carried out from June to December 2016 by the CHA.  They will visit family every month and encourage life style changes at family level .
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  • 11. Data collection method at school  Baseline questionnaire pre intervention [March-April]  Post-intervention questionnaire [November-December] using personal digital assistant (PDA). Anthropometric and body composition  Weight, height and waist circumference at the lower value were measured using standardized procedures .  body composition estimated by bioelectrical impedance, using the leg-to-leg Tania scale .  Height was measured using a portable stadiometer.  Overweight and obesity classification of the World Health Organization was used . Food consumption  It will be assessed by 24-h recall and a short (23 items) food frequency questionnaire (FFQ), which is a reduced version of an FFQ validated for adolescents of Rio de Janeiro .  The 24-h recall will use the BrasilNutri software, entering data during interviews in schools. Measurement of physical activity  It will include the evaluation of exercise, leisure activities, commuting to school, and sedentary activities (video games, television and computer time) measured by questionnaire .
  • 12. Outcomes.  At the primary intervention level we are testing a reduction of 0.4 units of mean BMI .  Secondary prevention program a reduction of 1.1 units of BMI is expected. Secondary outcomes include body fat and waist circumference.  Many behavior changes evaluated will allow measure the adherence to the intervention.  The results of this study will be submitted for publication in next year and the methods presented may contribute to develop effective interventions to reduce the growing prevalence of obesity.
  • 13. Advantage of study  This is the first study that integrates school intervention with primary health care to prevent excessive weight gain among adolescents. Previous studies and most of the literature have shown inconsistent results of studies based on only in the school, thus this is a promising study.  There are no established guidelines for childhood obesity. Thus, this project will inform possible strategies to be disseminated in the health care system in Brazil .The CHA act in the territory in which she/he is affiliated and serve as a mediator between families and health professionals.  If positive results of the CHA intervention are observed, all CHA from Duque de Caxias, Rio de Janeiro will be trained and materials developed used in the primary health care.  Thus the current study presents the rationale and protocol development, pre-tests, and implementation of the trial PAAPPAS, which combine primary prevention activities at school level with secondary prevention at household level.  This study will provide evidence whether integration of school with primary health care can prevent excessive weight gain among adolescent.
  • 14. Limitations.  This study take place in one of the poorest areas in the state of Rio de Janeiro, intervention group will be having certain demographic characteristics which it will be different from other area and we cannot generalize the result to target population.  To avoid this problem the intervention studies should increase the diversity of human subjects.  If the intervention group is not following the prescribed methods the outcome maybe reduced.  Children may move into other community after the intervention has began may lead to loss of effect
  • 15.  Is obesity in children a public health issue?
  • 16. Public health importance  Overweight children and adolescents are more likely to become overweight or obese adults; this concern is greatest among adolescents.  Type 2 diabetes, high blood lipids, and hypertension as well as early maturation and orthopedic problems also occur with increased frequency in overweight youth overweight and obesity are associated with an increased risk of disease and death, as previously discussed.  Randomized controlled trials have shown that weight loss (as modest as 5 to 15 percent of excess total body weight) reduces the risk factors for at least some diseases, particularly cardiovascular disease, in the short term.
  • 17. Reference  Michele, R.S., Diana, B. C., Viviane, T. H., Camilla ,C. P., Estima, Bárbara, S. N., Souza, Rosangela, A. P., Edna M. Y., Vitor B.,. Paravidino and Rosely S. 17 August 2016. PAAPPAS community trial protocol: A randomized study of obesity prevention for adolescents combining school with household intervention. Http://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-016-3473-3