<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03041142</url>
  </required_header>
  <id_info>
    <org_study_id>33</org_study_id>
    <nct_id>NCT03041142</nct_id>
  </id_info>
  <brief_title>Program of Physical, Nutritional and Psychological Activities With Overweight Schoolchildren</brief_title>
  <acronym>PANPES</acronym>
  <official_title>Effects of an Interdisciplinary Intervention Program on Cardiovascular Risk Factors in Children With Overweight and Obesity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal do vale do São Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal do vale do São Francisco</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Obesity has been considered as one of the primary factors for the development of pathologies&#xD;
      and cardiovascular risk factors. In the child it has been mediator for the development of&#xD;
      these comorbidities still in childhood, in the adolescence and more strongly in the adult&#xD;
      age, at the time of most cardiovascular events with death records. Objective: To analyze the&#xD;
      effects of an interdisciplinary intervention program on the cardiovascular risk factors of&#xD;
      overweight and obese children. Methods: It was conducted a physical activity program,&#xD;
      nutritional and psychological orientations, lasting ten weeks with overweighed children and&#xD;
      their mothers. Thirty-three children with BMI considered overweight and obese participated in&#xD;
      the study, they were divided into two groups, experimental (n=14) and control (n=19).&#xD;
      Physical activities occurred 3 times a week with children and once a week with mothers.&#xD;
      Nutritional and psychological counseling occurred once a week with both children and mothers.&#xD;
      BMI, waist circumference, waist-height ratio, percentage of fat, cardiorespiratory fitness,&#xD;
      systolic and diastolic blood pressure, lipid profile, glucose, left ventricular mass, daily&#xD;
      energy intake and parental perception of children's weight were analyzed. For the statistical&#xD;
      analysis it was first verified the normality of the data by the Shappiro Wilk test, with the&#xD;
      variables that presented normality the possible differences were verified through the Anova&#xD;
      test of mixed design with the post hoc of Bonferroni, for the normal variables, but that&#xD;
      presented significant difference in the initial moment of the research, it was resorted to&#xD;
      the Ancova, finally, for the non-normal variables the &quot;U&quot; tests of Mann Whitney and Wilcoxon.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The intervention program was composed of physical activities, nutritional and psychological&#xD;
      monitoring. The same lasted 10 weeks, where the meetings took place on Tuesdays and Thursdays&#xD;
      with the children, in which they participated in 50 minutes of physical activity. On&#xD;
      Saturdays, children were exposed to physical activity, guidance on healthy eating, and&#xD;
      behavior change. On that day, mothers also participated in gym classes (duration of 50&#xD;
      minutes) and nutritional guidelines (duration of 50 minutes) and behavior change (duration of&#xD;
      120 minutes). It is noteworthy that the team was composed of ten psychology students and one&#xD;
      teacher from the same area, three nutritionists, two teachers and five physical education&#xD;
      students and four physicians.&#xD;
&#xD;
      Physical activities consisted of games and popular games lasting 50-60 minutes. Thus, in&#xD;
      order to keep the children physically active as long as possible, timing was 2 minutes&#xD;
      interval for water between each activity, resulting in a total time of 6 minutes rest&#xD;
      throughout the class. Thus, there were 30 physical activity sessions with the children.&#xD;
&#xD;
      On Saturdays, mothers also participated in physical activities. Aerobic gymnastics and&#xD;
      functional training were developed, lasting 50 minutes. During the classes, mothers were&#xD;
      instructed to stay physically active during the week, performing, if possible, some physical&#xD;
      activity at least five days a week.&#xD;
&#xD;
      On Saturdays, children were also submitted to guidelines on healthy eating, where they were&#xD;
      encouraged to eat the right way, also learned about the importance of food, the group to&#xD;
      which each food is a part, especially the foods they make Part of the context of the child,&#xD;
      learned a variety of fruits and vegetables, learned how to prepare their own healthy snack&#xD;
      and were motivated to take the acquired knowledge home, stimulating the whole family to&#xD;
      adhere to healthier eating habits.&#xD;
&#xD;
      Nutrition counseling was also carried out with the mothers. At the meetings the nutritional&#xD;
      needs for the age group of their children were exposed, the ideal foods to be consumed at&#xD;
      each moment of the day, knowledge about the group to which each food belongs, adequate food&#xD;
      According to the financial conditions, and a little book of recipes was created, where the&#xD;
      food, fruits and typical dishes of the local region were emphasized, but in a healthier way.&#xD;
&#xD;
      Behavior change was stimulated by therapy with psychology trainees. The children were divided&#xD;
      into 2 groups, to facilitate the process of psychological monitoring. The meetings were held&#xD;
      once a week, on Saturdays, where activities and dynamics were developed with the aim of&#xD;
      encouraging adherence to healthy habits, both food and physical activity. The therapies&#xD;
      happened during 1 hour and they occurred in a playful way to involve all the universe of the&#xD;
      child.&#xD;
&#xD;
      Mothers also had their moments of therapy, where they were motivated to be role models for&#xD;
      their children, to stimulate this change in the children's lifestyle, they were also&#xD;
      challenged to engage in some healthy activity during the week, at times alone, In others in&#xD;
      the company of their children. Psychological encounters with mothers occurred on Saturdays,&#xD;
      and they were divided into two groups to ensure greater control over the activities&#xD;
      developed, as well as for them to feel more comfortable talking about themselves and their&#xD;
      children. Parental relationships were extensively worked on in this practice. The meetings&#xD;
      lasted two hours.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2015</start_date>
  <completion_date type="Actual">July 3, 2016</completion_date>
  <primary_completion_date type="Actual">April 1, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight in kilograms</measure>
    <time_frame>5 minutes</time_frame>
    <description>The weight was determined on Wiso® digital platform, model W801, with a precision of up to 100 g.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Height in meters</measure>
    <time_frame>5 minutes</time_frame>
    <description>The stature was determined by means of a metal tape measure Sanny® attached to the wall, with precision of 0.1 cm.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood Pressure in millimeters of mercury</measure>
    <time_frame>20 minutes</time_frame>
    <description>In order to measure blood pressure values among children, the Omron device (HEM 742) was used, consisting of an electronic and digital arm device, with inflation and automatic air deflation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lipid profile in milligrams per deciliter</measure>
    <time_frame>20 minutes</time_frame>
    <description>For the dosages of the biochemical profile (triglycerides, total cholesterol, HDL-C and LDL-C) the blood was collected at the school itself by a nursing technique and the samples were taken to be analyzed in a specialized laboratory.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Left ventricular mass in grams</measure>
    <time_frame>30 minutes</time_frame>
    <description>Transthoracic echocardiography was performed using the Vivid S6 echocardiogram model of the General Eletric® brand, year of manufacture 2011.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical activity in minutes and bouts</measure>
    <time_frame>8 days.</time_frame>
    <description>The level of physical activity was assessed using the Actigraph GT3X + accelerometer model (ActiGraph®, USA). The child wore the device at the waist for 8 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sedentary behavior in minutes and bouts</measure>
    <time_frame>8 days</time_frame>
    <description>The sedentary behavior was assessed using the Actigraph GT3X + accelerometer model (ActiGraph®, USA). The child wore the device at the waist for 8 days.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Cardiovascular Risk Factor</condition>
  <arm_group>
    <arm_group_label>Interdisciplinary Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children 3 sessions/week 50-60 minutes of physical activity;&#xD;
1 session/week 60 minutes nutrition education week;&#xD;
1 session/week 120 minutes behaviour therapy.&#xD;
Mothers&#xD;
1 sessions/week 50-60 minutes of physical activity;&#xD;
1 session/week 60 minutes nutrition education week;&#xD;
1 session/week 120 minutes behaviour therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Routine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Mothers and children followed their routine activities</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Interdisciplinary intervention</intervention_name>
    <description>Physical Activity, nutrition and Psychological</description>
    <arm_group_label>Interdisciplinary Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Routine</intervention_name>
    <description>The participants continued to maintain their routine</description>
    <arm_group_label>Routine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Are regularly enrolled in municipal schools in the city of Petrolina-Pernambuco;&#xD;
&#xD;
          -  They are classified as overweight or obese according to the criteria used by the&#xD;
             researchers;&#xD;
&#xD;
          -  Do not present restrictions to the practice of physical activities;&#xD;
&#xD;
          -  Do not use medications that may interfere with your search results.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  That they refuse to participate at some point in the data collection;&#xD;
&#xD;
          -  That they have some restriction to the practices developed in the research, acquired&#xD;
             during the course of the study;&#xD;
&#xD;
          -  That they present a number greater than 50% of absences in the proposed activities;&#xD;
&#xD;
          -  That parents or guardians miss four meetings or more.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>9 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ferdinando O Carvalho, Doctor</last_name>
    <role>Study Director</role>
    <affiliation>Federal university of san francisco valley</affiliation>
  </overall_official>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>February 2, 2017</last_update_submitted>
  <last_update_submitted_qc>February 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal do vale do São Francisco</investigator_affiliation>
    <investigator_full_name>THAYNA BEZERRA</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Cardiovascular risk factors</keyword>
  <keyword>Interdisciplinary intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03041142
org study id: 33
nct id: NCT03041142
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Obesity has been considered as one of the primary factors for the development of pathologies
      and cardiovascular risk factors. In the child it has been mediator for the development of
      these comorbidities still in childhood, in the adolescence and more strongly in the adult
      age, at the time of most cardiovascular events with death records. Objective: To analyze the
      effects of an interdisciplinary intervention program on the cardiovascular risk factors of
      overweight and obese children. Methods: It was conducted a physical activity program,
      nutritional and psychological orientations, lasting ten weeks with overweighed children and
      their mothers. Thirty-three children with BMI considered overweight and obese participated in
      the study, they were divided into two groups, experimental (n=14) and control (n=19).
      Physical activities occurred 3 times a week with children and once a week with mothers.
      Nutritional and psychological counseling occurred once a week with both children and mothers.
      BMI, waist circumference, waist-height ratio, percentage of fat, cardiorespiratory fitness,
      systolic and diastolic blood pressure, lipid profile, glucose, left ventricular mass, daily
      energy intake and parental perception of children's weight were analyzed. For the statistical
      analysis it was first verified the normality of the data by the Shappiro Wilk test, with the
      variables that presented normality the possible differences were verified through the Anova
      test of mixed design with the post hoc of Bonferroni, for the normal variables, but that
      presented significant difference in the initial moment of the research, it was resorted to
      the Ancova, finally, for the non-normal variables the "U" tests of Mann Whitney and Wilcoxon.
The intervention program was composed of physical activities, nutritional and psychological
      monitoring. The same lasted 10 weeks, where the meetings took place on Tuesdays and Thursdays
      with the children, in which they participated in 50 minutes of physical activity. On
      Saturdays, children were exposed to physical activity, guidance on healthy eating, and
      behavior change. On that day, mothers also participated in gym classes (duration of 50
      minutes) and nutritional guidelines (duration of 50 minutes) and behavior change (duration of
      120 minutes). It is noteworthy that the team was composed of ten psychology students and one
      teacher from the same area, three nutritionists, two teachers and five physical education
      students and four physicians.

      Physical activities consisted of games and popular games lasting 50-60 minutes. Thus, in
      order to keep the children physically active as long as possible, timing was 2 minutes
      interval for water between each activity, resulting in a total time of 6 minutes rest
      throughout the class. Thus, there were 30 physical activity sessions with the children.

      On Saturdays, mothers also participated in physical activities. Aerobic gymnastics and
      functional training were developed, lasting 50 minutes. During the classes, mothers were
      instructed to stay physically active during the week, performing, if possible, some physical
      activity at least five days a week.

      On Saturdays, children were also submitted to guidelines on healthy eating, where they were
      encouraged to eat the right way, also learned about the importance of food, the group to
      which each food is a part, especially the foods they make Part of the context of the child,
      learned a variety of fruits and vegetables, learned how to prepare their own healthy snack
      and were motivated to take the acquired knowledge home, stimulating the whole family to
      adhere to healthier eating habits.

      Nutrition counseling was also carried out with the mothers. At the meetings the nutritional
      needs for the age group of their children were exposed, the ideal foods to be consumed at
      each moment of the day, knowledge about the group to which each food belongs, adequate food
      According to the financial conditions, and a little book of recipes was created, where the
      food, fruits and typical dishes of the local region were emphasized, but in a healthier way.

      Behavior change was stimulated by therapy with psychology trainees. The children were divided
      into 2 groups, to facilitate the process of psychological monitoring. The meetings were held
      once a week, on Saturdays, where activities and dynamics were developed with the aim of
      encouraging adherence to healthy habits, both food and physical activity. The therapies
      happened during 1 hour and they occurred in a playful way to involve all the universe of the
      child.

      Mothers also had their moments of therapy, where they were motivated to be role models for
      their children, to stimulate this change in the children's lifestyle, they were also
      challenged to engage in some healthy activity during the week, at times alone, In others in
      the company of their children. Psychological encounters with mothers occurred on Saturdays,
      and they were divided into two groups to ensure greater control over the activities
      developed, as well as for them to feel more comfortable talking about themselves and their
      children. Parental relationships were extensively worked on in this practice. The meetings
      lasted two hours.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Weight in kilograms
time frame: 5 minutes
description: The weight was determined on Wiso® digital platform, model W801, with a precision of up to 100 g.
measure: Height in meters
time frame: 5 minutes
description: The stature was determined by means of a metal tape measure Sanny® attached to the wall, with precision of 0.1 cm.
measure: Blood Pressure in millimeters of mercury
time frame: 20 minutes
description: In order to measure blood pressure values among children, the Omron device (HEM 742) was used, consisting of an electronic and digital arm device, with inflation and automatic air deflation.
measure: Lipid profile in milligrams per deciliter
time frame: 20 minutes
description: For the dosages of the biochemical profile (triglycerides, total cholesterol, HDL-C and LDL-C) the blood was collected at the school itself by a nursing technique and the samples were taken to be analyzed in a specialized laboratory.
measure: Left ventricular mass in grams
time frame: 30 minutes
description: Transthoracic echocardiography was performed using the Vivid S6 echocardiogram model of the General Eletric® brand, year of manufacture 2011.
measure: Physical activity in minutes and bouts
time frame: 8 days.
description: The level of physical activity was assessed using the Actigraph GT3X + accelerometer model (ActiGraph®, USA). The child wore the device at the waist for 8 days.
measure: Sedentary behavior in minutes and bouts
time frame: 8 days
description: The sedentary behavior was assessed using the Actigraph GT3X + accelerometer model (ActiGraph®, USA). The child wore the device at the waist for 8 days.
arm group label: Interdisciplinary Intervention
arm group type: Experimental
description: Children 3 sessions/week 50-60 minutes of physical activity;
1 session/week 60 minutes nutrition education week;
1 session/week 120 minutes behaviour therapy.
Mothers
1 sessions/week 50-60 minutes of physical activity;
1 session/week 60 minutes nutrition education week;
1 session/week 120 minutes behaviour therapy.
arm group label: Routine
arm group type: Active Comparator
description: Mothers and children followed their routine activities
intervention type: Behavioral
intervention name: Interdisciplinary intervention
description: Physical Activity, nutrition and Psychological
arm group label: Interdisciplinary Intervention
intervention type: Other
intervention name: Routine
description: The participants continued to maintain their routine
arm group label: Routine
criteria: 
gender: All
minimum age: 6 Years
maximum age: 9 Years
healthy volunteers: No
last name: Ferdinando O Carvalho, Doctor
role: Study Director
affiliation: Federal university of san francisco valley
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal do vale do São Francisco
investigator full name: THAYNA BEZERRA
investigator title: Principal Investigator
mesh term: Overweight
sharing ipd: No